Metformin in Infertile PCOS Patients

NCT00501904 | Unknown Phase 4 DMC

• 1 other identifier: 05/2006b
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Polycystic Ovary Syndrome

Keywords

Anovulation; Infertility; Metformin; PCOS; Treatment

Outcome Measures

Primary Outcomes (1)

• Pregnancy rate

  12 months

Secondary Outcomes (1)

• Ovulation rate Abortion rate Live-birth rate Adverse events

  21 months

Study Arms (2)

Group A

ACTIVE COMPARATOR

Short protocol

Drug: Metformin

Group B

ACTIVE COMPARATOR

Long protocol

Drug: Metformin

Interventions

Metformin DRUG

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Polycystic ovary syndrome (using NIH criteria)
• Anovulatory infertility (using WHO criteria)
• Ovulatory cycles under metformin (three cycles)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Magna Graecia: lead

Study Sites (1)

Pugliese Hospital

Catanzaro, Catanzaro, CZ, Italy, 88100, Italy

RECRUITING

Related Publications (2)

• Palomba S, Orio F Jr, Falbo A, Russo T, Tolino A, Zullo F. Clomiphene citrate versus metformin as first-line approach for the treatment of anovulation in infertile patients with polycystic ovary syndrome. J Clin Endocrinol Metab. 2007 Sep;92(9):3498-503. doi: 10.1210/jc.2007-1009. Epub 2007 Jun 26.

  PMID: 17595241 BACKGROUND

• Palomba S, Orio F Jr, Falbo A, Manguso F, Russo T, Cascella T, Tolino A, Carmina E, Colao A, Zullo F. Prospective parallel randomized, double-blind, double-dummy controlled clinical trial comparing clomiphene citrate and metformin as the first-line treatment for ovulation induction in nonobese anovulatory women with polycystic ovary syndrome. J Clin Endocrinol Metab. 2005 Jul;90(7):4068-74. doi: 10.1210/jc.2005-0110. Epub 2005 Apr 19.

  PMID: 15840746 BACKGROUND

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Anovulation; Infertility

Interventions

Metformin

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefano Palomba, MD

CONTACT

+39-0961-883234; stefanopalomba@tin.it

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 12, 2007
• First Posted: July 16, 2007
• Study Start: April 1, 2012
• Primary Completion: June 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 3, 2015

Record last verified: 2015-12

Locations

IT (1)