Moini Ashraf, Zafarani Fatemeh, Jahangiri Nadia, Jahanian Sadatmahalleh S Hahideh, Sadeghi Marya, Chehrazi Mohammad, Ahmadi Firoozeh
Department of Endocrinology and Female Infertility, Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran.
Department of Obstetrics and Gynaecology, Tehran University of Medical Sciences, Tehran, Iran.
Int J Fertil Steril. 2020 Jan;13(4):289-295. doi: 10.22074/ijfs.2020.5681. Epub 2019 Nov 11.
The aim of this study was to investigate the effects of vaginal sildenafil on the outcome of patients with at least two unsuccessful fertilization/intracytoplasmic sperm injection (IVF/ICSI) attempts.
In this randomized placebo-controlled trial study, a total of 66 infertile women aged ≤38 years, with a history of normal ovarian reserve, two prior consecutive failed IVF/ICSI attempts, human chorionic gonadotropin (hCG) day endometrial thickness <7 mm in all prior IVF/ICSI cycles, normal endometrial appearance by either hysteroscopy, hysterosonography, or hysterosalpingography enrolled in this study. The conventional gonadotropin-releasing hormone (GnRH) protocol was used for ovarian stimulation. The patients were randomly divided into three groups: vaginal sildenafil (suppository-100 mg/daily), vaginal placebo/sildenafil (suppository-100 mg/daily), and vaginal placebo (suppository). Each patient underwent colour Doppler ultrasound on day 14 of their previous cycle to investigate any abnormalities in the uterus and adnexa. Endometrial thickness, echo pattern, uterine artery resistance, and pulsatility indices were recorded pre- and post-treatment. The primary outcome measures were implantation, chemical and clinical pregnancy rates. For data analysis, SPSS version 20 software was used. In all tests, the significance level was considered less than 0.05.
There was no significant difference between three groups in endometrial thickness on the hCG injection day. The chemical pregnancy in women who received sildenafil (alone or in combination with placebo) showed a two-fold increase in comparison to the placebo group. This increase was clinically meaningful, but according to sample size, it was statistically non-significant. The results of our study showed that the implantation was higher in women who received placebo/sildenafil compared to the other groups. The abortion rate was not statistically significant among the groups.
Vaginal sildenafil may conceivably improve chemical pregnancy rates in repeated IVF failure patients. Further randomized clinical trials using oral or vaginal sildenafil with higher sample size are recommended (Registration number: NCT03192709).
本研究旨在探讨阴道用西地那非对至少两次体外受精/卵胞浆内单精子注射（IVF/ICSI）尝试失败患者结局的影响。
在这项随机安慰剂对照试验研究中，共有66名年龄≤38岁、卵巢储备功能正常、既往连续两次IVF/ICSI尝试失败、既往所有IVF/ICSI周期中人类绒毛膜促性腺激素（hCG）日子宫内膜厚度<7mm、经宫腔镜检查、子宫超声检查或子宫输卵管造影显示子宫内膜外观正常的不孕女性纳入本研究。采用传统促性腺激素释放激素（GnRH）方案进行卵巢刺激。患者被随机分为三组：阴道用西地那非（栓剂 - 100mg/每日）、阴道用安慰剂/西地那非（栓剂 - 100mg/每日）和阴道用安慰剂（栓剂）。每位患者在其前一周期的第14天接受彩色多普勒超声检查，以调查子宫和附件的任何异常情况。记录治疗前后的子宫内膜厚度、回声模式、子宫动脉阻力和搏动指数。主要结局指标为着床率、生化妊娠率和临床妊娠率。数据分析使用SPSS 20版软件。在所有检验中，显著性水平设定为小于0.（此处原文有误，推测应为0.05）。
hCG注射日三组患者的子宫内膜厚度无显著差异。接受西地那非（单独或与安慰剂联合）的女性生化妊娠率与安慰剂组相比增加了两倍。这种增加具有临床意义，但根据样本量，在统计学上无显著差异。我们的研究结果表明，接受安慰剂/西地那非的女性着床率高于其他组。各组间流产率无统计学差异。
阴道用西地那非可能会提高反复IVF失败患者的生化妊娠率。建议进一步开展样本量更大的口服或阴道用西地那非随机临床试验（注册号：NCT03192709）。
