Sildenafil Effect After Ovulation Induction

Study Overview
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Brief Summary
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100 women with infertility classified into 2 groups. Group A: Included 50 women who will be given clomiphene citrate 50mg (clomid) orally 2 times/day from 2rd-7th day of the cycle and sildeaynafil citrate 20mg tab from 7th-11th day of the same cycle orally 3 times/day. Group B: Included 50 women who will be given clomiphene citrate 50mg (clomid) orally 2 times/day from 2rd-7th day of the cycle and placebo tablets from 7th-11th day of the same cycle orally 3 times/day.

Detailed Description
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100 women with infertility classified into 2 groups. Group A: Included 50 women who will be given clomiphene citrate 50mg (clomid) orally 2 times/day from 2rd-7th day of the cycle and sildeaynafil citrate 20mg tab from 7th-11th day of the same cycle orally 3 times/day. Group B: Included 50 women who will be given clomiphene citrate 50mg (clomid) orally 2 times/day from 2rd-7th day of the cycle and placebo tablets from 7th-11th day of the same cycle orally 3 times/day. Folliculometry was assessed by: Transvaginal ultrasound: It was done on day 11th of the cycle to detect number of follicles and endometrial thickness. When the follicles reach ≥18 ml, injection of 5000 IU of HCG IM to trigger ovulation to both groups. Pregnancy was assessed by: Beta HCG test: (Radioimmunoassay)

Official Title
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Effect of Sildenafil Citrate on Pregnancy Rate in Women Undergoing Induction of Ovulation

Conditions
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Infertility

Intervention / Treatment
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* Drug: Clomiphene citrate
* Drug: sildenafil citrate
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infertile women whether it's primary or secondary infertility Woman's age: (18-35 years old) Menstrual cycle from (24-35 days) Normal semen analysis Exclusion Criteria: Age more than 35 years old Ovarian cysts Abnormal hormonal profile (e.g hyperprolactinaemia) Significant cardiovascular disease Serious liver disease or renal failure Poorly controlled diabetes mellitus

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: sildenafil citrate<br>50 women who will be given clomiphene citrate 50mg (clomid,) orally 2times/day from 2rd - 7th day of the cycle and sildenafil citrate 20mg tab from 7th-11th day of the same cycle orally 3times/day | Drug: Clomiphene citrate<br>* 50mg (clomid,) orally 2 times/day from 2nd- 7th day of the cycle<br>* Other names: clomid;Drug: sildenafil citrate<br>* 20mg tab from 7th-11th day of the same cycle orally 3times/day<br>* Other names: Viagra;|
| Placebo Comparator: placebo group<br>50 women who will be given clomiphene citrate 50mg (clomid,) orally 2times/day from 2rd- 7th day of the cycle and placebo tablets from 7th-11th day of the same cycle orally 3 times/day | Drug: Clomiphene citrate<br>* 50mg (clomid,) orally 2 times/day from 2nd- 7th day of the cycle<br>* Other names: clomid;Drug: Placebo<br>* tab from 7th-11th day of the same cycle orally 3times/day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy rate per cycle | Serum pregnancy test | 14 days after HCG triggering of ovulation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sildenafil Citrate, Induction of Ovulation, Pregnancy Rate