Effect of Oral Sildenafil Citrate on Improvement of Endometrial Thickness

Beni-Suef University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Infertility, Female

Treatments: Drug: Sildenafil Citrate; Drug: Clomiphene Citrate 50mg

Study type: Interventional

Funder types: Other

Identifiers

NCT05846906

REC-H-PhBSU-21015

Details and patient eligibility

About

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.

Full 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.

Enrollment: 130 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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130 participants in 2 patient groups

Sildenafil and clomiphene citrate

Experimental group

Description:

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.

Treatment:

Drug: Clomiphene Citrate 50mg

Drug: Sildenafil Citrate

clomiphene citrate alone

Other group

Description:

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.

Treatment:

Drug: Clomiphene Citrate 50mg