Hysteroscopy for treating subfertility associated with suspected major uterine cavity abnormalities

Jan Bosteels; Jenneke Kasius; Steven Weyers; Frank J Broekmans; Ben Willem J Mol; Thomas M D'Hooghe

doi:10.1002/14651858.CD009461.pub3

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Figure 1

PRISMA study flow diagram.

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Figure 2

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

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Figure 3

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

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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.

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Figure 5

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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.

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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.

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Analysis 1.2

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

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Analysis 2.1

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

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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 low^2,3,4
	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 low^2,3,4
	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 7^th and 12^th weeks of gestation.

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

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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.

Summary of findings 2. Operative hysteroscopy compared with control for suspected major uterine cavity abnormalities prior to medically assisted reproduction

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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).

Table 1. Effect of polyp size on clinical pregnancy rates in the intervention group

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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 7^th and 12^th weeks of gestation.

Table 2. GRADE evidence profile ‐ unexplained subfertility and submucous fibroids

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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.

Table 3. GRADE evidence profile ‐ endometrial polyps prior to IUI

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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]

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

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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]

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

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