Semen preparation techniques for intrauterine insemination

Carolien M. Boomsma; Ben J Cohlen; Cindy Farquhar

doi:10.1002/14651858.CD004507.pub4

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Figure 1

PRISMA study flow diagram (updated search 2019)

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Figure 2

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

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Figure 3

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

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Figure 4

Forest plot of comparison: 1 Swim‐up versus gradient technique; fresh semen, outcome: 1.1 Clinical pregnancy rate per couple.

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Figure 5

Forest plot of comparison: 1 Swim‐up versus gradient technique; fresh semen, outcome: 1.4 Miscarriage rate per couple.

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Figure 6

Forest plot of comparison: 2 Swim‐up versus wash and centrifugation; fresh semen, outcome: 2.1 Clinical pregnancy rate per couple.

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Figure 7

Forest plot of comparison: 3 Gradient technique versus wash and centrifugation; fresh semen, outcome: 3.1 Clinical pregnancy rate per couple.

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Analysis 1.1

Comparison 1 Swim‐up versus gradient technique, fresh semen, Outcome 1 Clinical pregnancy rate per couple.

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Analysis 1.2

Comparison 1 Swim‐up versus gradient technique, fresh semen, Outcome 2 Ongoing pregnancy rate.

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Analysis 1.3

Comparison 1 Swim‐up versus gradient technique, fresh semen, Outcome 3 Multiple pregnancy rate per couple.

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Analysis 1.4

Comparison 1 Swim‐up versus gradient technique, fresh semen, Outcome 4 Miscarriage rate per couple.

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Analysis 2.1

Comparison 2 Swim‐up versus wash and centrifugation, fresh semen, Outcome 1 Clinical pregnancy rate per couple.

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Analysis 2.2

Comparison 2 Swim‐up versus wash and centrifugation, fresh semen, Outcome 2 Multiple pregnancy rate per couple.

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Analysis 2.3

Comparison 2 Swim‐up versus wash and centrifugation, fresh semen, Outcome 3 Miscarriage rate per couple.

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Analysis 3.1

Comparison 3 Gradient technique versus wash and centrifugation, fresh semen, Outcome 1 Clinical pregnancy rate per couple.

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Analysis 3.2

Comparison 3 Gradient technique versus wash and centrifugation, fresh semen, Outcome 2 Multiple pregnancy rate per couple.

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Analysis 3.3

Comparison 3 Gradient technique versus wash and centrifugation, fresh semen, Outcome 3 Miscarriage rate per couple.

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Summary of findings for the main comparison. Swim‐up technique compared to gradient technique for undergoing intrauterine insemination

Swim‐up technique compared to gradient technique for undergoing intrauterine insemination
Patient or population: patients undergoing intrauterine insemination (fresh semen) Intervention: swim‐up technique Comparison: gradient technique
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No. of participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Gradient technique	Swim‐up technique
Live birth rate per couple	See comment	See comment				No studies reported on this outcome.
Clinical pregnancy rate per couple	244 per 1000	212 per 1000 (142 to 304)	OR 0.83 (0.51 to 1.35)	370 (4 studies)	⊕⊝⊝⊝ Very Low^{a,b,c, g}
Ongoing pregnancy rate per couple	234 per 1000	107 per 1000 (55 to 201)	OR 0.39 (0.19 to 0.82)	223 (1 study)	⊕⊝⊝⊝ Very Low^d,e
Multiple pregnancy rate per couple	See comment	See comment	Not estimable	25 (1 study)	⊕⊝⊝⊝ Very Low^d,e	There were no events recorded in either group
Miscarriage rate per couple	38 per 1000	33 per 1000 (11 to 94)	OR 0.85 (0.28 to 2.59)	330 (3 studies)	⊕⊝⊝⊝ Very Low^a,f,c
The basis for the assumed risk* (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% CI) 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.
^a Risk of bias, downgrade 1 level: unclear risk of bias, no adequate explanation for randomisation or allocation concealment or attrition. High risk of performance bias. ^b Inconsistency, downgrade 1 level: I² statistic was 71% indicating substantial statistical heterogeneity and a plausible explanation was not found. ^c Serious imprecision, downgrade 1 level: there were signs of imprecision concerning wide confidence intervals due to small sample size and small number of events. ^d Very serious imprecision, downgrade 2 levels: wide confidence interval around effect estimate due to small sample size and small number of/no events. ^e Evidence based on a single RCT of limited sample size, downgrade 1 level. ^f Inconsistency, downgrade 1 level: little overlap confidence intervals and moderate statistical heterogeneity. ^g Other bias, downgrade 1 level: definition of pregnancy not described.

