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Hysteroscopy for treating subfertility associated with suspected major uterine cavity abnormalities

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Referencias

Casini 2006 {published data only}

Casini ML, Rossi F, Agostini R, Unfer V. Effects of the position of fibroids on fertility. Gynecological Endocrinology 2006;22(2):106–9. [DOI: 10.1080/09513590600604673; PMID: 16603437]

Pérez‐Medina 2005 {published data only}

Pérez‐Medina T, Bajo‐Arenas J, Salazar F, Redondo T, Sanfrutos L, Alvarez P, et al. Endometrial polyps and their implication in the pregnancy rates of patients undergoing intrauterine insemination: a prospective, randomized study. Human Reproduction 2005;20(6):1632‐5. [DOI: 10.1093/humrep/deh822; PMID: 5760959]

Abu Rafea 2013 {published data only}

Abu Rafea BF, Vilos GA, Oraif AM, Power SG, Cains JH, Vilos AG. Fertility and pregnancy outcomes following resectoscopic septum division with and without intrauterine balloon stenting: a randomized pilot study. Annals of Saudi Medicine 2013;33(1):34‐9. [DOI: 10.5144/0256‐4947.2013.34]

Acunzo 2003 {published data only}

Acunzo G, Guida M, Pellicano M, Tommaselli GA, Di Spiezio Sardo A, Bifulco G, et al. Effectiveness of auto‐cross‐linked hyaluronic acid gel in the prevention of intrauterine adhesions after hysteroscopic adhesiolysis: a prospective, randomized, controlled study. Human Reproduction 2003;18(9):1918‐21. [DOI: 10.1093/humrep/deg368; PMID: 12923149]

Aghahosseini 2012 {published data only}

Aghahosseini M, Ebrahimi N, Mahdavi A, Aleyasin A, Safdarian L, Sina S. Hysteroscopy prior to assisted reproductive technique in women with recurrent implantation failure improves pregnancy likelihood. Fertility and Sterility 2012;98(3 Suppl):S4, O‐13. [DOI: 10.1016/j.fertnstert.2012.07.015]

Amer 2010 {published data only}

Amer MI, Abd‐El‐Maeboud KHI, Abdelfatah I, Salama FA, Abdallah AS. Human amnion as a temporary biologic barrier after hysteroscopic lysis of severe intrauterine adhesions: pilot study. Journal of Minimally Invasive Gynecology 2010;17(5):605‐11. [DOI: 10.1016/j.jmig.2010.03.019; PMID: 20576472 ]

Colacurci 2007 {published data only}

Colacurci N, De Franciscis P, Mollo A, Litta P, Perino A, Cobellis L, et al. Small‐diameter hysteroscopy with Versapoint versus resectoscopy with a unipolar knife for the treatment of septate uterus: a prospective randomized study. Journal of Minimally Invasive Gynecology 2007;14:622–7. [DOI: 10.1016/j.jmig.2007.04.010; PMID: 17848325]

Darwish 2008 {published data only}

Darwish AM. Extended resectoscopic versus sequentional cold knife‐resectoscopic excision of the unclassified complete uterocervicovaginal septum: a randomized trial. Fertility and Sterility 2008;90(Suppl):S446. [DOI: 10.1016/j.fertnstert.2008.07.968; ISSN: 0015‐0282]
Darwish AM, Elsaman AM. Extended resectoscopic versus sequential cold knife‐resectoscopic excision of the unclassified complete uterocervicovaginal septum: a randomized trial. Fertility and Sterility 2009;92(2):722‐6. [DOI: 10.1016/j.fertnstert.2008.06.019; PMID: 18692837 ]

De Angelis 2010 {published data only}

De Angelis C, Antinori M, Cerusico V, Antinori, S. Hysteroscopic surgery prior to IVF. Reproductive Biomedicine Online 2010;20 Suppl 3:S81.

De Iaco 2003 {published data only}

De Iaco PA, Muzzupapa G, Bovicelli A, Marconi S, Bitti SR, Sansovini M, et al. Hyaluronan derivative gel (Hyalobarrier gel®) in intrauterine adhesion prevention after operative hysteroscopy. Ellipse 2003;19(1):15‐8.

Demirol 2004 {published data only}

Demirol A, Gurgan T. Effect of treatment of intrauterine pathologies with office hysteroscopy in patients with recurrent IVF failure. Reproductive BioMedicine Online 2004;8(5):590‐4. [Accession number: 13019241; PMID: 15151729]

Di Spiezio Sardo 2011 {published data only}

Di Spiezio Sardo A, Spinelli M, Bramante S, Scognamiglio M, Greco E, Guida M, et al. Efficacy of a polyethylene oxide–sodium carboxymethylcellulose gel in prevention of intrauterine adhesions after hysteroscopic surgery. Journal of Minimally Invasive Gynecology 2011;18:462‐9. [DOI: 10.1016/j.jmig.2011.04.007; PMID: 21777835 ]

El‐Nashar 2011 {published data only}

El‐Nashar IH, Nasr A. The role of hysteroscopy before intracytoplasmic sperm injection (ICSI): a randomized controlled trial. Fertility and Sterility 2011;96(3 Suppl):S266. [DOI: 10.1016/j.fertnstert.2011.07.1016; ISSN: 0015‐0282]

Elsetohy 2015 {published data only}

Elsetohy KA, Askalany AH, Hassan M, Dawood Z. Routine office hysteroscopy prior to ICSI vs. ICSI alone in patients with normal transvaginal ultrasound: a randomized controlled trial. Archives of Gynecology and Obstetrics 2015;291(1):193‐9. [DOI: 10.1007/s00404‐014‐3397‐z]

El‐Toukhy 2009 {published and unpublished data}

El‐Toukhy T. TRial of OutPatient HYsteroscopy in in‐vitro fertilisation (IVF) Trophy in IVF [A multicentre randomised controlled study of the effects of outpatient hysteroscopy on the outcome of the subsequent in‐vitro fertilisation (IVF) cycle after recurrent IVF failure]. World Health Organization International Clinical Trials Registry Platform search portal2009. [ISRCTN: ISRCTN35859078]
El‐Toukhy T, Campo R, Sunkara SK, Khalaf Y, Coomarasamy A. A multi‐centre randomised controlled study of pre‐IVF outpatient hysteroscopy in women with recurrent IVF implantation failure: Trial of Outpatient Hysteroscopy ‐ [TROPHY] in IVF. Reproductive Health 2009;6:20. [DOI: 10.1186/1742‐4755‐6‐20; PMCID: 2795733]
El‐Toukhy T, Khalaf Y, Coomarasamy A, Tabanelli C, Gordts SS, Gordts S, et al. A multicentre randomised study of pre‐IVF outpatient hysteroscopy in women with recurrent IVF‐ET failure‐the TROPHY trial. Human Reproduction (Oxford, England) 2014;29(Supp 1):i36‐7.

Fatemi 2007 {unpublished data only}

Fatemi HM, Devroey P, Fauser B, Broekmans FJ, Kasius JC. The impact of treating minor uterine cavity abnormalities diagnosed by office hysteroscopy in unselected in vitro fertilization (IVF) cases [Comparative controlled trial of treatment of minor unexpected uterine cavity abnormalities diagnosed by office hysteroscopy screening in women Indicated for IVF]. World Health Organization International Clinical Trials Registry Platform search portal2007. [CTG: NCT00830401]

Gao 2013 {unpublished data only}

Gao M. Hysteroscopy assess and improve uterine receptivity for women with repeated implantation failure [Clinical research of hysteroscopy to assess and improve uterine receptivity for women with repeated implantation failure]. World Health Organization International Clinical Trials Registry Platform search portal2013. [ChiCTR: ChiCTR‐ONRC‐13003882]

Guida 2004 {published data only}

Guida M, Acunzo G, Di Spiezio Sardo A, Bifulco G, Piccoli R, Pellicano M, et al. Effectiveness of auto‐crosslinked hyaluronic acid gel in the prevention of intrauterine adhesions after hysteroscopic surgery: a prospective, randomized, controlled study. Human Reproduction 2004;19(6):1461‐4. [DOI: 10.1093/humrep/deh238; PMID: 15105384]

Lieng 2010a {published data only}

Lieng M, Istre O, Sandvik L, Engh V, Qvigstad E. Clinical effectiveness of transcervical polyp resection in women with endometrial polyps: randomized controlled trial. Journal of Minimally Invasive Gynecology 2010;17(3):351‐7. [DOI: 10.1016/j.jmig.2010.01.019; PMID: 20417427 ]

Lin 2014 {unpublished data only}

Lin X, Wei ML, Li TC, Zhou F, Zhang SY. A prospective randomized control trial to compare the efficacy of intrauterine balloon and intrauterine contraceptive device in the prevention of adhesion reformation following hysteroscopic adhesiolysis. Gynecological Surgery 2014;11(1):89‐90. [ISRCTN: ISRCTN6969027269690272]

