Metformin in Infertile PCOS Patients

• Status: Unknown status
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

Metformin, an oral biguanide administrated for treating type-2 diabetes mellitus, is a safe and effective drug recently experimented also in patients with polycystic ovary syndrome (PCOS). The administration of metformin induces ovulatory cycles in CC-resistant or -nonresistant patients with PCOS, and improves the ovulation rate as an additional treatment in women who received CC.

To date, it is unknown the best protocol for metformin administration. In particular, it is not known how long patients who ovulate under metformin should continue treatment before switching to second-line ovulation induction therapy. In this regard, in a recent study by the Kaplan-Meier survival analysis we demonstrated that the first pregnancy occurred late after metformin with an estimated median of seven months.

Based on these considerations, the aim of the present study will be to evaluate the clinical efficacy of metformin according to its duration of administration in infertile PCOS patients ovulating under treatment.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Magna Graecia
• Treatments: Metformin

Criteria

Inclusion Criteria:

• Polycystic ovary syndrome (using NIH criteria)

• Anovulatory infertility (using WHO criteria)

• Ovulatory cycles under metformin (three cycles)

Exclusion Criteria:

• Age <18 or >35 years

• Severe obesity (BMI >35)

• 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, antidiabetic and anti-obesity drugs or other hormonal drugsPrevious use of ovulation induction agents

• Intention to start a diet or a specific program of physical activity

• Organic pelvic diseases

• Previous pelvic surgery

• Suspected peritoneal factor infertility

• Tubal or male factor infertility or sub-fertility