The Effect of Sildenafil Citrate on the Success Rate of Ovulation Induction Using Clomiphene
Phase 2
Completed
- Conditions
- Anovulatory
- Interventions
- Registration Number
- NCT02663830
- Lead Sponsor
- Ain Shams University
- Brief Summary
The aim of the study is to evaluate the effect of sildenafil citrate on the pregnancy rate in women undergoing induction of ovulation using clomiphene citrate.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 210
Inclusion Criteria
- Women age 21-35 years.
- Anovulatory cycles due to polycystic ovaries syndrome.
- Non-smokers.
- Free of major medical illness
Exclusion Criteria
- Women with myoma or adenomyosis
- Women with congenital uterine anomaly.
- Chronic use of any medications including non-steroidal anti-inflammatory drugs.
- Associated cases of infertility other than PCOs (male factor, tubal factor,....).
- Asherman syndrome.
- Cases with endometrial hyperplasia.
- Cases with endometrial polyp
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description (Sildenafil & clomiphene citrate group) Sildenafil & clomiphene citrate 105 Patients will receive 25 mg sildenafil citrate 6 hourly orally (day 6 to the end of the cycle), and clomiphene citrate 100 mg/day (day 2 to 6) orally by the patient, for induction of ovulation clomiphene only clomiphene only 105 patients will receive only clomiphene citrate 100mg/day (day 2 to 6) orally (2 tablets at same time daily).
- Primary Outcome Measures
Name Time Method Clinical pregnancy rate 6 weeks
- Secondary Outcome Measures
Name Time Method miscarriage rate 13 weeks endometrial thickness 2 weeks Side Effects of Vasodilators 4 weeks ectopic pregnancy rate 8 weeks