Mohammed 2014 {unpublished data only}

Mohammed AM, Gomaa MF. Value of routine hysteroscopy prior to IVF/ICSI Cycles. World Health Organization International Clinical Trials Registry Platform search portal2014. [CTG: NCT02245750]

Muzii 2007 {published data only}

Muzii L, Bellati F, Pernice M, Manci N, Angioli R, Panici PB. Resectoscopic versus bipolar electrode excision of endometrial polyps: a randomized study. Fertility and Sterility 2007;87(4):909‐17. [DOI: 10.1016/j.fertnstert.2006.08.113; PMID: 17239873]

Pabuccu 2008 {published data only}

Pabuccu R, Onalan G, Kaya C, Selam B, Ceyhan T, Ornek T, et al. Efficiency and pregnancy outcome of serial intrauterine device‐guided hysteroscopic adhesiolysis of intrauterine synechiae. Fertility and Sterility 2008;90(5):1973‐7. [DOI: 10.1016/j.fertnstert.2007.06.074; PMID: 18774563]

Pansky 2009 {unpublished data only}

Pansky M. Efficiency of Intercoat (Oxiplex/AP Gel) in decreasing intrauterine adhesions [Intercoat (Oxiplex/AP Gel) for preventing intrauterine adhesions following operative hysteroscopy for suspected retained products of conception ‐ a prospective randomized pilot study]. World Health Organization International Clinical Trials Registry Platform search portal2012. [CTG: NCT01377779]

Parsanezhad 2006 {published data only}

Parsanezhad ME, Alborzi S, Zarei A, Dehbashi S, Shirazi LG, Rajaeefard A, et al. Hysteroscopic metroplasty of the complete uterine septum, duplicate cervix, and vaginal septum. Fertility and Sterility 2006;85(5):1473‐7. [DOI: 10.1016/j.fertnstert.2005.10.044; PMID: 16600229 ]

Rama Raju 2006 {published data only}

Rama Raju GA, Shashi Kumari G, Krishna KM, Prakash GJ, Madan K. Assessment of uterine cavity by hysteroscopy in assisted reproduction programme and its influence on pregnancy outcome. Archives of Gynecology and Obstetrics 2006;274(3):160‐4. [DOI: 10.1007/s00404‐006‐0174‐7; PMID: 16715289]

Shawki 2010 {published data only}

Shawki HE, Elmorsy M, Eissa MK. Routine office hysteroscopy prior to ICSI and its impact on assisted reproduction program outcome: a randomized controlled trial. Middle East Fertility Society Journal 2012;17(1):14‐21. [DOI: 10.1016/j.mefs.2011.04.005]

Shokeir 2010 {published data only}

Shokeir T, El‐Shafei M, Yousef H, Allam AF, Sadek E. Submucous myomas and their implications in the pregnancy rates of patients with otherwise unexplained primary infertility undergoing hysteroscopic myomectomy: a randomized matched control study. Fertility and Sterility 2010;94(2):724‐9. [DOI: 10.1016/j.fertnstert.2009.03.075; PMID: 19406399]

Tonguc 2008 {published data only}

Tonguc EA, Var T, Yilmaz N, Batioglu S. Intrauterine device or estrogen treatment after hysteroscopic uterine septum resection. International Journal of Gynaecology and Obstetrics 2010;109(3):226‐9. [DOI: 10.1016/j.ijgo.2009.12.015; PMID: 20152976]
Tonguc EA, Var T, Yilmaz N, Batioglu S. Management after hysteroscopic metroplasty: with or without intrauterine device (IUD) insertion and estrogen administration. Fertility and Sterility 2008;90(Suppl):S165. [DOI: 10.1016/j.fertnstert.2008.07.918]

Trninić‐Pjević 2011 {published data only}

Trninić‐Pjević A, Kopitović V, Pop‐Trajković S, Bjelica A, Bujas I, Tabs D, et al. Effect of hysteroscopic examination on the outcome of in vitro fertilization. Vojnosanit Pregl 2011;68(6):476‐80. [Accession number: 21818913]

van Dongen 2008 {published data only}

Emanuel MH, van Dongen H, Jansen FW. Hysteroscopic morcellator for removal of intrauterine polyps and myomas: a randomized controlled study among residents in training. Fertility and Sterility 2009;92(3 Suppl):S5. [DOI: 10.1016/j.fertnstert.2009.07.019]
van Dongen H, Emanuel MH, Wolterbeek R, Trimbos JB, Jansen FW. Hysteroscopic morcellator for removal of intrauterine polyps and myomas: a randomized controlled pilot study among residents in training. Journal of Minimally Invasive Gynecology 2008;15(4):466‐71. [DOI: 10.1016/j.jmig.2008.02.002; PMID: 18588849]

Vercellini 1993 {published data only}

Vercellini P, Vendola N, Colombo A, Passadore C, Trespidi L, Fedele L. Hysteroscopic metroplasty with resectoscope or microscissors for the correction of septate uterus. Surgery, Gynecology and Obstetrics 1993;176(5):439‐42. [PMID: 8480265]

Youssef 2013 {published data only}

Youssef HM. Uterine septum dissection using mini‐hysteroscopy with bipotrode 5 fr bipolar electrode versus monopolar resectoscopy with a unipolar knife: A randomized controlled study. Fertility and Sterility 2013;100(3 Suppl 1):S394.

Clark 2014 {unpublished data only}

Clark TJ. A randomised controlled trial of Outpatient Polyp Treatment for abnormal uterine bleeding (OPT). World Health Organization International Clinical Trials Registry Platform search portal2008. [ISRCTN: ISRCTN65868569]

Moramezi 2012 {published and unpublished data}

Moramezi F. Effect of hysteroscopy before intra uterine insemination on fertility in infertile couples [Effect of hysteroscopy before intra uterine insemination on fertility in infertile couples patients referred to Imam Khomeini Hospital, Ahwaz IVF]. World Health Organization International Clinical Trials Registry Platform search portal2012. [IRCT: IRCT201201308867N1]
Moramezi F, Barati M, Mohammadjafari R, Barati S, Hemadi M. Effect of hysteroscopy before intra uterine insemination on fertility in infertile couples. Pakistan Journal of Biological Sciences: PJBS 2012;15(19):942‐6. [PUBMED: 24159691]

Abiri 2014 {unpublished data only}

Abiri A. The effect of hysteroscopy prior IVF on creating successful pregnancy [The effect of hysteroscopy on successful pregnancy in IVF in the infertile women who are candidate for the first IVF cycle]. World Health Organization International Clinical Trials Registry Platform search portal2014. [IRCT: IRCT2014052616912N4]

Basma 2013 {unpublished data only}

Basma E, Elmaghraby H. Hysteroscopy before first trial ICSI [Role of hysteroscopy before first trial ICSI: A prospective randomized controlled trial]. World Health Organization International Clinical Trials Registry Platform search portal2013. [PACTR: PACTR201402000691997]

Broekmans 2010 {published and unpublished data}

Broekmans FJM. SIGnificance of Routine Hysteroscopy Prior to a First 'in Vitro Fertilization' (IVF) Treatment Cycle (inSIGHT) [SIGnificance of Routine Hysteroscopy Prior to a First 'in Vitro Fertilization' (IVF) Treatment Cycle]. World Health Organization International Clinical Trials Registry Platform search portal2010. [CinicalTrials.gov: NCT01242852]
Smit JG, Kasius JC, Eijkemans MJC, Koks CAM, Van Golde R, Oosterhuis JGE, et al. The inSIGHT study: costs and effects of routine hysteroscopy prior to a first IVF treatment cycle. A randomised controlled trial. BMC Women's Health 2012;12:22. [DOI: 10.1186/1472‐6874‐12‐22; http: //www.biomedcentral.com/1472‐6874/12/22]

El‐Khayat 2012 {unpublished data only}

El‐Khayat W. Office hysteroscopy and endometrial snip improve intrauterine insemination outcome [Does office hysteroscopy and endometrial snip improve IUI outcome?: A randomized controlled trial]. World Health Organization International Clinical Trials Registry Platform search portal2012. [CTG: NCT01544426]

Hare 2013 {unpublished data only}

Hare KJ. Hysteroscopy before in vitro fertilization ‐ Does it improve the outcome?. World Health Organization International Clinical Trials Registry Platform search portal2013. [CTG: NCT01743391]

Revel 2011 {unpublished data only}

Revel A. Safety study of use of hyaluronic acid gel to prevent intrauterine adhesions in hysteroscopic surgery. Current Controlled Trials2011. [CTG: NCT01464528]

Sohrabvand 2012 {unpublished data only}

Sohrabvand F. Evaluation of diagnostic hysteroscopy findings in patients candidate ART (IVF, ICSI) [Evaluation of diagnostic hysteroscopy findings in patients candidate for ART (IVF, ICSI) and its effect on pregnancy rate compared to control group]. Current Controlled Trials2012. [IRCT: IRCT201208152565N6]

Weiss 2005 {unpublished data only}

Weiss A, Shalev E, Geslevich J. Endometrial curettage before embryo transfer [Endometrial hysteroscopy and curettage prior to embryo transfer]. World Health Organization International Clinical Trials Registry Platform search portal2005. [CTG: NCT00367367]

Andersen 2008

Andersen AN, Goossens V, Ferraretti AP, Bhattacharya S, Felberbaum R, de Mouzon J, et al. Assisted reproductive technology in Europe, 2004: results generated from European registers by ESHRE. Human Reproduction 2008;23:756‐71. [DOI: 10.1093/humrep/den014; PMID: 18281243]

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Bosteels J, Kasius J, Weyers S, Broekmans FJ, Mol BWJ, D'Hooghe TM. Hysteroscopy for treating subfertility associated with suspected major uterine cavity abnormalities. Cochrane Database of Systematic Reviews 2011, Issue 11. [DOI: 10.1002/14651858.CD009461]

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Campo R, Molinas CR, Rombauts L, Mestdagh G, Lauwers M, Braekmans P, et al. Prospective multicentre randomised controlled trial to evaluate factors influencing the success rate of office diagnostic hysteroscopy. Human Reproduction 2005;20(1):258‐63. [DOI: 10.1093/humrep/deh559; PMID: 15550496]

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Clark TJ, Gupta JK. Handbook of Outpatient Hysteroscopy. A Complete Guide to Diagnosis and Therapy. Hodder Education, 2005.

