Shanghai First Maternity and Infant Hospital, School of Medicine, Tongji University, Shanghai, 200092, China.
Reprod Biol Endocrinol. 2022 Aug 19;20(1):124. doi: 10.1186/s12958-022-00999-y.
Patients with recurrent implantation failure (RIF) may have more uterine contractions. Several observational studies suggested that atosiban administration around embryo transfer resulted in higher pregnancy rates in RIF patients. This study aimed to evaluate the effect of atosiban given before fresh embryo transfer on pregnancy outcomes of women with RIF.
A prospective, randomized, double-blind controlled clinical trial was performed in IVF center of Shanghai First Maternity and Infant Hospital. According to a computer-generated randomization list, 194 infertile women with RIF received fresh embryo transfer between July 2017 and December 2019 were randomly allocated into the atosiban (n = 97) and the placebo (n = 97) groups. Women in the treatment group received atosiban intravenously about 30 min before embryo transfer with a bolus dose of 6.75 mg over one minute. Those in the placebo group received only normal saline infusion for the same duration.
There was no significant difference in the live birth rate between the atosiban and placebo groups (42.3% vs 35.1%, P = 0.302, RR = 1.206 (0.844-1.723)). No significant differences were found between the two groups in the positive pregnancy test, clinical pregnancy, ongoing pregnancy, miscarriage, multiple pregnancy, ectopic pregnancy and implantation rates. Similar results were found when stratified by the number of embryos previously transferred, number of previous failed embryo transfers, frequency of endometrial peristalsis on embryo transfer day (≥ 3 waves/min) or serum estradiol (E) on the day of hCG above the median level. And, there was no correlation between the serum E level on the day of hCG and the frequency of endometrial peristalsis on embryo transfer day. The frequency of endometrial peristalsis on embryo transfer day, total FSH/HMG dosage and duration were the significant factors which independently predicted the likelihood of a live birth.
These results suggested that atosiban treatment before fresh embryo transfer might not improve the live birth rate in RIF patients.
The study had been approved by the Institutional Review Board of the hospital (2017 ethics No.43) and was registered under Clinicaltrials.gov with an identifier NCT02893722.
复发性植入失败（RIF）患者可能有更多的子宫收缩。几项观察性研究表明，阿托西班在胚胎移植前后给药可提高 RIF 患者的妊娠率。本研究旨在评估新鲜胚胎移植前给予阿托西班对 RIF 患者妊娠结局的影响。
本前瞻性、随机、双盲对照临床试验在上海第一妇婴保健院的体外受精中心进行。根据计算机生成的随机分组列表，2017 年 7 月至 2019 年 12 月期间，194 名 RIF 不孕妇女接受新鲜胚胎移植，随机分为阿托西班组（n=97）和安慰剂组（n=97）。治疗组妇女在胚胎移植前约 30 分钟静脉注射阿托西班，1 分钟内推注 6.75 毫克。对照组仅在相同时间内输注生理盐水。
阿托西班组和安慰剂组的活产率无显著差异（42.3%比 35.1%，P=0.302，RR=1.206（0.844-1.723））。两组间阳性妊娠试验、临床妊娠、持续妊娠、流产、多胎妊娠、异位妊娠和着床率无显著差异。按既往移植胚胎数、既往胚胎移植失败数、胚胎移植日子宫内膜蠕动频率（≥3 波/分钟）或 hCG 日血清雌二醇（E）中位数以上进行分层，结果相似。并且，hCG 日血清 E 水平与胚胎移植日子宫内膜蠕动频率之间无相关性。胚胎移植日子宫内膜蠕动频率、总 FSH/HMG 剂量和持续时间是独立预测活产可能性的显著因素。
这些结果表明，新鲜胚胎移植前给予阿托西班可能不会提高 RIF 患者的活产率。
该研究已获得医院机构审查委员会（2017 年伦理号 43）的批准，并在 Clinicaltrials.gov 上注册，标识符为 NCT02893722。
