Effect of Oral Sildenafil Citrate on Improvement of Endometrial Thickness

May 25, 2023 updated by: Sara Abdallah Mohamed Salem, Beni-Suef University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Banī Suwayf, Egypt
        • Beni-Suef University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sildenafil and clomiphene citrate
Oral Clomiphene citrate (Tecnovula®) 50 mg was taken twice daily by the experimental group from day 2 through day 7 of the cycle, and oral sildenafil (Respatio® 20mg for 5 days) was taken from the last day of menstruation until reaching ovulation.
Drug: Sildenafil Citrate
oral sildenafil (Respatio® 20mg )
Other Names:
  • respatio
Drug: Clomiphene Citrate 50mg
used for ovionulation induct
Other Names:
  • technovula
Other: clomiphene citrate alone
Oral Clomiphene citrate (Tecnovula®) 50 mg was taken twice daily by the control group from day 2 through day 7 of the cycle in addition to a placebo tablet.
Drug: Clomiphene Citrate 50mg
used for ovionulation induct
Other Names:
  • technovula

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pregnancy rate
Time Frame: at the end of the cycle (28 days)
Serum pregnancy test (positive/negative)
at the end of the cycle (28 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
endometrial thickness
Time Frame: 1 month
measured by trans-vaginal ultrasound
1 month
ovulation rate
Time Frame: 1 month
using trans-vaginal ultrasound
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beni-Suef University

Investigators

  • Study Director: Beni-Suef University, Faculty of medicine Beni-Suef University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2021

Primary Completion (Actual)

April 30, 2022

Study Completion (Actual)

April 30, 2022

Study Registration Dates

First Submitted

April 15, 2023

First Submitted That Met QC Criteria

April 26, 2023

First Posted (Actual)

May 6, 2023

Study Record Updates

Last Update Posted (Actual)

May 30, 2023

Last Update Submitted That Met QC Criteria

May 25, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC-H-PhBSU-21015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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