De Placido 2007

De Placido G, Clarizia R, Cadente C, Castaldo G, Romano C, Mollo A, et al. Compliance and diagnostic efficacy of mini‐hysteroscopy versus traditional hysteroscopy in infertility investigation. European Journal of Obstetrics, Gynecology, and Reproductive Biology 2007;135(1):83‐7. [DOI: 10.1016/j.ejogrb.2007.02.028; PMID: 17481803]

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Donnez J, Jadoul P. What are the implications of myomas on fertility? A need for debate?. Human Reproduction 2002;17:1424‐30. [DOI: 10.1093/humrep/17.6.1424; PMID: 12042254]

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Fatemi HM, Kasius JC, Timmermans A, van Disseldorp J, Fauser BC, Devroey P, et al. Prevalence of unsuspected uterine cavity abnormalities diagnosed by office hysteroscopy prior to in vitro fertilization. Human Reproduction 2010;25(8):1959‐65. [DOI: 10.1093/humrep/deq150; PMID: 20570971]

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Jayaprakasan K, Polanski L, Sahu B, Thornton JG, Raine‐Fenning N. Surgical intervention versus expectant management for endometrial polyps in subfertile women. Cochrane Database of Systematic Reviews 2014, Issue 8. [DOI: 10.1002/14651858.CD009592]

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Silberstein T, Saphier O, van Voorhis BJ, Plosker SM. Endometrial polyps in reproductive‐age fertile and infertile women. The Israel Medical Association Journal 2006;8:192‐5. [PMID: 16599056]

Singh 2011

Singh M, Chaudhry P, Asselin E. Bridging endometrial receptivity and implantation; network of hormones, cytokines, and growth factors. Journal of Endocrinology 2011;210:5‐14. [DOI: 10.1530/JOE‐10‐0461; PMID: 21372150]

Somigliana 2007

Somigliana E, Vercellini P, Daguati R, Pasin R, De Giorgi O, Crosignani PG. Fibroids and female reproduction: a critical analysis of the evidence. Human Reproduction Update 2007;13:465‐76. [DOI: 10.1093/humupd/dmm013; PMID: 17584819]

Spiessens 2003

Spiessens C, Vanderschueren D, Meuleman C, D’Hooghe T. Isolated teratozoospermia and intrauterine insemination. Fertility and Sterility 2003;80(5):1185‐9. [DOI: 10.1016/S0015‐0282(03)01172‐5; PMID: 14607572]

Taylor 2008

Taylor E, Gomel V. The uterus and fertility. Fertility and Sterility 2008;89(1):1‐15. [DOI: 10.1016/j.fertnstert.2007.09.069; PMID: 18155200]

Tomaževič 2010

Tomaževič T, Ban‐Frangež H, Virant‐Klun I, Verdenik I, Požlep B, Vrta nik‐Bokal E. Septate, subseptate and arcuate uterus decrease pregnancy and live birth rates in IVF/ ICSI. Reproductive Biomedicine Online 2010;21(5):700‐5. [DOI: 10.1016/j.rbmo.2010.06.028; PMID: 20864409]

Veltman‐Verhulst 2012

Veltman‐Verhulst SM, Cohlen BJ, Hughes E, Heineman MJ. Intra‐uterine insemination for unexplained subfertility. Cochrane Database of Systematic Reviews 2012, Issue 9. [DOI: 10.1002/14651858.CD001838.pub4]

Wallach 1972

Wallach EE. The uterine factor in infertility. Fertility and Sterility 1972;23(2):138‐58. [PMID: 4551503]

Wamsteker 1998

Wamsteker K, De Block S. Diagnostic hysteroscopy: technique and documentation. Endoscopic Surgery for Gynecologists. London: Saunders, 1998:511‐24.

Yanaihara 2008

Yanaihara A, Yorimitsu T, Motoyama H, Iwasaki S, Kawamura T. Location of endometrial polyp and pregnancy rate in infertility patients. Fertility and Sterility 2008;90:180‐2. [DOI: 10.1016/j.fertnstert.2007.05.072; PMID: 17889854]

Yu 2008

Yu D, Li TC, Xia E, Huang X, Liu Y, Peng X. Factors affecting reproductive outcome of hysteroscopic adhesiolysis for Asherman's syndrome. Fertility and Sterility 2008;89(3):715‐22. [DOI: 10.1016/j.fertnstert.2007.03.070; PMID: 17681324]

Zegers‐Hochschild 2009

Zegers‐Hochschild F, Adamson GD, de Mouzon J, Mansour R, Nygren K, Sullivan E, et al. International Committee for Monitoring Assisted Reproductive Technology (ICMART) and the World Health Organization (WHO) revised glossary of ART terminology, 2009. Fertility and Sterility 2009;92(5):1520‐4. [DOI: 10.1016/j.fertnstert.2009.09.009; PMID: 19828144]

Bosteels 2010

Bosteels J, Weyers S, Puttemans P, Panayotidis C, van Herendael B, Gomel V, et al. The effectiveness of hysteroscopy in improving pregnancy rates in subfertile women without other gynaecological symptoms: a systematic review. Human Reproduction Update 2010;16(1):1‐11. [DOI: 10.1093/humupd/dmp033; PMID: 19744944]

Bosteels 2013

Bosteels J, Kasius J, Weyers S, Broekmans FJ, Mol BWJ, D'Hooghe TM. Hysteroscopy for treating subfertility associated with suspected major uterine cavity abnormalities. Cochrane Database of Systematic Reviews 2013, Issue 1. [DOI: 10.1002/14651858.CD009461.pub2]

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Casini 2006

Methods

Parallel‐group, randomised, controlled, single‐centre trial

Power calculation not reported

Approved by the hospital's ethics committee

No source of funding or conflict of interest reported

Participants

Country: Italy

Setting: AGUNCO Obstetrics and Gynecology Centre, Rome

Population: women referred to the centre from January 1998 until April 2005 for fertility problems were examined for inclusion in the study. All women underwent routine examinations including the study of ovarian function (FSH, luteinising hormone, estradiol and progesterone concentrations); prolactin, free triiodothyronine, free thyroxine and thyroid‐stimulating hormone concentrations; post‐coital test; TVUS; hysterosalpingography; and analysis of the partner’s semen. The TVUS was performed in order to diagnose the presence of uterine fibroids. After these examinations all patients who were found to be affected by uterine fibroids excluding all other causes of infertility were asked to participate in the study.

Type of subfertility: all women had been suffering from infertility for at least 1 year (range: 1 to 5 years); no further clarification on primary versus secondary subfertility

Mean age: the mean age in the patients with submucous fibroids alone was 31.4 ± 2.5 years; the mean age in the patients with mixed submucous‐intramural fibroids was 32.2 ± 2.5 years

N recruited = 193 women

N participants = 181 women

N participants with submucous fibroids only = 52 women

N participants with mixed submucous‐intramural fibroids = 42 women

Inclusion criteria: age ≤ 35 years; infertility for at least 1 year; presence of one knot and/or fibroid of diameter ≤ 40 mm and absence of other causes of infertility at the performed examinations

Exclusion criteria: presence of 2 or more knots and/or fibroids of diameter > 40 mm; body weight > 20% of normal weight; and use of medication containing oestrogens, progestins or androgens within 8 weeks prior to the study

Duration of the study: 86 months; the study was conducted from January 1998 until April 2005

Interventions

Two interventions were compared:

  • The intervention group was treated with hysteroscopic surgery to remove the fibroids (n = 52)

  • The control group was not treated (n = 42)

Patients were examined by TVUS 3 months after surgery for control.

Patients who did not undergo surgery were asked to immediately start having regular fertility‐oriented intercourse (intercourse during the 6‐day fertile interval ending on the day of ovulation). Patients who underwent surgery were suggested to abstain from having sexual intercourse for 3 months and then to start having regular fertility‐oriented intercourse.

