Sildenafil and Outcome of IVF/ICSI Cycles

Summary

Adequate growth of the endometrium is crucial for implantation. Accordingly, the pregnancy success rate of patients with a thin endometrium is low. Furthermore, there is a little information about the factors responsible for impaired endometrial growth in patients with a thin endometrium. The researches have revealed that nitric oxide (NO) release can cause relaxation of vascular smooth muscle through a cyclic guanyl monophosphate (cGMP)-mediated pathway. Sildenafil is a type 5-specific Phosphodiesterase inhibitor that augments the vasodilatory effects of NO on vascular smooth muscle by preventing the degradation of cGMP and could improve blood flow and endometrial thickness. This study is designed to evaluate the effect of vaginally administered sildenafil suppositories on IVF/ICSI outcome of infertile patients with repeated IVF/ICSI failures.

Conditions

• Infertility, Female

Interventions

DRUG

Sildenafil vaginal suppositories

Sildenafil vaginal suppositories (100 mg/day) from the start of HMG administration day until the day of oocyte retrieval.

OTHER

vaginal placebo

Daily vaginal placebo from the start of HMG administration day until 2 days before the hCG injection day, then will be switched to vaginal sildenafil suppositories (100 mg/day) until the day of oocyte retrieval.

OTHER

vaginal placebo

Daily vaginal placebo from the start of HMG administration day until the day of oocyte retrieval.

Sponsors & Collaborators

• Tehran University of Medical Sciences

  collaborator OTHER

• Royan Institute

  lead OTHER_GOV

Principal Investigators

• Hamid Gourabi, PhD · Head of Royan Institute

• Ashraf Moieni, MD · Department of Endocrinology and Female Infertility, Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran.

• Firoozeh Ahmadi, MD · Department of Endocrinology and Female Infertility, Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran.

• Fatemeh Zafarani, MSc · Department of Endocrinology and Female Infertility, Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran.

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

16 Years

Max Age

38 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-02-28

Primary Completion

2017-08-31

Completion

2017-09-30

Countries

• Iran

Study Locations