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Metformin in Infertile PCOS Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by University Magna Graecia
Sponsor:
Information provided by (Responsible Party):
Stefano Palomba, University Magna Graecia
ClinicalTrials.gov Identifier:
NCT00501904
First received: July 12, 2007
Last updated: April 5, 2013
Last verified: April 2013

July 12, 2007
April 5, 2013
April 2012
December 2013   (final data collection date for primary outcome measure)
Pregnancy rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Pregnancy rate [ Time Frame: 12 months ]
Complete list of historical versions of study NCT00501904 on ClinicalTrials.gov Archive Site
Ovulation rate Abortion rate Live-birth rate Adverse events [ Time Frame: 21 months ] [ Designated as safety issue: No ]
Ovulation rate Abortion rate Live-birth rate Adverse events [ Time Frame: 21 months ]
Not Provided
Not Provided
 
Metformin in Infertile PCOS Patients
Efficacy of Long- Versus Short-term Metformin Protocol in Infertile Anovulatory PCOS Patients

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Polycystic Ovary Syndrome
Drug: Metformin
  • Active Comparator: Group A
    Short protocol
    Intervention: Drug: Metformin
  • Active Comparator: Group B
    Long protocol
    Intervention: Drug: Metformin

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
June 2014
December 2013   (final data collection date for primary outcome measure)

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
Female
18 Years to 35 Years
No
Contact: Stefano Palomba, MD +39-0961-883234 stefanopalomba@tin.it
Italy
 
NCT00501904
05/2006b
Yes
Stefano Palomba, University Magna Graecia
University Magna Graecia
Not Provided
Principal Investigator: Stefano Palomba, MD Department of Obstetrics & Gynecology, University "Magna Graecia" of Catanzaro
Principal Investigator: Francesco Orio, MD Department of Endocrinology, University "Federico II" of Naples
Principal Investigator: Achille Tolino, MD Department of Obstetrics & Gynecology, University "Federico II" of Naples
University Magna Graecia
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP