Current Issue

Volume 13, Number 4, Jan-Mar 2020 Pages: 289-295

The Effect of Vaginal Sildenafil on The Outcome of Assisted Reproductive Technology Cycles in Patients with Repeated Implantation Failures: A Randomized Placebo-Controlled Trial


Ashraf Moini, M.D, 1, 2, 3, Fatemeh Zafarani, M.Sc, 4, Nadia Jahangiri, M.Sc, 1, Shahideh Jahanian Sadatmahalleh, Ph.D, 5, Marya Sadeghi, M.Sc, 1, Mohammad Chehrazi, Ph.D, 6, Firoozeh Ahmadi, M.D, 4, *,
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
Department of Obstetrics and Gynaecology, Arash Women's Hospital, Tehran University of Medical Sciences, Tehran, Iran
Department of Reproductive Imaging, Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran
Department of Midwifery and Reproductive Health, Faculty of Medical Sciences, Tarbiat Modares University, Tehran, Iran
Department of Biostatistics and Epidemiology, School of Medicine, Babol University of Medical Sciences, Babol, Iran
*Corresponding Address: P.O.Box: 16635-148 Department of Reproductive Imaging Reproductive Biomedicine Research Center Royan Institute for Reproductive Biomedicine ACECR Tehran Iran Email:f_ahmadi@royaninstitute.org

Abstract

Background

The aim of this study was to investigate the effects of vaginal sildenafil on the outcome of patients with at least two unsuccessful in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) attempts.

Materials and Methods

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 appear- ance 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.

Results

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.

Conclusion

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 (Registra- tion number: NCT03192709).