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NCT Number: NCT05846906

Effect of Oral Sildenafil Citrate on Improvement of Endometrial Thickness

One hundred thirty women with unexplained infertility participated in a prospective clinical study. Patients were assigned at random to one of two groups. The first group (n=65) served as the study group and was given clomiphene citrate 50 mg (Tecnovula®, Techno Pharmaceuticals, Egypt) and sildenafil (Respatio®, Pharma right group, Egypt) 20 mg tablets. The second group (n=65) served as a control and received a placebo tablet in addition to the standard treatment of clomiphene citrate 50 mg (Tecnovula®). A transvaginal ultrasound was performed on all of the patients to assess ovulation.

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Key information

Conditions

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

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Beni-suef university

Banī Suwayf, Egypt

About this study

One hundred thirty women with unexplained infertility participated in a prospective clinical study. Patients were assigned at random to one of two groups. The first group (n=65) served as the study group and was given clomiphene citrate 50 mg (Tecnovula®, Techno Pharmaceuticals, Egypt) orally twice daily from the second day of their cycle through the seventh day and sildenafil (Respatio®, Pharma right group, Egypt) 20 mg tablets from the end of menstruation through ovulation. The second group (n=65) served as a control and received a placebo tablet in addition to the standard treatment of clomiphene citrate 50 mg (Tecnovula®). A transvaginal ultrasound was performed on all of the patients to assess ovulation, follicle count, and pregnancy. Consequences, including miscarriage, ectopic pregnancy, and multiple pregnancies, were monitored.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • ages of 18 to 40
  • patent tubes
  • unexplained infertility
  • regular menstrual cycle
  • husband with normal sperm parameters

Exclusion criteria

  • hypotension
  • cardiovascular, renal and hepatic diseases
  • uncontrolled diabetes mellitus
  • anovulatory infertility
  • abnormal thyroid functions
  • ovarian cysts
  • patients taking nitrates
  • pelvic adhesions
  • abnormal hormonal profile.
  • hyperprolactinemia
  • multiple uterine fibroids
  • adenomyosis and endometriosis suspicion

Treatment and study plan

sildenafil citrate

Drug

oral sildenafil (Respatio® 20mg )

Other names: respatio

Clomiphene Citrate 50mg

Drug

used for ovionulation induct

Other names: technovula

Primary outcomes

  1. Pregnancy rate

    Time frame: at the end of the cycle (28 days)

    Serum pregnancy test (positive/negative)

Secondary outcomes

  1. endometrial thickness

    Time frame: 1 month

    measured by trans-vaginal ultrasound

  2. ovulation rate

    Time frame: 1 month

    using trans-vaginal ultrasound

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Registry information

Official study title

Oral Sildenafil Citrate: a Potential Approach for Improvement of Endometrial Thickness and Treatment of Unexplained Infertility in Women

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 6, 2023
Registry last updated
May 30, 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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