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Tailored Versus Non-tailored Metformin Protocol for Ovulation Induction in Infertile Anovulatory PCOS Patients. A Randomized Controlled Clinical Study

Phase 4
18 Years
35 Years
Not Enrolling
Polycystic Ovary Syndrome

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Trial Information

Tailored Versus Non-tailored Metformin Protocol for Ovulation Induction in Infertile Anovulatory PCOS Patients. A Randomized Controlled Clinical Study

Infertile anovulatory PCOS eligible patients will be enrolled and randomly allocated to
receive tailored (tailored group) or non-tailored metformin treatment (non-tailored group).

Tailored metformin treatment will consist of incremental doses regimen starting from a
dosage of 850 mg daily (one tablet daily) with a weekly increase up to 2550 mg daily (three
tablets daily). The dosage of metformin will be reduced according to the appearance of
serous or affecting compliance drug-related side effects. Conversely, non-tailored metformin
treatment consisted of fixed doses regimen of 850 mg twice daily. For both groups, the
treatment will be of six months.

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.

Inclusion Criteria:

- Polycystic ovary syndrome (using NIH criteria)

- Anovulatory infertility (using WHO criteria)

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 drugs

- Previous 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:

Ovulation rate

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:

January 2008

Completion Date:

Related Keywords:

  • Polycystic Ovary Syndrome
  • Anovulation
  • metformin
  • PCOS
  • treatment
  • Polycystic Ovary Syndrome