Treatment of Anovulatory Infertility in PCOS Patients
Clomiphene citrate (CC) and metformin are two effective drugs used to induce ovulation in patients with polycystic ovary syndrome (PCOS), even if it is still unclear which compound between them should be initially administered. The aim of the study will be to compare in a clinical setting the efficacy of CC and metformin as first-line approaches for treating anovulation in infertile PCOS patients.
Polycystic Ovary Syndrome
Drug: Clomiphene citrate
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Clomiphene Citrate Versus Metformin as First-Line Approach for the Treatment of Anovulation in Infertile Patients With Polycystic Ovary Syndrome|
- Pregnancy rate [ Time Frame: 10 months ]
- Ovulation rate [ Time Frame: 6 months ]
- Abortion rate [ Time Frame: 10 months ]
- Time to first pregnancy [ Time Frame: 10 months ]
- Adverse events [ Time Frame: 10 months ]
- N. pregnancies/n. ovulatory cycles [ Time Frame: 10 months ]
|Study Start Date:||May 2006|
|Study Completion Date:||March 2007|
Eighty infertile anovulatory patients with PCOS will be allocated in two body mass index (BMI)- and age-matched groups (experimental and control groups).
Forty patients will receive the experimental treatment consisting of six months of 1700 mg/day metformin administration (experimental group), whereas other forty patients will receive CC administered using a traditional incremental-doses protocol (control group). In both groups, patients who will ovulate under treatment will continue the therapy for a total of six months.
During the study, the clinical and reproductive outcomes, and the adverse experience will be evaluated in each patient.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00471523
|Catanzaro, CZ, Italy, 88100|
|Principal Investigator:||Stefano Palomba, MD||Department of Obstetrics & Gynecology, University “Magna Graecia” of Catanzaro|
|Principal Investigator:||Achille Tolino, MD||Department of Obstetrics & Gynecology, University “Federico II” of Naples|
|Principal Investigator:||Francesco Orio, MD||Department of Endocrinology, University “Federico II” of Naples|