Intrauterine administration of human chorionic gonadotropin (hCG) for subfertile women undergoing assisted reproduction

Laurentiu Craciunas; Nikolaos Tsampras; Arri Coomarasamy; Nick Raine‐Fenning

doi:10.1002/14651858.CD011537.pub2

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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 Intrauterine human chorionic gonadotropin (hCG) versus no hCG, outcome: 1.1 Live birth.

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Figure 5

Forest plot of comparison: 1 Intrauterine human chorionic gonadotropin (hCG) versus no hCG, outcome: 1.2 Miscarriage.

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Figure 6

Forest plot of comparison: 1 Intrauterine human chorionic gonadotropin (hCG) versus no hCG, outcome: 1.4 Clinical pregnancy.

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Figure 7

Forest plot of comparison: 1 Intrauterine human chorionic gonadotropin (hCG) versus no hCG, outcome: 1.5 Complications: intrauterine death.

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Analysis 1.1

Comparison 1 Intrauterine human chorionic gonadotropin (hCG) versus no hCG, Outcome 1 Live birth.

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Analysis 1.2

Comparison 1 Intrauterine human chorionic gonadotropin (hCG) versus no hCG, Outcome 2 Miscarriage.

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Analysis 1.3

Comparison 1 Intrauterine human chorionic gonadotropin (hCG) versus no hCG, Outcome 3 Miscarriage per clinical pregnancy.

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Analysis 1.4

Comparison 1 Intrauterine human chorionic gonadotropin (hCG) versus no hCG, Outcome 4 Clinical pregnancy.

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Analysis 1.5

Comparison 1 Intrauterine human chorionic gonadotropin (hCG) versus no hCG, Outcome 5 Complications: intrauterine death.

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Summary of findings for the main comparison. Intrauterine administration of hCG for women undergoing assisted reproduction

Intrauterine administration of hCG for women undergoing assisted reproduction
Population: women undergoing assisted reproduction Settings: assisted reproduction units Intervention: intrauterine administration of hCG
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of participants (studies)	Quality of the evidence (GRADE)
	Assumed risk	Corresponding risk
	Control	Intrauterine administration of hCG
Live birth ‐ cleavage stage: hCG < 500 IU RR Follow‐up: mean 40 weeks	495 per 1000	376 per 1000 (287 to 500)	RR 0.76 (0.58 to 1.01)	280 (1 study)	⊕⊝⊝⊝ very low^1,2
Live birth ‐ cleavage stage: hCG ≥ 500 IU RR Follow‐up: mean 40 weeks	247 per 1000	388 per 1000 (326 to 462)	RR 1.57 (1.32 to 1.87)	914 (3 studies)	⊕⊕⊕⊝ moderate³
Live birth ‐ blastocyst stage: hCG ≥ 500 IU RR Follow‐up: mean 40 weeks	366 per 1000	337 per 1000 (293 to 381)	RR 0.92 (0.80 to 1.04)	1666 (2 studies)	⊕⊕⊕⊝ moderate³
Pregnancy ‐ cleavage stage: hCG < 500 IU RR Follow‐up: mean 12 weeks	579 per 1000	509 per 1000 (405 to 637)	RR 0.88 (0.70 to 1.10)	280 (1 study)	⊕⊝⊝⊝ very low^2,3,4
Pregnancy ‐ cleavage stage: hCG ≥ 500 IU RR Follow‐up: mean 12 weeks	321 per 1000	453 per 1000 (401 to 507)	RR 1.41 (1.25 to 1.58)	1414 (7 studies)	⊕⊕⊕⊝ moderate³
Pregnancy ‐ blastocyst stage: hCG ≥ 500 IU RR Follow‐up: mean 12 weeks	430 per 1000	408 per 1000 (370 to 455)	RR 0.95 (0.86 to 1.06)	1991 (3 studies)	⊕⊕⊕⊝ moderate³
Miscarriage Follow‐up: mean 40 weeks	48 per 1000	52 per 1000 (40 to 68)	RR 1.09 (0.83 to 1.43)	3395 (7 studies)	⊕⊝⊝⊝ very low^2,3,4
Other complications	Other complications reported in the included studies were ectopic pregnancy (3 studies, n = 915, 3 events overall), heterotopic pregnancy (1 study, n = 495, 1 event), intrauterine death (2 studies, n = 978, 21 events) and triplets (1 study, n = 48, 3 events). There were too few events to allow any conclusions to be drawn				⊕⊝⊝⊝ very low^2,3,4
The basis for the assumed risk* is 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; hCG: human chorionic gonadotropin; IU: international units; RR: risk 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 Downgraded two levels due to very serious risk of bias: lack of blinding of participants and personnel, no clear description of allocation concealment and premature termination of the study following interim analysis. ² Downgraded one level due to imprecision: total number of events was fewer than 300. ³ Downgraded one level due to serious risk of bias: lack of blinding of participants and personnel, no allocation concealment. ⁴ Downgraded two levels due to very serious imprecision: total number of events was fewer than 300 and 95% confidence interval around the pooled effect includes both no effect and appreciable benefit or appreciable harm.

Summary of findings for the main comparison. Intrauterine administration of hCG for women undergoing assisted reproduction

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Comparison 1. Intrauterine human chorionic gonadotropin (hCG) versus no hCG

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Live birth Show forest plot	5		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

1.1 Cleavage stage: hCG < 500 IU	1	280	Risk Ratio (M‐H, Random, 95% CI)	0.76 [0.58, 1.01]
1.2 Cleavage stage: hCG ≥ 500 IU	3	914	Risk Ratio (M‐H, Random, 95% CI)	1.57 [1.32, 1.87]
1.3 Blastocyst stage: hCG ≥ 500 IU	2	1666	Risk Ratio (M‐H, Random, 95% CI)	0.92 [0.80, 1.04]
2 Miscarriage Show forest plot	7	3395	Risk Ratio (M‐H, Random, 95% CI)	1.09 [0.83, 1.43]

3 Miscarriage per clinical pregnancy Show forest plot	7	1450	Risk Ratio (M‐H, Random, 95% CI)	1.00 [0.77, 1.30]

4 Clinical pregnancy Show forest plot	10		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

4.1 Cleavage stage: hCG < 500 IU	1	280	Risk Ratio (M‐H, Random, 95% CI)	0.88 [0.70, 1.10]
4.2 Cleavage stage: hCG ≥ 500 IU	7	1414	Risk Ratio (M‐H, Random, 95% CI)	1.41 [1.25, 1.58]
4.3 Blastocyst stage: hCG ≥ 500 IU	3	1991	Risk Ratio (M‐H, Random, 95% CI)	0.95 [0.86, 1.06]
5 Complications: intrauterine death Show forest plot	2	978	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.80 [0.33, 1.92]

Comparison 1. Intrauterine human chorionic gonadotropin (hCG) versus no hCG

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