Abstract：
OBJECTIVE: 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.
RESULTS: 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).
CONCLUSIONS: 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.
RESULTS: 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).
CONCLUSIONS: 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.
摘要：
目的：硝苯地平是一种具有平滑肌松弛特性的钙通道阻滞剂。本研究旨在研究胚胎移植（ET）前口服硝苯地平对改善卵胞浆内单精子注射（ICSI）结局的疗效。这个随机的，双盲,比较器控制，于2019年至2020年在巴博尔不孕不育中心进行，伊朗。将200名年龄在18-40岁之间的ICSI候选人和冻融ET接受者以1：1的比例随机分配到干预组，该干预组在ET前30分钟口服硝苯地平20mg片剂（n=100）或安慰剂组（n=100）。巴博尔医学科学大学的一个随机化中心使用计算机生成的数字来分配治疗。分配治疗对参与者来说是盲目的，终点监测的超声医师，ICSI实验室的工作人员，和结果评估员。主要分析基于对200名参与者进行的意向治疗原则，（n=100），比较两个比较组在ET后14天随访时的化学妊娠率。着床率和临床妊娠被认为是次要结局。
结果：分析了200名参与者。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著差异。尽管化学妊娠率在数值上有所增加，研究组与对照组相比没有统计学差异(24%vs14%，P=0.1，比率0.88，95%CI0.77至1.01)，分别。此外，与安慰剂相比，临床妊娠没有显着增加（17％vs8％，P=0.26,率比0.90,0.81~1.00)。
结论：胚胎移植前30分钟口服硝苯地平并不能提高化学妊娠率，接受ICSI的不孕妇女的临床妊娠率。该试验已在伊朗临床试验注册网站（IRCT）注册，编号为IRCT20180417039338N3。
结果：分析了200名参与者。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著差异。尽管化学妊娠率在数值上有所增加，研究组与对照组相比没有统计学差异(24%vs14%，P=0.1，比率0.88，95%CI0.77至1.01)，分别。此外，与安慰剂相比，临床妊娠没有显着增加（17％vs8％，P=0.26,率比0.90,0.81~1.00)。
结论：胚胎移植前30分钟口服硝苯地平并不能提高化学妊娠率，接受ICSI的不孕妇女的临床妊娠率。该试验已在伊朗临床试验注册网站（IRCT）注册，编号为IRCT20180417039338N3。