Patients were monitored for up to 12 months after study commencement.

Outcomes

A clinical pregnancy was defined by the visualisation of an embryo with cardiac activity at 6 to 7 weeks of pregnancy

Miscarriage was classified as clinical loss of an intrauterine pregnancy between the 7th and 12th weeks of gestation

Notes

The authors state that the differences in pregnancy rates between the comparison groups are statistically significant for the patients with submucous fibroids (P < 0.05), which is in contrast with the calculation of the results in RevMan.

The definition of knot is unclear: it could not be clarified since we failed to contact the study authors.

It is not clear whether a hysteroscopy was done in all women to confirm the exact position of the ultrasonically detected fibroids.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "Subsequently, women of each group were randomized into two subgroups, according to a randomisation table"

Comment: low risk of selection bias related to random sequence generation

Allocation concealment (selection bias)

Unclear risk

Method not stated: no further clarification obtained from the study authors

Comment: unclear risk of selection bias related to allocation concealment

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Method not stated: no further clarification obtained from the study authors

Comment: unclear risk of performance bias

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Method not stated: no further clarification obtained from the study authors

Comment: unclear risk of detection bias

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Quote: "One hundred and ninety‐three patients were diagnosed as affected by uterine fibroid excluding all other causes of infertility and met the requirements of the inclusion and exclusion criteria. Of these, 181 decided to participate in the study. Among the 181 patients, 52 had submucosal fibroids (SM group) while 45 had intramural fibroids (IM group), 11 had subserosal fibroids (SS group), 42 had a mix of submucosal–intramural (SM‐IM group) and 31 patients had a mix of intramural–subserosal fibroids (IM‐SS group)".

Quote: "Out of 181 women, 68 become pregnant"

Comment: low risk for attrition bias

Selective reporting (reporting bias)

High risk

The published report fails to include results for the live birth rate, which is the primary outcome of interest that would be expected to have been reported for a trial on fertility treatment conducted over a 7‐year period.

Other bias

Unclear risk

The mean ages and duration of infertility in the intervention and control group of women with submucous fibroids are not reported. No further clarification by the authors was obtained.

It is unclear whether there might have been imbalance in the baseline characteristics between the comparison groups.

Failure to do a hysteroscopy in all women to confirm the position of the ultrasonically detected fibroids could have caused information bias.

Pérez‐Medina 2005

Methods

Parallel‐group, randomised, controlled, single‐centre trial

A power analysis was performed. To detect an expected difference in pregnancy rate between the intervention and control group of 15% at a level of 0.05 with a power of 80%, a sample size of 200 women (i.e. 100 women per group) was required. From 2800 women attending the centre, 452 women fulfilling the inclusion criteria were selected; 215 women were randomised (107 women in the intervention group and 108 women in the control group). Data on outcomes of 204 women were available for analysis (101 in the intervention group and 103 in the control group). This study had therefore adequate statistical power to detect a difference between the comparison groups if really present.

Approved by the hospital's ethics committee

No source of funding or conflict of interest reported

Participants

Country: Spain

Setting: infertility unit of an university tertiary hospital in the Spanish capital Madrid

Population: women with unexplained, male or female factor infertility for at least 24 months bound to undergo intrauterine insemination with a sonographic diagnosis of endometrial polyps

Unexplained infertility was diagnosed in patients with normal ovulatory cycles, semen analysis, HSG and postcoital testing. Male factor infertility was diagnosed if 2 semen analyses obtained at least 1 month apart were subnormal according to the WHO criteria. Female factor infertility was diagnosed in patients with ovulatory dysfunction, cervical factor or endometriosis.

Type of subfertility: primary subfertility (correspondence with the study authors)

Mean age: treatment group = 30.8 years (26.7 to 34.9), control group = 30.9 years (26.5 to 35.3)

N recruited = 452 women

N randomised = 215 women

Inclusion criteria: women with at least 24 months of subfertility with a sonographic diagnosis of endometrial polyps bound to undergo intrauterine insemination for unexplained, male or female factor infertility
Exclusion criteria: women > 39 years of age, anovulation, azoospermia, uncorrected tubal disease or previous unsuccessful use of recombinant FSH

Duration of the study: 50 months; the study was conducted from January 2000 to February 2004

Interventions

One surgeon (the first author of the study TP‐M) performed all hysteroscopic procedures by intention in an outpatient office setting under local anaesthesia

Two interventions were compared:

  • Hysteroscopic polypectomy using a 5.5 mm continuous flow office hysteroscope with a 1.5 mm scissors and forceps (n = 107)

  • Diagnostic hysteroscopy using a 5.5 mm continuous flow office hysteroscope and polyp biopsy (n = 108)

Duration: women were scheduled to receive 4 cycles of IUI with subcutaneous injection of recombinant FSH 50 IU daily from the third day, and the first IUI was planned for 3 cycles after hysteroscopy in both groups. 4 IUI cycles were attempted before finishing the trial.

Outcomes

Primary: Quote: "We studied the crude pregnancy rate in both groups"

Comment: clinical pregnancy; crude pregnancy was defined by the study authors as follows: "the presence of a gestational sac on ultrasound" (correspondence with the study authors)
Secondary: time‐to‐pregnancy and influence of the size of the endometrial polyps on the pregnancy rate

Notes

1. Quote: "Patients underwent a complete infertility evaluation that included TVUS in the early proliferative phase, basal body temperature recording to assess ovulation, postcoital test (PCT), HSG, semen analysis and, in some patients, diagnostic laparoscopy"

Comment: according to correspondence with the first author, the aim of the laparoscopy was exclusively diagnostic in the evaluation of cases of unexplained infertility of unknown origin. If tubal pathology was detected by laparoscopy, the patient was excluded from randomisation. The numbers of women undergoing a laparoscopy were balanced between the 2 comparison groups.

2. In this study IUI was performed for various indications: male factor (21%), cervical factor (11%), endometriosis (11%), or unexplained subfertility (49%) and ovulation disorder (33%). Anovulation is reported in the methods section as an exclusion criterion. The study authors defined ovulation disorder as follows: Quote: "A combination of irregular menstrual cycles with multicystic ovaries on TVUS and basal gonadotrophin measurements within the normal range" (correspondence with the first study author). Comment: In everyday clinical practice ovulation disorder is not an indication for IUI by itself.

3. Data on the number or the localisation of the polyps could not be retrieved since the first author no longer works in the university hospital.

4. Data on the size of the polyps in the control group could not be obtained for similar reasons as footnote 3.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "Patients were randomised to one of the two groups with use of an opaque envelope technique, with assignment determined by a computerized random number table"

Quote: "Subjects were randomised into one of two groups in a 1:1 ratio using a restricted randomisation"

Comment: probably done, but using simple randomisation, with an equal allocation ratio, by referring to a table of random numbers generated by a computer

Allocation concealment (selection bias)

Low risk

Quote: "Patients were randomised to one of the two groups with use of an opaque envelope technique, with assignment determined by a computerized random number table".

Comment: sequentially numbered, opaque, sealed envelopes were used according to correspondence with the first author; probably done

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Method not stated: no further clarification obtained from the study authors

Comment: unclear risk of performance bias

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Method not stated: no further clarification obtained from the study authors

Comment: unclear risk of detection bias

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Quote: "11 patients were lost from the study, 6 in the study group (3 lost to follow‐up, 2 pathologic reports of submucosal myoma and 1 in whom the polyp was not confirmed) and 5 in the control group (1 lost to follow‐up, 2 in whom the polyp was not confirmed and 2 pathologic reports of myoma)"

Comment: missing outcome data are balanced in numbers across the comparison groups, with similar reasons for missing data across groups

Selective reporting (reporting bias)

High risk

Although the published report includes results on all the outcomes specified in the methods section, it nevertheless fails to include results for the live birth rate, which is the primary outcome of interest that would be expected to have been reported for a trial on fertility treatment conducted over a 4‐year period. Data on the outcomes live birth and miscarriage were not available since most the majority of randomised women were referred by gynaecologists from outside the tertiary university hospital and were referred back when pregnant for further follow‐up by the referring gynaecologist. No clarification could be obtained for the lack of data on hysteroscopic complications.

Other bias

Low risk

No evidence for imbalance in the baseline characteristics

FSH: follicle‐stimulating hormone
HSG: hysterosalpingography
IU: international units
IUI: intrauterine insemination
TVUS: transvaginal ultrasound
WHO: World Health Organization

Characteristics of excluded studies [ordered by study ID]

Study

Reason for exclusion

Abu Rafea 2013

Not addressing the research questions described in the protocol.

Parallel‐group randomised trial comparing intrauterine balloon stenting versus no stenting following hysteroscopic treatment for septate uterus.

Acunzo 2003

Not addressing the research questions described in the protocol.

Parallel‐group randomised trial studying the efficacy of hyaluronic acid gel in preventing the development of intrauterine adhesions following hysteroscopic adhesiolysis. Mixed population of women with intrauterine adhesions, presenting with subfertility or other gynaecological complaints. Primary outcome: adhesion scores.

