Effect of Oral Sildenafil Citrate on Improvement of Endometrial Thickness

Phase 2

Completed

• Conditions: Infertility, Female
• Interventions: Drug: Sildenafil Citrate; Drug: Clomiphene Citrate 50mg

• Registration Number: NCT05846906
• Lead Sponsor: Beni-Suef University

Brief Summary

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.

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 Timeline

• Study Start: 2021-10-01
• Primary Completion: 2022-04-30
• Study Completion: 2022-04-30
• Study First Submitted: 2023-04-15
• Study First Submitted QC: 2023-04-26
• Status Verified: 2023-05
• Study First Posted: 2023-05-06
• Last Update Submitted: 2023-05-25
• Last Update Posted: 2023-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 130

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sildenafil and clomiphene citrate	Clomiphene Citrate 50mg	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.
Sildenafil and clomiphene citrate	Sildenafil 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.
clomiphene citrate alone	Clomiphene Citrate 50mg	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.

Primary Outcome Measures

Name	Time	Method
Pregnancy rate	at the end of the cycle (28 days)	Serum pregnancy test (positive/negative)

Secondary Outcome Measures

Name	Time	Method
ovulation rate	1 month	using trans-vaginal ultrasound
endometrial thickness	1 month	measured by trans-vaginal ultrasound

Trial Locations

Locations (1)

Beni-suef university; 🇪🇬 Banī Suwayf, Egypt