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. 2023 Aug 15;8(8):CD001301.
doi: 10.1002/14651858.CD001301.pub2.

Intracytoplasmic sperm injection versus conventional in vitro fertilisation in couples with males presenting with normal total sperm count and motility

Elizabeth Cutting  1 , Fabrizzio Horta  1   2   3 , Vinh Dang  4 , Minouche Me van Rumste  5 , Ben Willem J Mol  1   6
Affiliations

Intracytoplasmic sperm injection versus conventional in vitro fertilisation in couples with males presenting with normal total sperm count and motility

Elizabeth Cutting et al. Cochrane Database Syst Rev. .

Abstract

Background: Starting over 40 years ago, in vitro fertilisation (IVF) has become the cornerstone for fertility treatment. Since then, in 1992, Palermo and colleagues successfully applied the technique intracytoplasmic sperm injection (ICSI) to benefit couples where conventional in vitro fertilisation (c-IVF) and sub-zonal insemination (SUZI) proved unsuccessful. After this case report, ICSI has become the treatment of choice for couples with severe male factor subfertility. Over time, ICSI has been used in the treatment of couples with mild male and even unexplained infertility. This review is an update of the review, first published in 1999, comparing ICSI with c-IVF for couples with males presenting with normal total sperm count and motility.

Objectives: To evaluate the effectiveness and safety of ICSI relative to c-IVF in couples with males presenting with normal total sperm count and motility.

Search methods: We searched the following databases and trial registers: Cochrane Central Register of Controlled Trials (CENTRAL), Embase (excerpta Medica Database), MEDLINE (Medical Literature Analysis and Retrieval System Online) and PsycINFO (Psychological literature database) for articles between January 2010 and 22 February 2023.

Selection criteria: We included randomised controlled trials (RCTs) that compared ICSI with c-IVF in couples with males presenting with normal total sperm count and motility.

Data collection and analysis: We used standard methodical procedures recommended by Cochrane. The primary review outcomes were live birth and adverse events. Secondary outcomes included clinical pregnancy, viable intrauterine pregnancy and miscarriage.

Main results: The original review published in 2003 included one RCT. In this 2023 update, we identified an additional two RCTs totalling a cohort of 1539 couples, comparing ICSI with c-IVF techniques. Two studies reported on live birth. Using the GRADE method, we assessed the certainty of evidence and reported evidence as low-certainty for live birth. We are uncertain of the effect of ICSI versus c-IVF for live birth rates (risk ratio (RR) 1.11, 95% confidence interval (CI 0.94 to 1.30, I2 = 0%, 2 studies, n = 1124, low-certainty evidence). The evidence suggests that if the chance of live birth following c-IVF is assumed to be 32%, the chance of live birth with ICSI would be between 30% and 41%. For adverse events; multiple pregnancy, ectopic pregnancy, pre-eclampsia and prematurity, there was probably little or no difference between the two techniques. No study reported the primary outcome stillbirth. For secondary outcomes, we are uncertain of the effect of ICSI versus c-IVF for clinical pregnancy rates (RR 1.00, 95% CI 0.88 to 1.13, I2 = 45%, 3 studies, n = 1539, low-certainty evidence). Comparison of viable intrauterine pregnancy rates showed probably little or no difference between ICSI and c-IVF (RR 1.00, 95% CI 0.86 to 1.16, I2=75%, 2 studies, n = 1479 couples, moderate-certainty evidence). The high heterogeneity may have been caused by one older study conducted when protocols were less rigorous. The evidence suggests that if the chance of viable intrauterine pregnancy following c-IVF is assumed to be 33%, the chance of viable intrauterine pregnancy with ICSI would be between 28% and 38%. Miscarriage rates also showed probably little or no difference between the two techniques.

Authors' conclusions: The current available studies that compare ICSI and c-IVF in couples with males presenting with normal total sperm count and motility, show neither method was superior to the other, in achieving live birth, adverse events (multiple pregnancy, ectopic pregnancy, pre-eclampsia and prematurity), also alongside secondary outcomes, clinical pregnancy, viable intrauterine pregnancy or miscarriage.

PubMed Disclaimer

Conflict of interest statement

It is important to declare that BWM and VD took no part in selection of studies, assessment for risk of bias through GRADE or extracting the data.

EC, VD, FH and MvR have no interests to declare.

BWM is supported by a NHMRC Investigator grant (GNT1176437). BWM reports consultancy for ObsEva. BMW has received research funding from Ferring and Merck.

Figures

1
1
Study flow diagram.
2
2
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
3
3
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
4
4
Forest Plot for live birth rate. Each marker represents the estimate summary risk ratio for each comparison; each horizontal line represents confidence interval for each comparison; black vertical line represents line of no effect (risk ratio =1). Risk ratio greater than 1 favours the ICSI; risk ratio less than 1 favours c‐IVF
5
5
Forest Plot for multiple pregnancy rate. Each marker represents the estimate summary risk ratio for each comparison; each horizontal line represents confidence interval for each comparison; black vertical line represents line of no effect (risk ratio =1). Risk ratio greater than 1 favours the ICSI; risk ratio less than 1 favours c‐IVF
6
6
Forest Plot for clinical pregnancy rates. Each marker represents the estimate summary risk ratio for each comparison; each horizontal line represents confidence interval for each comparison; black vertical line represents line of no effect (risk ratio =1). Risk ratio greater than 1 favours the ICSI; risk ratio less than 1 favours c‐IVF
7
7
Forest Plot for viable intrauterine pregnancy rate. Each marker represents the estimate summary risk ratio for each comparison; each horizontal line represents confidence interval for each comparison; black vertical line represents line of no effect (risk ratio =1). Risk ratio greater than 1 favours the ICSI; risk ratio less than 1 favours c‐IVF
1.1
1.1. Analysis
Comparison 1: ICSI vs. c‐IVF, Outcome 1: Live birth
1.2
1.2. Analysis
Comparison 1: ICSI vs. c‐IVF, Outcome 2: Multiple pregnancy
1.3
1.3. Analysis
Comparison 1: ICSI vs. c‐IVF, Outcome 3: Ectopic pregnancy
1.4
1.4. Analysis
Comparison 1: ICSI vs. c‐IVF, Outcome 4: Pre‐eclampsia
1.5
1.5. Analysis
Comparison 1: ICSI vs. c‐IVF, Outcome 5: Prematurity
1.6
1.6. Analysis
Comparison 1: ICSI vs. c‐IVF, Outcome 6: Clinical pregnancy
1.7
1.7. Analysis
Comparison 1: ICSI vs. c‐IVF, Outcome 7: Viable intrauterine pregnancy
1.8
1.8. Analysis
Comparison 1: ICSI vs. c‐IVF, Outcome 8: Miscarriage
1.9
1.9. Analysis
Comparison 1: ICSI vs. c‐IVF, Outcome 9: Fertilisation per oocyte inseminated
1.10
1.10. Analysis
Comparison 1: ICSI vs. c‐IVF, Outcome 10: Fertilisation per oocyte retrieved
1.11
1.11. Analysis
Comparison 1: ICSI vs. c‐IVF, Outcome 11: Fertilisation failure
1.12
1.12. Analysis
Comparison 1: ICSI vs. c‐IVF, Outcome 12: Implantation rate
See this image and copyright information in PMC

Update of

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References to ongoing studies

Berntsen 2021 {published data only}
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