Treatment of Anovulatory Infertility in PCOS Patients
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|ClinicalTrials.gov Identifier: NCT00471523|
Recruitment Status : Completed
First Posted : May 10, 2007
Last Update Posted : May 10, 2007
|Condition or disease||Intervention/treatment||Phase|
|Infertility Polycystic Ovary Syndrome Anovulation||Drug: Clomiphene citrate Drug: Metformin||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clomiphene Citrate Versus Metformin as First-Line Approach for the Treatment of Anovulation in Infertile Patients With Polycystic Ovary Syndrome|
|Study Start Date :||May 2006|
|Study Completion Date :||March 2007|
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|