Effect of Sildenafil Citrate Compared to Estrogen as Adjuvant Therapy for Unexplained Infertility
- Conditions
- Subfertility, Female
- Interventions
- Registration Number
- NCT05753098
- Lead Sponsor
- Beni-Suef University
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 148
- aged between 18 to 40 years
- unexplained infertility (primary or secondary)
- had a regular menstrual cycle;
- patent tubes;
- husbands with normal semen parameters.
- hypotension;
- cardiovascular, hepatic, and renal diseases;
- uncontrolled diabetes mellitus;
- anovulatory infertility;
- ovarian cysts;
- pelvic adhesions;
- hyperprolactinemia;
- abnormal thyroid functions;
- multiple uterine fibroids;
- patients on nitrates;
- suspicion of endometriosis and adenomyosis,
- subjects have known to receive any treatment for fertility in the last six months
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description sildenafil in addition to clomiphene citrate Clomiphene Citrate 50mg received clomiphene citrate 50 mg (Tecnovula®) orally twice daily from the 2nd to 7th day of the cycle as and Sildenafil (Respatio® 20mg film coated tablets for 5 days) from last day of menstruation till reaching optimal size of follicle and endometrial thickness estrogen therapy in addition to clomiphene citrate Clomiphene Citrate 50mg received clomiphene citrate 50 mg (Tecnovula®) orally twice daily from the 2nd to 7th day of the cycle and estrogen (Cyclopregnova® 2mg, white tablets, BAYER Schering pharma), one tablet every 12 hour from day 8th till triggering of ovulation. clomiphene citrate alone Clomiphene Citrate 50mg received clomiphene citrate 50 mg (Tecnovula®) orally twice daily from the 2nd to 7th day of the cycle as in the first and second groups in addition to placebo tablet. estrogen therapy in addition to clomiphene citrate estrogen therapy received clomiphene citrate 50 mg (Tecnovula®) orally twice daily from the 2nd to 7th day of the cycle and estrogen (Cyclopregnova® 2mg, white tablets, BAYER Schering pharma), one tablet every 12 hour from day 8th till triggering of ovulation. sildenafil in addition to clomiphene citrate Sildenafil received clomiphene citrate 50 mg (Tecnovula®) orally twice daily from the 2nd to 7th day of the cycle as and Sildenafil (Respatio® 20mg film coated tablets for 5 days) from last day of menstruation till reaching optimal size of follicle and endometrial thickness
- Primary Outcome Measures
Name Time Method pregnancy rates at the end of each of 3 cycles (28 days) measure B HCG and detect number of cases get pregnant in each cycle 28 days
- Secondary Outcome Measures
Name Time Method ovulation 3 months measuring dominant follicle starting from D9 of the cycle till reaching 18-20mm
Trial Locations
- Locations (1)
Beni-suef university
🇪🇬Banī Suwayf, Egypt