Summary of findings for the main comparison. Swim‐up technique compared to gradient technique for undergoing intrauterine insemination

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Summary of findings 2. Swim‐up technique compared to wash and centrifugation for undergoing intrauterine insemination

Swim‐up technique compared to wash and centrifugation for undergoing intrauterine insemination
Patient or population: patients undergoing intrauterine insemination (fresh semen) Intervention: swim‐up technique Comparison: wash and centrifugation
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No. of participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Wash and centrifugation	Swim‐up technique
Live birth rate per couple	See comment	See comment				No studies reported on this outcome.
Clinical pregnancy rate per couple	381 per 1000	201 per 1000 (85 to 410)	OR 0.41 (0.15 to 1.13)	78 (2 studies)	⊕⊝⊝⊝ very low^a,b,c
Ongoing pregnancy rate per couple	See comment	See comment				No studies reported on this outcome.
Multiple pregnancy rate per couple	63 per 1000	32 per 1000 (1 to 470)	OR 0.49 (0.02 to 13.28)	26 (1 study)	⊕⊝⊝⊝ very low^d,e
Miscarriage rate per couple	See comment	See comment	Not estimable	20 (1 study)	⊕⊝⊝⊝ very low^d,e	There were no events in either group
The basis for the assumed risk* (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% CI) 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.
^a Risk of bias, downgrade 1 level: 1 of the 2 trials did not conceal allocation and there was no blinding. High risk of performance bias. ^b Inconcistency, downgrade 1 level: Little overlap in confidence intervals. I² statistic was 55% indicating substantial statistical heterogeneity and a plausible explanation was not found. ^c Serious imprecision, downgrade 1 level: there were signs of imprecision concerning wide confidence intervals due to small sample size and small number of events. ^d Very serious imprecision, downgrade 2 levels: wide confidence interval around effect estimate due to small sample size and small number of/no events. ^e Downgrade 1 level: Evidence based on a single RCT of limited sample size.

Summary of findings 2. Swim‐up technique compared to wash and centrifugation for undergoing intrauterine insemination

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Summary of findings 3. Gradient technique compared to wash and centrifugation for undergoing intrauterine insemination

Gradient technique compared to Wash and centrifugation for undergoing intrauterine insemination
Patient or population: patients with undergoing intrauterine insemination (fresh semen) Intervention: gradient technique Comparison: wash and centrifugation
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No. of participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Wash and centrifugation	Gradient technique
Live birth rate per couple	See comment	See comment				No studies reported on this outcome.
Clinical pregnancy rate per couple	133 per 1000	215 per 1000 (82 to 457)	OR 1.78 (0.58 to 5.46)	94 (2 studies)	⊕⊝⊝⊝ very low^{a, b, c, f}
Ongoing pregnancy rate per couple	See comment	See comment				No studies reported on this outcome.
Multiple pregnancy rate per couple	63 per 1000	22 per 1000 (1 to 371)	OR 0.33 (0.01 to 8.83)	31 (1 study)	⊕⊝⊝⊝ very low^d,e
Miscarriage rate per couple	no events (0/16)	2/15 see comment	OR 6.11 (0.27 to 138.45)	31 (1 study)	⊕⊝⊝⊝ very low^d,e	Corresponding risk not estimable since there were no events in "wash and centrifugation" (0/16).
The basis for the assumed risk* (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% CI) 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.
^a Risk of bias, downgrade 1 level: 1 of the 2 trials did not provide adequate details on randomisation or allocation concealment and did not use blinding, abstract. High risk of performance bias. ^b Inconsistency, downgrade 1 level: I² statistic was 52% indicating substantial statistical heterogeneity. ^c Serious imprecision, downgrade 1 level: there were signs of imprecision concerning wide confidence intervals due to small sample size and small number of events. ^d Very serious imprecision, downgrade 2 levels: wide confidence interval around effect estimate due to small sample size and small number of/no events. ^e Downgrade 1 level: evidence based on a single RCT of limited sample size. ^f Other bias, downgrade 1 level: definition of pregnancy not described.