Aghahosseini 2012

Not addressing the research questions described in the protocol.

Parallel‐group randomised trial comparing hysteroscopy prior to a subsequent IVF attempt versus immediate IVF without prior hysteroscopy conducted in patients with 2 or more failed IVF cycles with unsuspected or no uterine cavity abnormalities. Main outcomes: biochemical pregnancy, clinical pregnancy and delivery rates.

Amer 2010

Not addressing the research questions described in the protocol.

Parallel‐group randomised trial in subfertile women comparing the application of amnion graft, either fresh or dried to an intrauterine balloon versus the application of an intrauterine balloon without amnion graft as an adjunctive procedure after the hysteroscopic lysis of severe intrauterine adhesions, diagnosed at office hysteroscopy in women with infertility with or without menstrual disorders as the primary symptom. Outcomes assessed were improvement in adhesion grade, improvement in menstruation, increased uterine length at sounding, complications and reproductive outcome.

Colacurci 2007

Not addressing the research questions described in the protocol.

Parallel‐group randomised trial comparing two different surgical techniques for metroplasty: operative hysteroscopy using the resectoscope with a unipolar knife versus the Versapoint device. Mixed population of women with septate uterus and a history of recurrent miscarriage or primary subfertility. Outcomes assessed were operative parameters, complications, need for a second intervention and reproductive outcome parameters.

Darwish 2008

Not addressing the research questions described in the protocol.

Parallel‐group randomised trial comparing extended sectioning by resectoscopy versus sequential cold knife excision for treating a complete utero‐cervicovaginal septum in a mixed population of women suffering from infertility or pregnancy loss. Main outcome measures: operating time, perioperative bleeding, complications, reproductive outcome, and patient and husband satisfaction.

De Angelis 2010

Study on the effectiveness of hysteroscopic metroplasty for small septate uterus in women with repeated IVF implantation failure. Although denoted by the authors as the first prospective randomised controlled study on this subject, the trial did not use a valid random sequence generation.

Quote: "These patients, once informed about the situation, were randomly allocated, depending on their personal decision ...".

De Iaco 2003

Not addressing the research questions described in the protocol.

Parallel‐group randomised trial comparing the application of hyaluronan derivative gel (Hyalobarrier® gel) after hysteroscopic surgery versus surgical treatment alone in women aged 18 to 65 years, suffering from other gynaecological conditions than subfertility. Primary outcome: adhesion score at second look hysteroscopy.

Demirol 2004

Not addressing the research questions described in the protocol.

Parallel‐group randomised comparison between office hysteroscopy prior to a subsequent IVF attempt or immediate IVF without prior office hysteroscopy conducted in patients with 2 or more failed IVF cycles with unsuspected or no uterine cavity abnormalities. Outcome measures: number of oocytes retrieved, fertilisation rate, number of embryos transferred, first trimester miscarriage and clinical pregnancy rates.

Di Spiezio Sardo 2011

Not addressing the research questions described in the protocol.

Parallel‐group randomised trial comparing the use of Intercoat® absorbable adhesion barrier gel versus no adhesion barrier after hysteroscopic synechiolysis in a mixed population of women suffering from infertility or other gynaecological conditions. Primary outcome: incidence of de novo intrauterine adhesions, adhesion scores, patency of the internal uterine ostium.

El‐Nashar 2011

Not addressing the research questions described in the protocol.

Parallel‐group randomised trial comparing diagnostic hysteroscopy with directed biopsy and/or hysteroscopic treatment of unsuspected uterine cavity abnormalities versus no hysteroscopy in women with primary infertility treated with ICSI. Primary outcome: clinical pregnancy.

El‐Toukhy 2009

Not addressing the research questions described in the protocol.

Parallel‐group randomised trial comparing hysteroscopy versus no hysteroscopy in women with recurrent implantation failure with IVF.Status: completed.

Elsetohy 2015

Not addressing the research questions described in the protocol.

Parallel‐group randomised trial aimed at assessing the role of using the office hysteroscopy as a routine investigation in improving ICSI pregnancy rates in two groups of infertile women with no abnormality detected on transvaginal ultrasonographic examination

Fatemi 2007

Not addressing the PICO research question of this Cochrane review.

Gao 2013

Observational non‐randomised study on the effectiveness of hysteroscopy in women with repeated implantation failure.

Guida 2004

Not addressing the research questions described in the protocol.

Parallel‐group randomised trial comparing hysteroscopic surgery for the removal of polyps, fibroids or septa followed by the application of auto‐cross linked hyaluronic acid gel versus hysteroscopic surgery without the adhesion barrier in a mixed population of women with subfertility and other gynaecological symptoms associated with endometrial polyps, submucous fibroids or septa. Main outcomes: rates of adhesion formation and adhesion scores.

Lieng 2010a

Not addressing the research questions described in the protocol.

Parallel‐group randomised trial comparing transcervical resection by hysteroscopy of endometrial polyps suspected on TVUS and SIS versus observation for 6 months. The study population included premenopausal women with bleeding problems associated with endometrial polyps. The aim of the trial was to study the clinical effectiveness of transcervical resection of endometrial polyps for the outcome periodic blood loss. Women wishing to become pregnant were excluded from the trial. Primary outcome: periodic blood loss measured by the Pictorial Blood Assessment Chart.

Lin 2014

Not addressing the research questions described in the protocol.

Randomised trial comparing the efficacy of intrauterine balloon and intrauterine contraceptive device in the prevention of adhesion reformation following hysteroscopic adhesiolysis.

Mohammed 2014

Comparative non‐randomised study on the value of hysteroscopy prior to IVF/ICSI.

Muzii 2007

Not addressing the research questions described in the protocol.

Parallel‐group randomised trial in women aged 18 to 75 years comparing operative hysteroscopy using the monopolar resectoscope versus hysteroscopic bipolar electrode excision for the treatment of endometrial polyps. Outcomes: operating times, difficulty of the operation, surgeon satisfaction with the procedure, complications, postoperative pain and patient satisfaction.

Pabuccu 2008

Quasi‐randomised trial comparing early second look office hysteroscopic adhesiolysis after hysteroscopic adhesiolysis and IUD insertion versus no early second look operative hysteroscopy in subfertile women with intrauterine adhesions. The method of sequence generation is based on alternation: women were allocated to the intervention or control groups based on their study entry.

Main outcomes: pregnancy and live birth rate.

Pansky 2009

Not addressing the research questions described in the protocol.

Parallel‐group randomised trial studying the effectiveness of an anti‐adhesion barrier gel in women treated by operative hysteroscopy for retained products of conception. Status:completed.

Parsanezhad 2006

Not addressing the research questions described in the protocol.

Parallel‐group randomised trial in a mixed study population of women with a history of pregnancy wastage or infertility and an associated complete uterine septum comparing metroplasty with complete section of the cervical septum versus metroplasty with preservation of the cervical septum. Outcome measures: operating time, distending media deficit, total distending media used, intraoperative bleeding, complications and reproductive outcome.

Rama Raju 2006

Not addressing the research questions described in the protocol.

Parallel‐group randomised trial conducted in patients with 2 or more failed IVF cycles with unsuspected or no uterine cavity abnormalities comparing office hysteroscopy prior to a subsequent IVF attempt or immediate IVF without prior hysteroscopy. Outcomes: number of oocytes retrieved, fertilisation rate, number of embryos transferred and clinical pregnancy rates.

Shawki 2010

Not addressing the research questions described in the protocol.

Parallel‐group randomised trial conducted to determine the incidence of unsuspected uterine cavity abnormalities detected by office hysteroscopy in patients before ICSI treatment compared to ICSI without prior hysteroscopy. Main outcomes were the incidence of unsuspected uterine abnormalities and implantation and clinical pregnancy rates.

Shokeir 2010

Published report describing a parallel‐group randomised trial comparing hysteroscopic myomectomy versus diagnostic hysteroscopy and biopsy in women with otherwise unexplained primary infertility and submucous fibroids. Primary outcome: clinical pregnancy rates.

Quote from Fertility and Sterility searched on 16 January 2012: "This article has been retracted at the request of the editor as it duplicates parts of a paper that had already appeared in Hum. Reprod., 20 (2005) 1632–1635, DOI:10.1093/humrep/deh822".

Tonguc 2008

Not addressing the research questions described in the protocol.

Parallel‐group randomised comparing hysteroscopic lysis of intrauterine adhesions with or without adjunctive therapy (cyclical hormone replacement therapy alone or intrauterine device alone or both co‐treatments combined) after hysteroscopic metroplasty in a mixed population of women with subfertility and/or recurrent miscarriage. Main outcomes: incidence of de novo adhesion formation and ongoing pregnancy rate.

Trninić‐Pjević 2011

Clinical controlled trial on the effectiveness of hysteroscopy prior to IVF; no random sequence generation.

van Dongen 2008

Not addressing the research questions described in the protocol.

