Assisted reproductive technologies for male subfertility

Maartje Cissen; Alexandra Bensdorp; Ben J Cohlen; Sjoerd Repping; Jan Peter de Bruin; Madelon van Wely

doi:10.1002/14651858.CD000360.pub5

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Figure 1

Study flow diagram.

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Figure 2

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 3

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

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Figure 4

Forest plot of comparison: 1 Intra‐uterine insemination (IUI) versus timed intercourse (TI) both in natural cycles (NC), outcome: 1.1 Pregnancy rate per couple (all cycles).

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Figure 5

Forest plot of comparison: 2 Intra‐uterine insemination (IUI) versus timed intercourse (TI) both in cycles with ovarian hyperstimulation (OH), outcome: 2.3 Pregnancy rate per couple (all cycles).

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Figure 6

Forest plot of comparison: 4 Intra‐uterine insemination (IUI) in cycles with ovarian hyperstimulation (OH) versus timed intercourse (TI) in natural cycles (NC), outcome: 4.2 Pregnancy rate per couple (all cycles).

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Figure 7

Forest plot of comparison: 5 Intra‐uterine insemination (IUI) in natural cycles (NC) versus IUI in cycles with ovarian hyperstimulation (OH) versus IUI in natural cycles (NC), outcome: 5.2 Pregnancy rate per couple (all cycles).

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Figure 8

Forest plot of comparison: 8 In vitro fertilisation (IVF) versus intra‐uterine insemination (IUI) in natural cycles (NC), outcome: 8.1 Live birth rate per couple (all cycles).

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Figure 9

Forest plot of comparison: 9 In vitro fertilisation (IVF) versus intra‐uterine insemination (IUI) in cycles with ovarian hyperstimulation (OH), outcome: 9.1 Live birth rate per couple (all cycles).

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Analysis 1.1

Comparison 1 Intra‐uterine insemination (IUI) versus timed intercourse (TI) both in natural cycles (NC), Outcome 1 Pregnancy rate per couple (all cycles).

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Analysis 2.1

Comparison 2 Intra‐uterine insemination (IUI) versus timed intercourse (TI) both in cycles with ovarian hyperstimulation (OH), Outcome 1 Live birth rate per couple (all cycles).

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Analysis 2.2

Comparison 2 Intra‐uterine insemination (IUI) versus timed intercourse (TI) both in cycles with ovarian hyperstimulation (OH), Outcome 2 OHSS per couple.

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Analysis 2.3

Comparison 2 Intra‐uterine insemination (IUI) versus timed intercourse (TI) both in cycles with ovarian hyperstimulation (OH), Outcome 3 Pregnancy rate per couple (all cycles).

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Analysis 2.4

Comparison 2 Intra‐uterine insemination (IUI) versus timed intercourse (TI) both in cycles with ovarian hyperstimulation (OH), Outcome 4 Multiple pregnancy rate per couple.

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Analysis 2.5

Comparison 2 Intra‐uterine insemination (IUI) versus timed intercourse (TI) both in cycles with ovarian hyperstimulation (OH), Outcome 5 Miscarriage rate per couple.

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Analysis 4.1

Comparison 4 Intra‐uterine insemination (IUI) in cycles with ovarian hyperstimulation (OH) versus timed intercourse (TI) in natural cycles (NC), Outcome 1 Live birth rate per couple (all cycles).

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Analysis 4.2

Comparison 4 Intra‐uterine insemination (IUI) in cycles with ovarian hyperstimulation (OH) versus timed intercourse (TI) in natural cycles (NC), Outcome 2 Pregnancy rate per couple (all cycles).

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Analysis 5.1

Comparison 5 Intra‐uterine insemination (IUI) in cycles with ovarian hyperstimulation (OH) versus IUI in natural cycles (NC), Outcome 1 Live birth rate per couple (all cycles).

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Analysis 5.2

Comparison 5 Intra‐uterine insemination (IUI) in cycles with ovarian hyperstimulation (OH) versus IUI in natural cycles (NC), Outcome 2 Pregnancy rate per couple (all cycles).

