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. 2021 Sep 1;9(9):CD012375.
doi: 10.1002/14651858.CD012375.pub2.

Oxytocin antagonists for assisted reproduction

Laurentiu Craciunas  1 , Nikolaos Tsampras  2 , Martina Kollmann  3 , Nick Raine-Fenning  4 , Meenakshi Choudhary  5
Affiliations

Oxytocin antagonists for assisted reproduction

Laurentiu Craciunas et al. Cochrane Database Syst Rev. .

Abstract

Background: Embryo transfer (ET) is a crucial step of in vitro fertilisation (IVF) treatment, and involves placing the embryo(s) in the woman's uterus. There is a negative association between endometrial wave-like activity (contractile activities) at the time of ET and clinical pregnancy, but no specific treatment is currently used in clinical practice to counteract their effects. Oxytocin is a hormone produced by the hypothalamus and released by the posterior pituitary. Its main role involves generating uterine contractions during and after childbirth. Atosiban is the best known oxytocin antagonist (and is also a vasopressin antagonist), and it is commonly used to delay premature labour by halting uterine contractions. Other oxytocin antagonists include barusiban, nolasiban, epelsiban, and retosiban. Administration of oxytocin antagonists around the time of ET has been proposed as a means to reduce uterine contractions that may interfere with embryo implantation. The intervention involves administering the medication before, during, or after the ET (or a combination).

Objectives: To evaluate the effectiveness and safety of oxytocin antagonists around the time of ET in women undergoing assisted reproduction.

Search methods: We searched the Cochrane Gynaecology and Fertility (CGF) Group trials register, CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL, and two trials registers in March 2021; and checked references and contacted study authors and experts in the field to identify additional studies.

Selection criteria: We included randomised controlled trials (RCTs) of the use of oxytocin antagonists for women undergoing ET, compared with the non-use of this intervention, the use of placebo, or the use of another similar drug.

Data collection and analysis: We used standard methodological procedures recommended by Cochrane. Primary review outcomes were live birth and miscarriage; secondary outcomes were clinical pregnancy and other adverse events.

Main results: We included nine studies (including one comprising three separate trials, 3733 women analysed in total) investigating the role of three different oxytocin antagonists administered intravenously (atosiban), subcutaneously (barusiban), or orally (nolasiban). We found very low- to high-certainty evidence: the main limitations were serious risk of bias due to poor reporting of study methods, and serious or very serious imprecision. Intravenous atosiban versus normal saline or no intervention We are uncertain of the effect of intravenous atosiban on live birth rate (risk ratio (RR) 1.05, 95% confidence interval (CI) 0.88 to 1.24; 1 RCT, N = 800; low-certainty evidence). In a clinic with a live birth rate of 38% per cycle, the use of intravenous atosiban would be associated with a live birth rate ranging from 33.4% to 47.1%. We are uncertain whether intravenous atosiban influences miscarriage rate (RR 1.08, 95% CI 0.75 to 1.56; 5 RCTs, N = 1424; I² = 0%; very low-certainty evidence). In a clinic with a miscarriage rate of 7.2% per cycle, the use of intravenous atosiban would be associated with a miscarriage rate ranging from 5.4% to 11.2%. Intravenous atosiban may increase clinical pregnancy rate (RR 1.50, 95% CI 1.18 to 1.89; 7 RCTs, N = 1646; I² = 69%; low-certainty evidence), and we are uncertain whether multiple or ectopic pregnancy and other complication rates were influenced by the use of intravenous atosiban (very low-certainty evidence). Subcutaneous barusiban versus placebo One study investigated barusiban, but did not report on live birth or miscarriage. We are uncertain whether subcutaneous barusiban influences clinical pregnancy rate (RR 0.96, 95% CI 0.69 to 1.35; 1 RCT, N = 255; very low-certainty evidence). Trialists reported more mild to moderate injection site reactions with barusiban than with placebo, but there was no difference in severe reactions. They reported no serious drug reactions; and comparable neonatal outcome between groups. Oral nolasiban versus placebo Nolasiban does not increase live birth rate (RR 1.13, 95% CI 0.99 to 1.28; 3 RCTs, N = 1832; I² = 0%; high-certainty evidence). In a clinic with a live birth rate of 33% per cycle, the use of oral nolasiban would be associated with a live birth rate ranging from 32.7% to 42.2%. We are uncertain of the effect of oral nolasiban on miscarriage rate (RR 1.45, 95% CI 0.73 to 2.88; 3 RCTs, N = 1832; I² = 0%; low-certainty evidence). In a clinic with a miscarriage rate of 1.5% per cycle, the use of oral nolasiban would be associated with a miscarriage rate ranging from 1.1% to 4.3%. Oral nolasiban improves clinical pregnancy rate (RR 1.15, 95% CI 1.02 to 1.30; 3 RCTs, N = 1832; I² = 0%; high-certainty evidence), and probably does not increase multiple or ectopic pregnancy, or other complication rates (moderate-certainty evidence).

