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Efficacy of Long- Versus Short-term Metformin Protocol in Infertile Anovulatory PCOS Patients

Phase 4
18 Years
35 Years
Open (Enrolling)
Polycystic Ovary Syndrome

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Trial Information

Efficacy of Long- Versus Short-term Metformin Protocol in Infertile Anovulatory PCOS Patients

Infertile PCOS patients having three ovulatory cycles under metformin, administered using
tailored protocol, will be enrolled and randomized in two groups (groups A and B). Patients
of group A will continue metformin administration for further three cycles followed by six
months of progestogens cyclically administered, whereas patients of group B will continue
metformin therapy for further nine cycles.

All patients eligible will undergo baseline assessment consisting of anthropometric,
hormonal, and ultrasonographic evaluations. During the study, the clinical and reproductive
outcomes, and the adverse experience will be evaluated in each patient.

Data will be analyzed using the intention-to-treat principle and a P value of 0.05 or less
will be considered significant. Continuous variables will be analyzed with the unpaired t
test and general linear model for repeated measures analysis with Bonferroni test for the
post-hoc analysis as required. For categorical variables, the Pearson chi-square and
Fisher's exact tests will be used. Cumulative pregnancy rate, our primary end-point, will be
calculated by the Kaplan-Maier method, and the differences between the two groups will be
assessed with the log-rank test. Cox proportional-hazards model will be used to calculate
the hazard ratio for new pregnancy in both groups.

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pregnancy rate

Outcome Time Frame:

12 months

Safety Issue:


Principal Investigator

Stefano Palomba, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Obstetrics & Gynecology, University "Magna Graecia" of Catanzaro


Italy: The Italian Medicines Agency

Study ID:




Start Date:

April 2012

Completion Date:

June 2014

Related Keywords:

  • Polycystic Ovary Syndrome
  • Anovulation
  • Infertility
  • Metformin
  • PCOS
  • Treatment
  • Polycystic Ovary Syndrome