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

Beni-Suef University

Status and phase: Completed; Phase 4

Conditions: Subfertility, Female

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05753098

REC-H-PhBSU-22022

Details and patient eligibility

About

. 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.

Full 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.

Enrollment: 148 patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• aged between 18 to 40 years
• unexplained infertility (primary or secondary)
• had a regular menstrual cycle;
• patent tubes;
• husbands with normal semen parameters.

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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148 participants in 3 patient groups

estrogen therapy in addition to clomiphene citrate

Experimental group

Description:

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.

Treatment:

Drug: Clomiphene Citrate 50mg

Drug: estrogen therapy

sildenafil in addition to clomiphene citrate

Experimental group

Description:

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

Treatment:

Drug: Clomiphene Citrate 50mg

Drug: Sildenafil

clomiphene citrate alone

Other group

Description:

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.

Treatment:

Drug: Clomiphene Citrate 50mg