Clomiphene Citrate Versus Metformin as First-Line Approach for the Treatment of Anovulation in Infertile Patients With Polycystic Ovary Syndrome
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Infertility
- Sponsor
- University Magna Graecia
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Pregnancy rate
- Status
- Completed
- Last Updated
- 18 years ago
Overview
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 Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Anovulatory infertility related to polycystic ovary syndrome
Exclusion Criteria
- •Neoplastic, metabolic, hepatic, and cardiovascular disorders or other concurrent medical illnesses
- •Hypothyroidism, hyperprolactinemia, Cushing's syndrome, and non-classical congenital adrenal hyperplasia
- •Current or previous (within the last six months) use of oral contraceptives, glucocorticoids, antiandrogens, ovulation induction agents, antidiabetic and anti-obesity drugs or other hormonal drugs.
- •Organic pelvic diseases
- •Previous pelvic surgery
- •Suspected peritoneal factor infertility
- •Tubal or male factor infertility or sub-fertility
Outcomes
Primary Outcomes
Pregnancy rate
Time Frame: 10 months
Secondary Outcomes
- Abortion rate(10 months)
- Time to first pregnancy(10 months)
- Adverse events(10 months)
- Ovulation rate(6 months)
- N. pregnancies/n. ovulatory cycles(10 months)