Clinical Trial: Treatment of Anovulatory Infertility in PCOS Patients
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Clomiphene Citrate Versus Metformin as First-Line Approach for the Treatment of Anovulation in Infertile Patients With Polycystic Ovary Syndrome
Brief Summary: 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.
Detailed Summary:
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.
Sponsor: University Magna Graecia
Current Primary Outcome: Pregnancy rate [ Time Frame: 10 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome: Same as current
Information By: University Magna Graecia
Dates:
Date Received: May 8, 2007
Date Started: May 2006
Date Completion:
Last Updated: May 8, 2007
Last Verified: May 2007
