Metformin Administration in Infertile Anovulatory PCOS Patients
Status:
Withdrawn
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
In a recent prospective study evaluating the efficacy of 1700 mg/day metformin as first-line
approach for infertile anovulatory patients with PCOS, we identified predictors for metformin
efficacy. Our analysis demonstrated that body mass index (BMI) and insulin resistance were
the strongest predictors for both ovulation and pregnancy. In particular, adjusting the data
for insulin resistance, a trend in reduced effectiveness was observed with increasing BMI. On
the other hand, adjusting the data for BMI, a trend in improved efficacy was detected for
higher insulin resistance degrees.
To date, no dose-finding study is currently available in literature evaluating the best dose
of metformin to administer. In addition, very few data regarding the best protocol for
metformin treatment also are available. However, in order to reduce drug-related side effects
incidence due to start-up syndrome, metformin is generally administrated with meals at
incremental weekly doses until the maximum dosage ranging from 500 to 2550 mg daily; the
doses are reduced if side effects appear. This commonly accepted protocol has not been
supported by scientific evidences.
The aim of the present study will be to evaluate in a clinical setting the compliance, the
safety and the effectiveness of two schedules for metformin administration in infertile
anovulatory PCOS patients.