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Analysis 5.3

Comparison 5 Intra‐uterine insemination (IUI) in cycles with ovarian hyperstimulation (OH) versus IUI in natural cycles (NC), Outcome 3 Miscarriage rate per couple.

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Analysis 8.1

Comparison 8 In vitro fertilisation (IVF) versus intra‐uterine insemination (IUI) in natural cycles (NC), Outcome 1 Live birth rate per couple (all cycles).

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Analysis 9.1

Comparison 9 In vitro fertilisation (IVF) versus intra‐uterine insemination (IUI) in cycles with ovarian hyperstimulation (OH), Outcome 1 Live birth rate per couple (all cycles).

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Analysis 9.2

Comparison 9 In vitro fertilisation (IVF) versus intra‐uterine insemination (IUI) in cycles with ovarian hyperstimulation (OH), Outcome 2 OHSS per couple.

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Analysis 9.3

Comparison 9 In vitro fertilisation (IVF) versus intra‐uterine insemination (IUI) in cycles with ovarian hyperstimulation (OH), Outcome 3 Pregnancy rate per couple (all cycles).

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Summary of findings for the main comparison. IUI in natural cycles compared to TI in natural cycles for male subfertility

IUI in natural cycles compared to TI in natural cycles for male subfertility
Patient or population: couples with male subfertility Settings: single centre (Australia, Italy) Intervention: IUI in natural cycles Comparison: TI in natural cycles
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of couples (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	TI in natural cycles	IUI in natural cycles
Live birth rate	Not reported in any included studies				‐	‐
OHSS	Not reported in any included studies				‐	‐
Pregnancy rate per couple (all cycles) Follow‐up: 9‐12 months	0 per 1000	0 per 1000 (0 to 0)	OR 4.57 (0.21 to 101.61)	62 (2 studies)	⊕⊝⊝⊝ very low^1,2	‐
The basis for the assumed risk* was the median control group risk across studies. 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; IUI: intra‐uterine insemination; OHSS: ovarian hyperstimulation syndrome; OR: odds ratio; TI: timed intercourse.
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 Risk of bias was very serious: 1. Francavilla 2009, allocation concealment: high risk (on chronological basis), 2. Francavilla 2009, other bias: high risk (no stratification by diagnosis category of subfertility). ² There was very serious imprecision, with small sample sizes and very few events.

Summary of findings for the main comparison. IUI in natural cycles compared to TI in natural cycles for male subfertility

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Summary of findings 2. IUI in stimulated cycles compared to TI in stimulated cycles for male subfertility

IUI in stimulated cycles compared to TI in stimulated cycles for male subfertility
Patient or population: couples with male subfertility Settings: single centre (Greece, Italy, The Netherlands) Intervention: IUI in stimulated cycles Comparison: TI in stimulated cycles
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of couples (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	TI in stimulated cycles	IUI in stimulated cycles
Live birth rate per couple (all cycles) Follow‐up: 3 months	220 per 1000	200 per 1000 (78 to 421)	OR 0.89 (0.30 to 2.59)	81 (1 study)	⊕⊕⊝⊝ low¹	‐
OHSS per couple Follow‐up: 6 months	See comment	See comment	Not estimable	59 (1 study)	⊕⊕⊝⊝ low¹	‐
Pregnancy rate per couple (all cycles) Follow‐up: 3‐6 months	175 per 1000	243 per 1000 (136 to 395)	OR 1.51 (0.74 to 3.07)	202 (3 studies)	⊕⊝⊝⊝ very low^1,2	‐
Multiple pregnancy rate per couple Follow‐up: 3 months	0 per 1000	0 per 1000 (0 to 0)	OR 3.15 (0.12 to 79.69)	81 (1 study)	⊕⊕⊝⊝ low³	‐
Miscarriage rate per couple Follow‐up: 3 months	73 per 1000	75 per 1000 (15 to 300)	OR 1.03 (0.19 to 5.42)	81 (1 study)	⊕⊕⊝⊝ low³	‐
The basis for the assumed risk* was the median control group risk across studies. 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; IUI: intra‐uterine insemination; OHSS: ovarian hyperstimulation syndrome; OR: odds ratio; TI: timed intercourse.
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 There was very serious imprecision, with small sample size. ² Inconsistency was serious between Melis 1995 (favoured TI + OH) and Gregoriou 1996 and Nan 1994 (favoured IUI + OH). ³ There was very serious imprecision, with small sample sizes and findings were compatible with substantial benefit in either group.

