Anovulatory
Conditions
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.
Interventions
DRUGSildenafil & clomiphene citrate
105 Patients will receive 25 mg sildenafil citrate 6hourly 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
DRUGclomiphene only
105 Patients will receive clomiphene citrate 100 mg/day (day 2 to 6) orally by the patient, for induction of ovulation
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 35 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical pregnancy rate | 6 weeks |
Secondary
| Measure | Time frame |
|---|---|
| endometrial thickness | 2 weeks |
| miscarriage rate | 13 weeks |
| ectopic pregnancy rate | 8 weeks |
| Side Effects of Vasodilators | 4 weeks |
Outcome results
None listed