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Completed

NCT Number: NCT05753098

Effect of Sildenafil Citrate Compared to Estrogen as Adjuvant Therapy for Unexplained Infertility

. This study aimed to determine and compare the effect of vaginal sildenafil citrate and estradiol valerate on endometrial thickness, blood flow and pregnancy rates in infertile women.

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Key information

Conditions

Subfertility, Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infertility Infertility, Female Urogenital Diseases

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Beni-suef university

Banī Suwayf, Egypt

About this study

The study is a randomized controlled trial that was carried on 148 infertile women with unexplained infertility. Patients were divided into 3 groups. Group 1 included 48 patients who received oral estradiol valerate (Cyclo-Progynova 2mg, from day 8th till triggering of ovulation), another 50 patients in group 2 received oral Sildenafil (Respatio 20mg/12hr film coated tablets for 5 days starting from last day of menstruation till ovulation), while group 3 was the control one who included 50 patients were given ovulation induction with CC 50mg/12hr from 2nd to 7th day of cycle. Every patient underwent a transvaginal ultrasound to determine ovulation, number of follicles, and pregnancy rates. Miscarriage, ectopic pregnancy, and multiple pregnancies were tracked for 3 months, as were any adverse consequences.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • aged between 18 to 40 years
  • unexplained infertility (primary or secondary)
  • had a regular menstrual cycle;
  • patent tubes;
  • husbands with normal semen parameters.

Exclusion criteria

  • hypotension;
  • cardiovascular, hepatic, and renal diseases;
  • uncontrolled diabetes mellitus;
  • anovulatory infertility;
  • ovarian cysts;
  • pelvic adhesions;
  • hyperprolactinemia;
  • abnormal thyroid functions;
  • multiple uterine fibroids;
  • patients on nitrates;
  • suspicion of endometriosis and adenomyosis,
  • subjects have known to receive any treatment for fertility in the last six months

Treatment and study plan

estrogen therapy

Drug

oral estradiol valerate

Other names: white tablet of cycloprogynova

Sildenafil

Drug

PDE5 inhibitor

Other names: Respatio

Clomiphene Citrate 50mg

Drug

used for ovulation induction

Other names: Technovula

Primary outcomes

  1. pregnancy rates

    Time frame: at the end of each of 3 cycles (28 days)

    measure B HCG and detect number of cases get pregnant in each cycle 28 days

Secondary outcomes

  1. ovulation

    Time frame: 3 months

    measuring dominant follicle starting from D9 of the cycle till reaching 18-20mm

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Registry information

Official study title

Effect of Sildenafil Citrate Compared to Estrogen as Adjuvant Therapy on Improvement of Endometrial Thickness and Treatment of Unexplained Infertility

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 3, 2023
Registry last updated
Apr 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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