The purpose of this study is to compare and determine the efficacy of letrozole administration to that of combined metformin and Clomiphene in infertile women with polycystic ovary syndrome (PCOS) not responding to treatment with Clomiphene alone.
Withdrawal bleeding was achieved using 10 mg of dydrogesterone tablets for 10 days before stimulation. In the letrozole group, 2.5 mg of letrozole oral tablets (Femara; Novartis Pharma Services, Switzerland) daily from day 3 of the menses for 5 days, whereas all patients in the combined metformin-CC group) received metformin HCl \[Cidophage®; Chemical Industries Development(CID), Cairo, Egypt\], 500 mg three times daily for 6-8 weeks. Then after the end of this period, they received 150 mg CC (Clomid®; Global Napi Pharmaceuticals, Cairo, Egypt) for 5 days starting from day 3 of menstruation. Patients continued treatment for three successive cycles using the same protocol. Metformin was stopped only when pregnancy was documented.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
250
2.5 mg letrozole daily from day 3 of the menses for 5 days
metformin HCl 1500 daily for 6-8 weeks
150 mg CC for 5 days starting from day 3 of menstruation
Mansoura University Hospitals,OB/GYN department
Al Mansurah, Dakahlia Governorate, Egypt
Principally the ovulation rate as well as the number of growing and mature follicles, serum E2 (pg/ml), serum P (ng/mL), and endometrial thickness (mm).
The occurrence of pregnancy and miscarriage.
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