Summary of findings 2. IUI in stimulated cycles compared to TI in stimulated cycles for male subfertility

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Summary of findings 3. IUI in stimulated cycles compared to TI in natural cycles for male subfertility

IUI in stimulated cycles compared to TI in natural cycles for male subfertility
Patient or population: couples with male subfertility Settings: single centre (Italy) Intervention: IUI in stimulated cycles Comparison: TI in natural cycles
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of couples (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	TI in natural cycles	IUI in stimulated cycles
Live birth rate per couple (all cycles) Follow‐up: 9 months	0 per 1000	0 per 1000 (0 to 0)	OR 3.14 (0.12 to 81.35)	44 (1 study)	⊕⊝⊝⊝ very low^1,2	‐
OHSS	Not reported in any included studies					‐
Pregnancy rate per couple (all cycles) Follow‐up: 9 months	0 per 1000	0 per 1000 (0 to 0)	OR 3.14 (0.12 to 81.35)	44 (1 study)	⊕⊝⊝⊝ very low^1,2	‐
The basis for the assumed risk* was the median control group risk across studies. 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; IUI: intra‐uterine insemination; OHSS: ovarian hyperstimulation syndrome; OR: odds ratio; TI: timed intercourse.
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 Risk of bias was very serious: 1. Allocation concealment: high risk (on chronological basis), 2. Other bias: high risk (no stratification by diagnosis category of subfertility). ² There was very serious imprecision, with small sample sizes and very few events.

Summary of findings 3. IUI in stimulated cycles compared to TI in natural cycles for male subfertility

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Summary of findings 4. IUI in stimulated cycles compared to IUI in natural cycles for male subfertility

IUI in stimulated cycles compared to IUI in natural cycles for male subfertility
Patient or population: couples with male subfertility Settings: single and multicentre (Italy, the Netherlands, USA) Intervention: IUI in stimulated cycles Comparison: IUI in natural cycles
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of couples (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	IUI in natural cycles	IUI in stimulated cycles
Live birth rate per couple (all cycles) Follow‐up: 6‐9 months	172 per 1000	218 per 1000 (138 to 326)	OR 1.34 (0.77 to 2.33)	346 (3 studies)	⊕⊝⊝⊝ very low^1,2,3	‐
OHSS	Not reported in any included studies				‐	‐
Pregnancy rate per couple (all cycles) Follow‐up: 4‐9 months	148 per 1000	226 per 1000 (148 to 329)	OR 1.68 (1.00 to 2.82)	399 (4 studies)	⊕⊝⊝⊝ very low^1,3,4	‐
Miscarriage rate per couple Follow‐up: 6‐9 months	53 per 1000	56 per 1000 (11 to 238)	OR 1.06 (0.20 to 5.63)	115 (2 studies)	⊕⊝⊝⊝ very low^5,6	‐
The basis for the assumed risk* was the median control group risk across studies. 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; IUI: intra‐uterine insemination; OHSS: ovarian hyperstimulation syndrome; 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 Risk of bias was very serious: 1. Francavilla 2009, allocation concealment: high risk (on chronological basis), 2. Arici 1994, Francavilla 2009, and Guzick 1999, other bias: high risk (no stratification by diagnosis category of subfertility. ² Inconsistency was serious between Cohlen 1998a and Goverde 2000 (favoured IUI in natural cycles) and Arici 1994, Francavilla 2009, and Guzick 1999 (favoured IUI in stimulated cycles). ³ There was serious imprecision, with small sample sizes. ⁴ Inconsistency was serious between Cohlen 1998a (favoured IUI in natural cycles) and Arici 1994, Francavilla 2009, and Guzick 1999 (favoured IUI in stimulated cycles). ⁵ Risk of bias was very serious: Francavilla 2009, allocation concealment: high risk (on chronological basis) and other bias: high risk (no stratification by diagnosis category of subfertility). ⁶ There was serious imprecision, findings were compatible with no benefit in either group.

