Effect of Oral Sildenafil Citrate on Improvement of Endometrial Thickness

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Oral Sildenafil Citrate: a Potential Approach for Improvement of Endometrial Thickness and Treatment of Unexplained Infertility in Women

Conditions
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Infertility, Female

Intervention / Treatment
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* Drug: Sildenafil Citrate
* Drug: Clomiphene Citrate 50mg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sildenafil and clomiphene citrate<br>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. | Drug: Sildenafil Citrate<br>* oral sildenafil (Respatio® 20mg )<br>* Other names: respatio;Drug: Clomiphene Citrate 50mg<br>* used for ovionulation induct<br>* Other names: technovula;|
| Other: clomiphene citrate alone<br>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. | Drug: Clomiphene Citrate 50mg<br>* used for ovionulation induct<br>* Other names: technovula;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy rate | Serum pregnancy test (positive/negative) | at the end of the cycle (28 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| endometrial thickness | measured by trans-vaginal ultrasound | 1 month | 
| ovulation rate | using trans-vaginal ultrasound | 1 month |