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.
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
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
"Pugliese Hospital"
Catanzaro, CZ, Italy
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
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