Parallel‐group randomised trial comparing the hysteroscopic removal of polyps or fibroids by conventional hysteroscopy using a resectoscope versus hysteroscopic morcellation in a mixed population of women suffering from infertility or other gynaecological conditions. Outcome measures: mean number of insertions into the uterine cavity and mean operating time.

Vercellini 1993

Not addressing the research questions described in the protocol.

Parallel‐group randomised comparing metroplasty using the resectoscope versus micro scissors for treating uterine septum in women with repeated miscarriage. Outcome measures: mean operating time, mean amount of distension medium used and complications.

Youssef 2013

Not addressing the research questions described in the protocol.

Parallel‐group randomised trial comparing 2 different surgical techniques for metroplasty: resectoscopy with monopolar knife versus small‐diameter hysteroscopy fitted with a 5 Fr reusable bipolar electrode.Outcomes measures included pregnancy, miscarriage and live birth rates.

ICSI: intracytoplasmic sperm injection
IUD: intrauterine device
IVF: in vitro fertilisation
PICO: Participants, Interventions, Comparisons and Outcomes
SIS: saline infusion sonography
TVUS: transvaginal ultrasound

Characteristics of studies awaiting assessment [ordered by study ID]

Clark 2014

Methods

Randomised controlled multi‐centre equivalence trial

Participants

Abnormal uterine bleeding associated with a benign polyp.

Inclusion criteria:

1. Abnormal uterine bleeding requiring diagnostic micro‐hysteroscopy
2. Finding of a benign polyp (glandulocystic or pedunculated/grade 0 fibroid) on diagnostic micro‐hysteroscopy
3. No hysteroscopic features suspicious of malignancy
4. Need for polypectomy

Exclusion criteria:

1. Hysteroscopic features suggesting malignant lesion
2. Additional pathology necessitating hysterectomy

Interventions

Outpatient polypectomy will be performed immediately following diagnosis at outpatient hysteroscopy in most instances, although some participants may have their outpatient treatment scheduled to a later date, depending upon local circumstances, within the following 8 weeks, as not all clinics are able to offer immediate “see & treat” outpatient treatment. Polyp removal will be carried out under direct hysteroscopic vision using miniature mechanical or electrosurgical instruments, with or without the need for minor degrees of cervical dilatation and local anaesthesia (direct cervical infiltration or paracervical injection). Occasionally blind avulsion with small polypectomy forceps after hysteroscopic localisation may be required.

Inpatient polypectomy will be performed within 8 weeks of the initial diagnosis at outpatient hysteroscopy. Inpatient polypectomy will be performed by traditional dilatation and endometrial curettage ('D&C'), blind avulsion with or without prior localising hysteroscopy or under direct vision using an operative hysteroscope. In most instances, wide dilation of the cervical canal will be required to accommodate the larger diameter inpatient instruments within the uterus. General or spinal anaesthesia facilitates major degrees of cervical dilatation and manipulation of these larger diameter instruments within the uterine cavity.

Outcomes

Primary outcome: The patient's own assessment of bleeding symptoms at 6 months, using a dichotomous outcome measure, will be used to establish if the treatment has been successful.

Secondary outcome: The following secondary outcomes will be assessed by a booklet sent to the women at home containing questionnaires/questions at baseline, 6, 12 and 24 months post‐randomisation:
1. Shaw Menorrhagia assessment scale A multi‐attribute utility, designed to measure the impact of heavy menstrual bleeding (menorrhagia) upon HRQL
2. Likert scale. All patients will be asked how their bleeding has responded to treatment using a Likert scale with four response options
3. Health‐related quality of life measured by EuroQol EQ‐5D Instrument
4. Visual analogue scale (VAS) It is now well established that objective measures of blood loss are not particularly relevant to women’s subjective perception of bleeding symptoms

Notes

Status of the trial: completed.

Query clarified by Dr Justin Clark on 08‐12‐2014:

"Our paper is just undergoing revision and should be published in the BMJ early next year.

Our full NIHR HTA report will be published shortly afterwards – publication being held until the BMJ paper is in.

I am unaware of any similar trials in female infertility – only MH Emanuel septoplasty trial and Dick Schoot RPOC morcellation study".

Moramezi 2012

Methods

Randomisation: randomised; blinding: not blinded; placebo: not used; assignment: parallel

Participants

Infertile patients aged 20 to 40 years who are candidates for IUI with normal hysterosalpingography

Exclusion criterion: ovarian hyperstimulation syndrome in patients suffering complications during surgery and hysteroscopy

Interventions

Intervention group: hysteroscopy

Control group: no hysteroscopy

Outcomes

Primary outcome: pregnancy, diagnosed by ultrasound at 2 months after intervention

Secondary outcome: complications of hysteroscopy and treatment side effects of ovulation induction

Notes

Recruitment status: completed.

The primary study author will be contacted.

HRQL: health‐related quality of life
IUI: intrauterine insemination

Characteristics of ongoing studies [ordered by study ID]

Abiri 2014

Trial name or title

The effect of hysteroscopy on successful pregnancy in IVF in the infertile women who are candidate for the first IVF cycle

Methods

Parallel‐group randomised controlled trial

Participants

Inclusion criteria: age less than 38 years; BMI > 35, did not undergo hysteroscopy in the two past months, absence of uterine and tubal pathology which is incurable by hysteroscopy, couples undergoing ART with their own gametes.

Exclusion criteria: embryo Donation, oocyte donation, TESE, hypothalamic amenorrhoea, OHSS, severe male factor, BMI < 35, hysteroscopy in past two months, age equal or more than 38 years, prior history of IVF, uterine and tubal pathology which is incurable by hysteroscopy.

Interventions

Intervention 1: In the control group: no intervention will be done. Intervention 2: In the intervention group, hysteroscopy is performed within 14 days prior to in vitro fertilisation and If there is an abnormality in the uterine cavity, this will be correct at the same time.

Outcomes

Primary outcome: biochemical pregnancy. Timepoint: 2 weeks after IVF. Method of measurement: ßHCG.

Secondary outcome:clinical pregnancy. Timepoint: 4 weeks after IVF. Method of measurement: vaginal sonography.

Starting date

24 May 2014

Contact information

Amene Abiri

Infertility department, second floor, Shariati Hospital, Jalal al Ahmad avenue, Tehran

14114, Islamic Republic of Iran

Telephone: 00982184902421

e‐mail: abiriir@ yahoo.com

Notes

Recruitment status: completed.

Basma 2013

Trial name or title

Hysteroscopy before first trial ICSI

Methods

Parallel‐group randomised controlled trial

Participants

Primary infertility

Inclusion criteria: No previous IVF/ICSI cycle

Exclusion criteria: Antral follicle count (AFC) 4, Anti‐mullarian hormone (AMH) `0.7, detectable uterine pathology by ultrasound

Age minimum: 20 years
Age maximum: 40 years
Gender: Female

Interventions

Not reported in the registered study protocol

Outcomes

Primary outcome: clinical pregnancy with cardiac pulsation

Secondary outcome: abortion, implantation rate

Starting date

01 June 2013

Contact information

Elsayedamr Basma

30 Garden City Smouha, Alexandria, Egypt

Telephone: 00201223106023

e‐mail: [email protected]

Notes

Broekmans 2010

Trial name or title

SIGnificance of Routine Hysteroscopy Prior to a First 'in Vitro Fertilization' (IVF) Treatment Cycle ‐ inSIGHT

ClinicalTrials.gov NCT01242852

Methods

Multicentre, single‐blind, parallel‐group randomised controlled trial

Participants

Women with primary or secondary infertility due to undergo IVF treatment with normal transvaginal ultrasound in the follicular phase of the menstrual cycle

Interventions

Office hysteroscopy combined with a saline infusion sonography prior to a first IVF cycle compared to starting IVF without prior hysteroscopy

Outcomes

Primary: ongoing pregnancy

Secondary: costs, implantation rate, miscarriage rate and patient tolerance

Starting date

Current status on 1 November 2012: recruiting

Contact information

F.J. Broekmans, M.D., PhD

University Medical Center Utrecht, Utrecht the Netherlands 3584CX

Telephone:  +31 887551041
e‐mail: [email protected]

Notes

El‐Khayat 2012

Trial name or title

Does office hysteroscopy and endometrial snip improve IUI outcome?: a randomized controlled trial

Methods

Allocation: randomised; endpoint classification: efficacy study; intervention model: parallel assignment; masking: single‐blind (participant); primary purpose: treatment

Participants

Inclusion criteria: 18 to 38 years old, at least 1 patent tube, unexplained infertility or anovulation or mild to moderate male factor infertility, previous failed IUI
Exclusion criteria: indication for ICSI

Interventions

Control group: office hysteroscopy

Intervention group: office hysteroscopy and endometrial snip

Outcomes

Primary outcome: clinical pregnancy rate at 10 months

Secondary outcome: ongoing pregnancy rate at 12 months

Starting date

Current status on 1 November 2012: recruiting since February 2012

Contact information

Waleed El‐Khayat, MD

Faculty of Medicine, Cairo University

Telephone: 23655215
e‐mail: [email protected]

Notes

Status: recruiting.

