Purpose

Nifedipine is a calcium channel blocker with smooth muscle relaxing properties. This study set out to investigate the efficacy of nifedipine administered orally before embryo transfer (ET) on the improvement of the intracytoplasmic sperm injection (ICSI) outcome. This randomized, double-blind, comparator-controlled, was carried out between 2019 and 2020 in the infertility center of Babol, Iran. 200 women candidates for ICSI and recipients of frozen-thawed ET aged 18–40 years were randomly assigned in the ratio 1:1 to an intervention group that received nifedipine 20 mg tablets orally 30 min before ET (n = 100) or to a group of placebo (n = 100). A randomization center in Babol University of Medical Science used computer-generated numbers to allocate treatments. The allocation treatment was blind to the participants, the sonographer of endometer monitoring, the staff of the ICSI laboratory, and the outcome assessor. The primary analysis was based on the intention-to-treat principle done on 200 participants, (n = 100), comparing chemical pregnancy rates in the two comparing groups at 14 days’ follow-up after ET. Implantation rate and clinical pregnancy were considered secondary outcomes.

Result

200 participants were analyzed. There is no significant difference in the number of oocytes and the quality of embryos in the nifedipine and placebo groups. Despite a numerical increase in the rate of chemical pregnancy, there were no statistical differences in the study group versus the comparison group (24% vs 14%, P = 0.1, rate ratio 0.88, 95% CI 0.77 to 1.01), respectively. Also, no significant increase in clinical pregnancy was found compared with the placebo (17% vs 8%, P = 0.26, rate ratio 0.90, 0.81 to 1.00).

Conclusion

Nifedipine administered orally 30 min before embryo transfer did not improve the chemical pregnancy rate, and clinical pregnancy rate in infertile women undergoing ICSI. This trial has been registered on the Iranian Clinical Trials Registration Site (IRCT) with the number IRCT20180417039338N3.

中文翻译：

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胚胎移植前硝苯地平给药对 ICSI 周期生殖结果的影响，一项双盲对照试验研究

目的

硝苯地平是一种钙通道阻滞剂，具有平滑肌松弛特性。本研究旨在调查胚胎移植（ET）前口服硝苯地平对改善胞浆内单精子注射（ICSI）结果的功效。这项随机、双盲、对照对照试验于 2019 年至 2020 年间在伊朗巴博尔不孕不育中心进行。 200 名年龄 18-40 岁的 ICSI 候选者和冻融 ET 接受者按 1:1 的比例随机分配到在 ET 前 30 分钟口服硝苯地平 20 mg 片剂的干预组 ( n  = 100) 或另一组安慰剂 ( n  = 100)。巴博尔医科大学的随机中心使用计算机生成的数字来分配治疗。分配治疗对参与者、内窥镜监测超声医师、ICSI 实验室工作人员和结果评估员是不知情的。主要分析基于对 200 名参与者（n  = 100）进行的意向治疗原则，比较了 ET 后 14 天随访时两个比较组的生化妊娠率。着床率和临床妊娠被认为是次要结局。

结果

对 200 名参与者进行了分析。硝苯地平组和安慰剂组的卵母细胞数量和胚胎质量没有显着差异。尽管生化妊娠发生率在数值上有所增加，但研究组与对照组之间没有统计学差异（分别为24% vs 14%，P  = 0.1，发生率比0.88，95% CI 0.77至1.01）。此外，与安慰剂相比，临床妊娠率没有显着增加（17% vs 8%，P  = 0.26，率比 0.90、0.81 至 1.00）。

结论

胚胎移植前 30 分钟口服硝苯地平并不能提高接受 ICSI 的不孕妇女的生化妊娠率和临床妊娠率。该试验已在伊朗临床试验注册网站（IRCT）注册，注册号为 IRCT20180417039338N3。