Summary of findings 3. Gradient technique compared to wash and centrifugation for undergoing intrauterine insemination

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Table 1. Characteristics of cross‐over RCTs excluded from meta‐analysis

Study ID	Allocation Score	Methods	Participants	Interventions	Outcomes
Carrell 1998	B	Stated random, but no details. Design: cross‐over, multi‐centre. Concealment of allocation, blinding, number of dropouts or cancelled cycles, intention‐to‐treat analysis, power calculation: all not stated.	363 women: 558 cycles in the 3 methods of interest. Age of women, duration subfertility: not stated. Cause: unexplained/(fe)male related disorders. Exclusion criteria: oligoasthenozoospermic semen samples after preparation. Inclusion criteria: not stated.	3 preparation techniques (out of 5 described). 1) Sperm wash: 8 to 10 ml. medium (Ham's F‐10), 10 min. 400 × g centrifugation. Supernatant decanted, pellet resuspended. 2) Swim‐up: 2× washed, resuspended. Medium layered on top. Incubation 1h. Top removed. 3) Gradient: 1x wash + resuspension. Percoll, (35%/ 90%).15 min 400 × g centrifugation. 90% layer washed. Single IUI. 2.5 ± 0.3 inseminations per women. 124 women: 50 to 200 mg. CC day 5 to 9 or no COH. 239 women: gonadotropin/hCG.	Clinical pregnancy rate (CPR)/cycle, Miscarriage rate (MR)/pregnancy, Live birth rate (LBR)/ cycle

Table 1. Characteristics of cross‐over RCTs excluded from meta‐analysis

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Table 2. Results from cross‐over RCTs excluded from meta‐analysis

Study ID	Sample Size	Gradient technique	Swim‐up	Wash and centrifuge	Conclusion	Statistical analysis
Carrell 1998	558 cycles	CPR/cycle: 16% (33/204), LBR/ cycle: 13% (26/204), MR/pregnancy: 21% (7/33)	CPR/cycle: 15% (29/197), LBR/cycle: 13% (26/197), MR/pregnancy: 10 % (3/29)	CPR/cycle: 9% (14/157), LBR/cycle: 7% (11/157), MR/pregnancy: 21% (3/14)	CPR/cycle wash‐method significantly lower than Swim‐up/Percoll (P < 0.05), LBR/cycle wash‐method significantly lower than Swim‐up/Percoll (P < 0.05). No other significant differences.	CPR/cycle and MR/pregnancy: ×2 analysis and Fisher's exact test. Statistical significance P < 0.05.

Table 2. Results from cross‐over RCTs excluded from meta‐analysis

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Comparison 1. Swim‐up versus gradient technique, fresh semen

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Clinical pregnancy rate per couple Show forest plot	4	370	Odds Ratio (M‐H, Fixed, 95% CI)	0.83 [0.51, 1.35]

2 Ongoing pregnancy rate Show forest plot	1	223	Odds Ratio (M‐H, Fixed, 95% CI)	0.39 [0.19, 0.82]

3 Multiple pregnancy rate per couple Show forest plot	1	25	Odds Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

4 Miscarriage rate per couple Show forest plot	3	330	Odds Ratio (M‐H, Fixed, 95% CI)	0.85 [0.28, 2.59]

Comparison 1. Swim‐up versus gradient technique, fresh semen

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Comparison 2. Swim‐up versus wash and centrifugation, fresh semen

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Clinical pregnancy rate per couple Show forest plot	2	78	Odds Ratio (M‐H, Fixed, 95% CI)	0.41 [0.15, 1.13]

2 Multiple pregnancy rate per couple Show forest plot	1	26	Odds Ratio (M‐H, Fixed, 95% CI)	0.49 [0.02, 13.28]

3 Miscarriage rate per couple Show forest plot	1	20	Odds Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

Comparison 2. Swim‐up versus wash and centrifugation, fresh semen

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Comparison 3. Gradient technique versus wash and centrifugation, fresh semen

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Clinical pregnancy rate per couple Show forest plot	2	94	Odds Ratio (M‐H, Fixed, 95% CI)	1.78 [0.58, 5.46]

2 Multiple pregnancy rate per couple Show forest plot	1	31	Odds Ratio (M‐H, Fixed, 95% CI)	0.33 [0.01, 8.83]

3 Miscarriage rate per couple Show forest plot	1	31	Odds Ratio (M‐H, Fixed, 95% CI)	6.11 [0.27, 138.45]

Comparison 3. Gradient technique versus wash and centrifugation, fresh semen

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