Hare 2013

Trial name or title

Hysteroscopy before in vitro fertilization ‐ Does it improve the outcome?

Methods

Parallel group randomised trial

Participants

Inclusion Criteria: Women submitted to IVF or ISCI treatment, age > 18 years,able to read, speak and understand Danish, written consent.
Exclusion Criteria: intrauterine abnormalities, infection, BMI > 35, known intrauterine cause to the infertile condition,abuse of alcohol or drugs,untreated medical condition, pregnancy.

Age minimum: 18 years
Age maximum: 40 years
Gender: Female

Interventions

Office‐hysteroscopy with biopsy

Outcomes

pregnancy rates

[Time Frame: individual outcome will be evaluated within 8 weeks after IVF treatment. Over all outcome will be evaluated after 3 years.]

Starting date

January 2013

Contact information

Kristine Juul Hare, MD, PhD

Hvidovre University Hospital, Danmark

e‐mail: [email protected]

Notes

Recruiting.

Revel 2011

Trial name or title

Safety study of use of hyaluronic acid gel to prevent intrauterine adhesions in hysteroscopic surgery

Methods

Single‐centre, parallel‐group, randomised, single‐blind controlled trial

Participants

Women 18 years of age or older, undergoing hysteroscopic treatment

Interventions

Application of hyaluronic acid gel (study group); the control intervention is not described

Outcomes

Patient satisfaction following gel application at 2 months

Starting date

Current status on 1 November 2012: not yet recruiting

Contact information

Ariel Revel, MD

Hadassah Medical Organization

Telephone: 97226777111 ext 76389

e‐mail: [email protected]

Notes

Sohrabvand 2012

Trial name or title

Evaluation of diagnostic hysteroscopy findings in patients candidate for ART (IVF, ICSI) and its effect on pregnancy rate compared to control group

Methods

Randomisation: randomised; blinding: not blinded; placebo: not used; assignment: parallel; purpose: treatment

Participants

Inclusion criteria: hysterosalpingography normal during the past 12 months; normal vaginal ultrasound; age between 25 and 40 years; absence of abnormal uterine bleeding and no hysteroscopy performed in the last 6 months

Interventions

Control group: hysteroscopy is not done

In the intervention group a hysteroscopy is performed; submucosal myoma or polyps 1 cm or larger cervical or uterine adhesions will be resolved

Outcomes

Primary outcomes: presence of pathology

Secondary outcomes: pregnancy 14 days after embryo transfer

Starting date

Current status on 1 November 2012: recruiting since June 2012

Contact information

Farnaz Sohrabvand

Vali‐e‐Asr Reproductive Health & Research Center

Telephone: 00982166939320

e‐mail: [email protected]

Notes

Weiss 2005

Trial name or title

Endometrial hysteroscopy and curettage prior to embryo transfer

Methods

Parallel group randomised study

Participants

Inclusion Criteria: informed consent, in‐vitro fertilisation candidate, normal blood coagulation.
Exclusion Criteria: anaemia (haemoglobin < 10 mg/dL), abnormal maternal karyotype, thrombocytopenia < 140,000, any contraindication to hysteroscopy or in‐vitro fertilisation

Age minimum: 18 years
Age maximum: 35 years
Gender: Female

Interventions

Hysteroscopy and curettage

Outcomes

Primary outcomes: Endometrial receptivity, implantation rate and pregnancy rate

Starting date

December 2005

Contact information

Amir Weiss

HaEmek Medicak Center and Technion, Israel Institute of Technology

Telephone: 972‐4‐6494031

e‐mail: [email protected]

Notes

Status: recruiting.

The first author will be contacted.

ART: assisted reproductive technology
ßHCG: beta human chorionic gonadotropin
BMI: body mass index
ICSI: intracytoplasmic sperm injection
IUI: intrauterine insemination
IVF: in vitro fertilisation
OHSS: Ovarian hyperstimulation syndrome
TESE: Testicular sperm extraction

Data and analyses

Open in table viewer
Comparison 1. Operative hysteroscopy versus control in women with otherwise unexplained subfertility and suspected major uterine cavity abnormalities

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Clinical pregnancy Show forest plot

1

94

Odds Ratio (M‐H, Fixed, 95% CI)

2.44 [0.97, 6.17]

Analysis 1.1

Comparison 1 Operative hysteroscopy versus control in women with otherwise unexplained subfertility and suspected major uterine cavity abnormalities, Outcome 1 Clinical pregnancy.

Comparison 1 Operative hysteroscopy versus control in women with otherwise unexplained subfertility and suspected major uterine cavity abnormalities, Outcome 1 Clinical pregnancy.

1.1 Removal of submucous fibroids only vs regular fertility‐oriented intercourse

1

52

Odds Ratio (M‐H, Fixed, 95% CI)

2.04 [0.62, 6.66]

1.2 Removal of mixed submucous‐intramural fibroids vs regular fertility‐oriented intercourse

1

42

Odds Ratio (M‐H, Fixed, 95% CI)

3.24 [0.72, 14.57]

2 Miscarriage Show forest plot

1

30

Odds Ratio (M‐H, Fixed, 95% CI)

0.58 [0.12, 2.85]

Analysis 1.2

Comparison 1 Operative hysteroscopy versus control in women with otherwise unexplained subfertility and suspected major uterine cavity abnormalities, Outcome 2 Miscarriage.

Comparison 1 Operative hysteroscopy versus control in women with otherwise unexplained subfertility and suspected major uterine cavity abnormalities, Outcome 2 Miscarriage.

2.1 Removal of submucous fibroids only vs regular fertility‐oriented intercourse

1

19

Odds Ratio (M‐H, Fixed, 95% CI)

0.63 [0.09, 4.40]

2.2 Removal of mixed submucous‐intramural fibroids vs regular fertility‐oriented intercourse

1

11

Odds Ratio (M‐H, Fixed, 95% CI)

0.5 [0.03, 7.99]

Open in table viewer
Comparison 2. Operative hysteroscopy versus control in women undergoing MAR with suspected major uterine cavity abnormalities

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Clinical pregnancy Show forest plot

1

204

Odds Ratio (M‐H, Fixed, 95% CI)

4.41 [2.45, 7.96]

Analysis 2.1

Comparison 2 Operative hysteroscopy versus control in women undergoing MAR with suspected major uterine cavity abnormalities, Outcome 1 Clinical pregnancy.

Comparison 2 Operative hysteroscopy versus control in women undergoing MAR with suspected major uterine cavity abnormalities, Outcome 1 Clinical pregnancy.

1.1 Hysteroscopic polypectomy vs diagnostic hysteroscopy and biopsy only prior to IUI

1

204

Odds Ratio (M‐H, Fixed, 95% CI)

4.41 [2.45, 7.96]

PRISMA study flow diagram.
Figuras y tablas -
Figure 1

PRISMA study flow diagram.

'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.
Figuras y tablas -
Figure 2

'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.

'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Figuras y tablas -
Figure 3

'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

Forest plot of comparison: 1 Hysteroscopic myomectomy vs regular fertility‐oriented intercourse in women with unexplained subfertility and submucous fibroids.Outcome: 1.1 Clinical pregnancy per woman randomised.
Figuras y tablas -
Figure 4

Forest plot of comparison: 1 Hysteroscopic myomectomy vs regular fertility‐oriented intercourse in women with unexplained subfertility and submucous fibroids.Outcome: 1.1 Clinical pregnancy per woman randomised.

Forest plot of comparison: 1 Hysteroscopic myomectomy vs regular fertility‐oriented intercourse in women with unexplained subfertility and submucous fibroids. Outcome: 1.2 Miscarriage per clinical pregnancy.
Figuras y tablas -
Figure 5

Forest plot of comparison: 1 Hysteroscopic myomectomy vs regular fertility‐oriented intercourse in women with unexplained subfertility and submucous fibroids. Outcome: 1.2 Miscarriage per clinical pregnancy.

Forest plot of comparison: 2 Hysteroscopic removal of polyps vs diagnostic hysteroscopy and biopsy only prior to IUI. Outcome: 2.1 Clinical pregnancy per woman randomised.
Figuras y tablas -
Figure 6

Forest plot of comparison: 2 Hysteroscopic removal of polyps vs diagnostic hysteroscopy and biopsy only prior to IUI. Outcome: 2.1 Clinical pregnancy per woman randomised.

Comparison 1 Operative hysteroscopy versus control in women with otherwise unexplained subfertility and suspected major uterine cavity abnormalities, Outcome 1 Clinical pregnancy.
Figuras y tablas -
Analysis 1.1

Comparison 1 Operative hysteroscopy versus control in women with otherwise unexplained subfertility and suspected major uterine cavity abnormalities, Outcome 1 Clinical pregnancy.

Comparison 1 Operative hysteroscopy versus control in women with otherwise unexplained subfertility and suspected major uterine cavity abnormalities, Outcome 2 Miscarriage.
Figuras y tablas -
Analysis 1.2

Comparison 1 Operative hysteroscopy versus control in women with otherwise unexplained subfertility and suspected major uterine cavity abnormalities, Outcome 2 Miscarriage.

