PCOSMIC Trial - PolyCystic Ovary Syndrome, Metformin for Infertility With Clomiphene (PCOSMIC)

November 20, 2008 updated by: University of Auckland, New Zealand

Multi-Centre Randomised Controlled Trial of the Effectiveness of Metformin and Clomiphene Citrate for Treating Anovulatory Infertility in Women With Polycystic Ovary Syndrome

  1. Metformin increases the pregnancy rate when added to the standard treatment of anovulatory polycystic ovary syndrome (PCOS).
  2. Metformin in combination with clomiphene, is more effective than clomiphene alone or metformin alone improves fertility outcomes in women with PCOS of reasonably healthy body weight (BMI </= 32).
  3. Metformin improves fertility outcomes in women with BMI > 32 with PCOS.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

171

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • New Zealand
      • Auckland, New Zealand
        • University of Auckland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 39 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women between the age of 18 and 39 years inclusive.
  • Anovulatory infertility of duration at least 12 months.
  • Polycystic ovary syndrome, based on Rotterdam consensus criteria.
  • Normal serum prolactin, thyroid function and 17-hydroxyprogesterone.
  • Normal serum prolactin, thyroid function and 17-hydroxyprogesterone;

Exclusion Criteria:

  • Presence of any other significant infertility factor including male factor, known tubal disease or history of an ectopic pregnancy, known endometriosis affecting the fallopian tubes or ovaries.
  • Already taking oral hypoglycaemics.
  • Diabetics receiving treatment.
  • Renal impairment
  • Chronic hepatic disease
  • Cardiac Disease
  • Alcohol dependency
  • Pre-disposition to lactic acidosis
  • Previous ovarian drilling procedure, gonadotrophin injection therapy, IUI (intrauterine insemination) or IVF ( in vitro fertilisation).

  • For those women who have had previous fertility treatment, the following would be excluded:

    • Women who have had > 5 cycles of clomiphene citrate
    • Women who have had > 5 months metformin treatment previously
    • Women who have proven to be resistant to 100mg or more of clomiphene citrate.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BMI > 32
Women with BMI > 32
Drug: Metformin
500mg tds for 6 months
Drug: Placebo
One tablet tds for 6 months
Experimental: BMI </= 32
Women with BMI </= 32
Drug: Metformin
500mg tds for 6 months
Drug: Metformin + Clomiphene
500mg tds + Ovulatory dose for 6 months
Drug: Clomiphene
Ovulatory dose for 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical pregnancy
Time Frame: within 6 calendar months of randomisation
within 6 calendar months of randomisation

Secondary Outcome Measures

Outcome Measure
Adverse events
Live birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Auckland, New Zealand

Collaborators

Auckland Medical Research Foundation
Mercia Barnes Trust of the Royal Australian and New Zealand College of Obstetricians and Gynaecologists

Investigators

  • Principal Investigator: Neil P Johnson, FRANZCOG, University of Auckland, fertility Plus & Repromed Auckland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2003

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

November 20, 2008

First Submitted That Met QC Criteria

November 20, 2008

First Posted (Estimate)

November 21, 2008

Study Record Updates

Last Update Posted (Estimate)

November 21, 2008

Last Update Submitted That Met QC Criteria

November 20, 2008

Last Verified

November 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UAuckland

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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