NCT05753098

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 148 (actual)
• Sponsor: Beni-Suef University · Academic / Other
• Sex: Female
• Age: 20 Years – 40 Years
• Healthy volunteers: Accepted

Summary

. 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.

Detailed description

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.

Conditions

• Subfertility, Female

Interventions

Type	Name	Description
DRUG	estrogen therapy	oral estradiol valerate
DRUG	Sildenafil	PDE5 inhibitor
DRUG	Clomiphene Citrate 50mg	used for ovulation induction

Timeline

• Start date: 2021-01-15
• Primary completion: 2023-01-31
• Completion: 2023-01-31
• First posted: 2023-03-03
• Last updated: 2023-04-28

Locations

1 site across 1 country: Egypt