drugset / Trial / NCT02551367

Letrozole Versus Clomiphene Citrate for Ovulation Induction in Women With Poly Cystic Ovary Syndrome ( PCOS )

NCT02551367

RandomizedParallel-groupSingle-blindTreatment

Summary

110 infertile women diagnosed as polycystic ovary syndrome (PCOS) at the age group of 20-35 distributed randomly : * 55 women will receive letrozole 2.5mg twice daily orally from the 2nd day to the 6thday of the cycle for three successive cycles. * 55 women will receive clomiphene citrate 50 mg twice daily orally from the 2nd day to the 6thday of the cycle for three successive cycles. Patients will be subjected to: Complete history taking: 1. Details about name, age 2. Menstrual history with determination of menarche 3. Amenorrhea or oligomenorrhea , Regularity of the cycle 4. History of endocrine disease. 5. History of previous operations. * Physical examination: * General examination: With special concern to: --Acne. --Hirsutism . --Weight. --Height --BMI was determined : Wt. in kg ـــــــــــــــــــ = ) Height in m)2 \- Abdominal examination : * for scar of previous pelvic or abdominal operations . * Pelvic examination : * vaginal examination for enlarged cystic ovaries. * ultrasound for diagnosis of pcos. PARAMETERS: (1) rate of ovulation (primary parameter). (2) serum progesterone level on day 21. (3) number of mature follicles produced per cycle. (4) mean endometrial thickness. (6) chemical pregnancy. (7) ongoing pregnancy

Timeline

Start
2015-10
Primary completion
2016-05
Completion
2016-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Clomiphene Other / unclassified 50 mg Oral
Subject Letrozole Other / unclassified 2.5 mg Oral
Background human chorionic gonadotropin Protein / enzyme biologic 10000 iu Intramuscular