Authors' conclusions: We are uncertain whether intravenous atosiban improves pregnancy outcomes for women undergoing assisted reproductive technology. This conclusion is based on currently available data from seven RCTs, which provided very low- to low-certainty evidence across studies. We could draw no clear conclusions about subcutaneous barusiban, based on limited data from one RCT. Further large well-designed RCTs reporting on live births and adverse clinical outcomes are still required to clarify the exact role of atosiban and barusiban before ET. Oral nolasiban appears to improve clinical pregnancy rate but not live birth rate, with an uncertain effect on miscarriage and adverse events. This conclusion is based on a phased study comprising three trials that provided low- to high-certainty evidence. Further large, well-designed RCTs, reporting on live births and adverse clinical outcomes, should focus on identifying the subgroups of women who are likely to benefit from this intervention.

Trial registration: ClinicalTrials.gov NCT01673399 NCT02893722 NCT03904745.

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Conflict of interest statement

LC has no conflicts of interest to disclose. NT has no conflicts of interest to disclose. MK has no conflicts of interest to disclose. NRF has received travel costs and honoraria from GE Healthcare, Merck Serono, and Ferring for attending advisory board meetings. Ferring are manufacturers of the oxytocin antagonists atosiban and barusiban. NRF holds shares in two private fertility clinics. MC has received assistance with travel costs from Ferring, Cook Medical, and B. Braun. Ferring are manufacturers of the oxytocin antagonists atosiban and barusiban.

Figures

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1
Study flow diagram
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Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies
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Risk of bias summary: review authors' judgements about each risk of bias item for each included study
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Forest plot of comparison: 1 Oxytocin antagonists vs control, outcome: 1.1 Live birth.
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Forest plot of comparison: 1 Oxytocin antagonists vs control, outcome: 1.2 Miscarriage.
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Forest plot of comparison: 1 Oxytocin antagonists vs control, outcome: 1.3 Miscarriage per clinical pregnancy.
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Forest plot of comparison: 1 Oxytocin antagonists vs control, outcome: 1.4 Clinical pregnancy.
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Forest plot of comparison: 1 Oxytocin antagonists vs control, outcome: 1.5 Complications.
1.1
1.1. Analysis
Comparison 1: Oxytocin antagonists vs control, Outcome 1: Live birth
1.2
1.2. Analysis
Comparison 1: Oxytocin antagonists vs control, Outcome 2: Miscarriage
1.3
1.3. Analysis
Comparison 1: Oxytocin antagonists vs control, Outcome 3: Miscarriage per clinical pregnancy
1.4
1.4. Analysis
Comparison 1: Oxytocin antagonists vs control, Outcome 4: Clinical pregnancy
1.5
1.5. Analysis
Comparison 1: Oxytocin antagonists vs control, Outcome 5: Complications
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References

References to studies included in this review

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ChiCTR1900020795 {published data only}
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