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

Study Overview
=================
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.

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

Conditions
-----------------
Subfertility, Female

Intervention / Treatment
-----------------
* Drug: estrogen therapy
* Drug: Sildenafil
* Drug: Clomiphene Citrate 50mg


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: estrogen therapy in addition to clomiphene citrate<br>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. | Drug: estrogen therapy<br>* oral estradiol valerate<br>* Other names: white tablet of cycloprogynova;Drug: Clomiphene Citrate 50mg<br>* used for ovulation induction<br>* Other names: Technovula;|
| Experimental: sildenafil in addition to clomiphene citrate<br>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 | Drug: Sildenafil<br>* PDE5 inhibitor<br>* Other names: Respatio;Drug: Clomiphene Citrate 50mg<br>* used for ovulation induction<br>* Other names: Technovula;|
| Other: clomiphene citrate alone<br>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. | Drug: Clomiphene Citrate 50mg<br>* used for ovulation induction<br>* Other names: Technovula;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pregnancy rates | measure B HCG and detect number of cases get pregnant in each cycle 28 days | at the end of each of 3 cycles (28 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ovulation | measuring dominant follicle starting from D9 of the cycle till reaching 18-20mm | 3 months |