Comparison 2 Operative hysteroscopy versus control in women undergoing MAR with suspected major uterine cavity abnormalities, Outcome 1 Clinical pregnancy.
Figuras y tablas -
Analysis 2.1

Comparison 2 Operative hysteroscopy versus control in women undergoing MAR with suspected major uterine cavity abnormalities, Outcome 1 Clinical pregnancy.

Summary of findings for the main comparison. Operative hysteroscopy compared with control for unexplained subfertility associated with suspected major uterine cavity abnormalities

Operative hysteroscopy compared with control for unexplained subfertility associated with suspected major uterine cavity abnormalities

Patient or population: women with submucous fibroids and otherwise unexplained subfertility

Settings: infertility centre in Rome, Italy

Intervention: hysteroscopic removal of one submucous fibroid ≤ 40 mm

Comparison: regular fertility‐oriented intercourse

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Control

Myomectomy

Live birth

No data were reported for this primary outcome.

Hysteroscopy complications

No data were reported for this primary outcome.

Clinical pregnancy

ultrasound1

12 months

Medium‐risk population

OR 2.44

(0.97 to 6.17)

94
(1 study)

⊕⊝⊝⊝
very low2,3,4

214 per 1000

399 per 1000
(209 to 627)

Miscarriage

ultrasound5

12 months

Medium‐risk population

OR 0.58

(0.12 to 2.8)

30 pregnancies in 94 women
(1 study)

⊕⊝⊝⊝
very low2,3,4

556 per 1000

421 per 1000
(131 to 778)

*The basis for the assumed risk is the control group risk of the single included study (Casini 2006). The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: confidence interval; OR: odds ratio

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

1 A clinical pregnancy was defined by the visualisation of an embryo with cardiac activity at six to seven weeks' gestational age.

2 Unclear allocation concealment.

3 Wide confidence intervals.

4 High risk of selective outcome reporting and unclear whether there is other bias caused by imbalance in the baseline characteristics.

5 Miscarriage was defined by the clinical loss of an intrauterine pregnancy between the 7th and 12th weeks of gestation.

Figuras y tablas -
Summary of findings for the main comparison. Operative hysteroscopy compared with control for unexplained subfertility associated with suspected major uterine cavity abnormalities
Summary of findings 2. Operative hysteroscopy compared with control for suspected major uterine cavity abnormalities prior to medically assisted reproduction

Operative hysteroscopy compared with control for suspected major uterine cavity abnormalities prior to medically assisted reproduction

Patient or population: subfertile women with endometrial polyps diagnosed by ultrasonography prior to treatment with gonadotropin and intrauterine insemination

Settings: infertility unit of a university tertiary hospital in the Spanish capital Madrid

Intervention: hysteroscopic polypectomy using a 5.5 mm continuous flow office hysteroscope with a 1.5 mm scissors and forceps

Comparison: diagnostic hysteroscopy using a 5.5 mm continuous flow office hysteroscope and polyp biopsy

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Control

Polypectomy

Live birth

No data were reported for this primary outcome.

Hysteroscopy complications

No data were reported for this primary outcome.

Clinical pregnancy

ultrasound1

4 IUI cycles

Low‐risk population2

OR 4.41

(2.45 to 7.96)

204
(1 study)

⊕⊕⊕⊝
moderate5

250 per 1000

595 per 1000
(450 to 726)

Medium‐risk population3

366 per 1000

718 per 1000
(586 to 821)

High‐risk population4

528 per 1000

831 per 1000
(733 to 899)

Miscarriage

No data were reported for this secondary outcome.

*The basis for the assumed risk in the low‐, medium‐ or high‐risk populations is the control group risk of three studies provided in the footnotes below. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: confidence interval; OR: odds ratio

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

1 Clinical pregnancy was defined by the presence of at least one gestational sac on ultrasound.

2 Based on the clinical pregnancy rate per woman after 4 cycles gonadotropins and IUI for male factor subfertility based on data from Bensdorp 2007.

3 Based on the clinical pregnancy rate per woman after 4 cycles gonadotropins and IUI for unexplained subfertility based on data from Veltman‐Verhulst 2012.

4 Based on the clinical pregnancy rate per woman after 4 cycles gonadotropins and IUI for female factor subfertility based on data from Spiessens 2003.

5 There was high risk for selective outcome reporting.

Figuras y tablas -
Summary of findings 2. Operative hysteroscopy compared with control for suspected major uterine cavity abnormalities prior to medically assisted reproduction
Table 1. Effect of polyp size on clinical pregnancy rates in the intervention group

Polyp size

Clinical pregnancy1

Clinical pregnancy rate (95% CI)2

< 5 mm

19/25

76% (from 72% to 80%)

5 to 10 mm

18/32

56% (from 53% to 59%)

11 to 20 mm

16/26

61% (from 58% to 65%)

> 20 mm

11/18

61% (from 58% to 64%)

1 Clinical pregnancy is defined by a pregnancy diagnosed by ultrasound visualisation of at least one gestational sac per woman randomised.

2 No significant difference was found for the clinical pregnancy rates between the 4 subgroups (P = 0.32).

Figuras y tablas -
Table 1. Effect of polyp size on clinical pregnancy rates in the intervention group
Table 2. GRADE evidence profile ‐ unexplained subfertility and submucous fibroids

Quality assessment

Submucous fibroids and unexplained subfertility

No of studies

Design

Limitations

Inconsistency

Indirectness

Imprecision

Other considerations

Clinical pregnancy (follow‐up 1 year; ultrasound1)

1

RCT

Serious2

No serious inconsistency

No serious indirectness

Serious3

Reporting bias4

Miscarriage (follow‐up 1 year; ultrasound5)

1

RCT

Serious2

No serious inconsistency

No serious indirectness

Serious3

Reporting bias4

1 A clinical pregnancy was defined by the visualisation of an embryo with cardiac activity at six to seven weeks' gestational age.

2 Unclear allocation concealment.

3 Wide confidence intervals.

4 High risk of selective outcome reporting and unclear whether there is other bias caused by imbalance in the baseline characteristics.

5 Miscarriage was defined by the clinical loss of an intrauterine pregnancy between the 7th and 12th weeks of gestation.

Figuras y tablas -
Table 2. GRADE evidence profile ‐ unexplained subfertility and submucous fibroids
Table 3. GRADE evidence profile ‐ endometrial polyps prior to IUI

Quality assessment

Endometrial polyps prior to gonadotropin and IUI treatment

No of studies

Design

Limitations

Inconsistency

Indirectness

Imprecision

Other considerations

Clinical pregnancy (follow‐up 4 IUI cycles; ultrasound1)

1

RCT

No serious limitations

No serious inconsistency

No serious indirectness

No serious imprecision

Selective outcome reporting2

1 Clinical pregnancy was defined by the presence of at least one gestational sac on ultrasound.

2 There was high risk for selective outcome reporting bias.

Figuras y tablas -
Table 3. GRADE evidence profile ‐ endometrial polyps prior to IUI
Comparison 1. Operative hysteroscopy versus control in women with otherwise unexplained subfertility and suspected major uterine cavity abnormalities

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Clinical pregnancy Show forest plot

1

94

Odds Ratio (M‐H, Fixed, 95% CI)

2.44 [0.97, 6.17]

1.1 Removal of submucous fibroids only vs regular fertility‐oriented intercourse

1

52

Odds Ratio (M‐H, Fixed, 95% CI)

2.04 [0.62, 6.66]

1.2 Removal of mixed submucous‐intramural fibroids vs regular fertility‐oriented intercourse

1

42

Odds Ratio (M‐H, Fixed, 95% CI)

3.24 [0.72, 14.57]

2 Miscarriage Show forest plot

1

30

Odds Ratio (M‐H, Fixed, 95% CI)

0.58 [0.12, 2.85]

2.1 Removal of submucous fibroids only vs regular fertility‐oriented intercourse

1

19

Odds Ratio (M‐H, Fixed, 95% CI)

0.63 [0.09, 4.40]

2.2 Removal of mixed submucous‐intramural fibroids vs regular fertility‐oriented intercourse

1

11

Odds Ratio (M‐H, Fixed, 95% CI)

0.5 [0.03, 7.99]

Figuras y tablas -
Comparison 1. Operative hysteroscopy versus control in women with otherwise unexplained subfertility and suspected major uterine cavity abnormalities
Comparison 2. Operative hysteroscopy versus control in women undergoing MAR with suspected major uterine cavity abnormalities

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Clinical pregnancy Show forest plot

1

204

Odds Ratio (M‐H, Fixed, 95% CI)

4.41 [2.45, 7.96]

1.1 Hysteroscopic polypectomy vs diagnostic hysteroscopy and biopsy only prior to IUI

1

204

Odds Ratio (M‐H, Fixed, 95% CI)

4.41 [2.45, 7.96]

Figuras y tablas -
Comparison 2. Operative hysteroscopy versus control in women undergoing MAR with suspected major uterine cavity abnormalities