Summary of findings 4. IUI in stimulated cycles compared to IUI in natural cycles for male subfertility

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Summary of findings 5. IVF compared to IUI in natural cycles for male subfertility

IVF compared to IUI in natural cycles for male subfertility
Patient or population: couples with male subfertility Settings: single centre (the Netherlands) Intervention: IVF Comparison: IUI in natural cycles
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of couples (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	IUI in natural cycles	IVF
Live birth rate per couple (all cycles) Follow‐up: 6 months	407 per 1000	346 per 1000 (147 to 618)	OR 0.77 (0.25 to 2.35)	53 (1 study)	⊕⊕⊝⊝ low¹	‐
OHSS	Not reported in any included studies				‐	‐
The basis for the assumed risk* was the median control group risk across studies. 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; IUI: intra‐uterine insemination; IVF: in vitro fertilisation; OHSS: ovarian hyperstimulation syndrome; 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 There was very serious imprecision, with small sample sizes.

Summary of findings 5. IVF compared to IUI in natural cycles for male subfertility

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Summary of findings 6. IVF compared to IUI in stimulated cycles for male subfertility

IVF compared to IUI in stimulated cycles for male subfertility
Patient or population: couples with male subfertility Settings: single and multicentre (the Netherlands) Intervention: IVF Comparison: IUI in stimulated cycles
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of couples (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	IUI in stimulated cycles	IVF
Live birth rate per couple (all cycles) Follow‐up: 6‐12 months	452 per 1000	460 per 1000 (262 to 669)	OR 1.03 (0.43 to 2.45)	86 (2 studies)	⊕⊝⊝⊝ very low^1,2	‐
OHSS per couple Follow‐up: 6 months	See comment	See comment	Not estimable	36 (1 study)	⊕⊝⊝⊝ very low^1,2	No OHSS occurred
Pregnancy rate per couple (all cycles) Follow‐up: 6 months	611 per 1000	666 per 1000 (341 to 886)	OR 1.27 (0.33 to 4.97)	36 (1 study)	⊕⊝⊝⊝ very low^1,2	‐
The basis for the assumed risk* was the median control group risk across studies. 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; IUI: intra‐uterine insemination; IVF: in vitro fertilisation; OHSS: ovarian hyperstimulation syndrome; 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 Risk of bias was serious: Bensdorp 2015, other bias: high risk (no stratification by diagnosis category of subfertility). ² There was very serious imprecision, with small sample sizes.

Summary of findings 6. IVF compared to IUI in stimulated cycles for male subfertility

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Comparison 1. Intra‐uterine insemination (IUI) versus timed intercourse (TI) both in natural cycles (NC)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Pregnancy rate per couple (all cycles) Show forest plot	2	62	Odds Ratio (M‐H, Fixed, 95% CI)	4.57 [0.21, 101.61]

Comparison 1. Intra‐uterine insemination (IUI) versus timed intercourse (TI) both in natural cycles (NC)

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Comparison 2. Intra‐uterine insemination (IUI) versus timed intercourse (TI) both in cycles with ovarian hyperstimulation (OH)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Live birth rate per couple (all cycles) Show forest plot	1	81	Odds Ratio (M‐H, Fixed, 95% CI)	0.89 [0.30, 2.59]

