Metformin Administration in Infertile Anovulatory PCOS Patients
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Purpose
In a recent prospective study evaluating the efficacy of 1700 mg/day metformin as first-line approach for infertile anovulatory patients with PCOS, we identified predictors for metformin efficacy. Our analysis demonstrated that body mass index (BMI) and insulin resistance were the strongest predictors for both ovulation and pregnancy. In particular, adjusting the data for insulin resistance, a trend in reduced effectiveness was observed with increasing BMI. On the other hand, adjusting the data for BMI, a trend in improved efficacy was detected for higher insulin resistance degrees.
To date, no dose-finding study is currently available in literature evaluating the best dose of metformin to administer. In addition, very few data regarding the best protocol for metformin treatment also are available. However, in order to reduce drug-related side effects incidence due to start-up syndrome, metformin is generally administrated with meals at incremental weekly doses until the maximum dosage ranging from 500 to 2550 mg daily; the doses are reduced if side effects appear. This commonly accepted protocol has not been supported by scientific evidences.
The aim of the present study will be to evaluate in a clinical setting the compliance, the safety and the effectiveness of two schedules for metformin administration in infertile anovulatory PCOS patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Polycystic Ovary Syndrome |
Drug: Metformin |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Tailored Versus Non-tailored Metformin Protocol for Ovulation Induction in Infertile Anovulatory PCOS Patients. A Randomized Controlled Clinical Study |
- Ovulation rate
- Adverse events
- Adherence rate
- Pregnancy rate
- Abortion rate
- Live-birth rate
| Enrollment: | 0 |
| Study Start Date: | January 2008 |
| Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Group B
Non-tailoring
|
Drug: Metformin |
|
Active Comparator: Group A
Tailoring
|
Drug: Metformin |
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 35 Years |
| Genders Eligible for Study: | Female |
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
Contacts and Locations| Italy | |
| Pugliese Hospital | |
| Catanzaro, Catanzaro, CZ, Italy, 88100 | |
| 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 |
More Information
No publications provided
| Responsible Party: | Stefano Palomba, Associate Professor, University Magna Graecia |
| ClinicalTrials.gov Identifier: | NCT00501787 History of Changes |
| Other Study ID Numbers: | 05/2006d |
| Study First Received: | July 12, 2007 |
| Last Updated: | April 5, 2013 |
| Health Authority: | Italy: The Italian Medicines Agency |
Keywords provided by University Magna Graecia:
|
Anovulation metformin PCOS treatment |
Additional relevant MeSH terms:
|
Polycystic Ovary Syndrome Ovarian Cysts Cysts Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female |
Gonadal Disorders Endocrine System Diseases Metformin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013