Letrozole Versus Combined Metformin and Clomiphene Citrate for Ovulation Induction in Clomiphene-Resistant Women With Polycystic Ovary Syndrome
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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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).
No
Hatem Abu Hashim, MD. MRCOG
Principal Investigator
Mansoura University Hospitals
Egypt: Institutional Review Board
MU- 059
NCT00911313
June 2006
January 2009
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