2 OHSS per couple Show forest plot	1	59	Odds Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

3 Pregnancy rate per couple (all cycles) Show forest plot	3	202	Odds Ratio (M‐H, Fixed, 95% CI)	1.51 [0.74, 3.07]

4 Multiple pregnancy rate per couple Show forest plot	1	81	Odds Ratio (M‐H, Fixed, 95% CI)	3.15 [0.12, 79.69]

5 Miscarriage rate per couple Show forest plot	1	81	Odds Ratio (M‐H, Fixed, 95% CI)	1.03 [0.19, 5.42]

Comparison 2. Intra‐uterine insemination (IUI) versus timed intercourse (TI) both in cycles with ovarian hyperstimulation (OH)

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Comparison 4. Intra‐uterine insemination (IUI) in cycles with ovarian hyperstimulation (OH) versus timed intercourse (TI) in natural cycles (NC)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Live birth rate per couple (all cycles) Show forest plot	1	44	Odds Ratio (M‐H, Fixed, 95% CI)	3.14 [0.12, 81.35]

2 Pregnancy rate per couple (all cycles) Show forest plot	1	44	Odds Ratio (M‐H, Fixed, 95% CI)	3.14 [0.12, 81.35]

Comparison 4. Intra‐uterine insemination (IUI) in cycles with ovarian hyperstimulation (OH) versus timed intercourse (TI) in natural cycles (NC)

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Comparison 5. Intra‐uterine insemination (IUI) in cycles with ovarian hyperstimulation (OH) versus IUI in natural cycles (NC)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Live birth rate per couple (all cycles) Show forest plot	3	346	Odds Ratio (M‐H, Fixed, 95% CI)	1.34 [0.77, 2.33]

1.1 Gonadotrophins	2	305	Odds Ratio (M‐H, Fixed, 95% CI)	1.31 [0.75, 2.29]
1.2 Gonadotrophins + clomiphene citrate (CC)	1	41	Odds Ratio (M‐H, Fixed, 95% CI)	2.72 [0.10, 70.79]
2 Pregnancy rate per couple (all cycles) Show forest plot	4	399	Odds Ratio (M‐H, Fixed, 95% CI)	1.68 [1.00, 2.82]

2.1 Gonadotrophins	2	328	Odds Ratio (M‐H, Fixed, 95% CI)	1.60 [0.94, 2.73]
2.2 CC	1	30	Odds Ratio (M‐H, Fixed, 95% CI)	4.83 [0.18, 128.79]
2.3 Gonadotrophins + CC	1	41	Odds Ratio (M‐H, Fixed, 95% CI)	2.72 [0.10, 70.79]
3 Miscarriage rate per couple Show forest plot	2	115	Odds Ratio (M‐H, Fixed, 95% CI)	1.06 [0.20, 5.63]

Comparison 5. Intra‐uterine insemination (IUI) in cycles with ovarian hyperstimulation (OH) versus IUI in natural cycles (NC)

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Comparison 8. In vitro fertilisation (IVF) versus intra‐uterine insemination (IUI) in natural cycles (NC)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Live birth rate per couple (all cycles) Show forest plot	1	53	Odds Ratio (M‐H, Fixed, 95% CI)	0.77 [0.25, 2.35]

Comparison 8. In vitro fertilisation (IVF) versus intra‐uterine insemination (IUI) in natural cycles (NC)

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Comparison 9. In vitro fertilisation (IVF) versus intra‐uterine insemination (IUI) in cycles with ovarian hyperstimulation (OH)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Live birth rate per couple (all cycles) Show forest plot	2	86	Odds Ratio (M‐H, Fixed, 95% CI)	1.03 [0.43, 2.45]

2 OHSS per couple Show forest plot	1	36	Odds Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

3 Pregnancy rate per couple (all cycles) Show forest plot	1	36	Odds Ratio (M‐H, Fixed, 95% CI)	1.27 [0.33, 4.97]

Comparison 9. In vitro fertilisation (IVF) versus intra‐uterine insemination (IUI) in cycles with ovarian hyperstimulation (OH)

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