Metformin Addition to Gonadotropins Ovarian Stimulation in High Responder Patients With PCOS Undergoing In-vitro Fertilization
Infertile young non-obese insulin-resistant patients with PCOS who had a background of the
first IVF treatment cycle cancelled because of high risk for OHSS will be enrolled and
randomized in two treatment arms.
In their second IVF attempt, the experimental group will receive metformin (500 mg, 3 times
daily) pre-treatment for two weeks and co-administration during gonadotropins ovarian
stimulation; the control group will be treated with placebo (2 cps daily) pre-treatment and
co-administration by using the same schedule of the experimental group. In all patients,
ovarian stimulation will be carried out with a personalized step-down gonadotropin in
association with a minidose flare-up GnRH agonist protocol.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Rate of OHSS
University Magna Graecia
Italy: The Italian Medicines Agency