Metformin Treatment Before in Vitro Fertilization (IVF) in Women With Ultrasound Evidence of Polycystic Ovaries

January 8, 2010 updated by: University of Oxford

Metformin Treatment Before IVF in Women With Ultrasound Evidence of Polycystic Ovaries; a Prospective, Randomised, Double Blind, Placebo Study

The aim of study was to investigate whether pre-treatment with metformin before and during IVF increases the live birth rate compared to placebo in women with sonographic evidence of polycystic ovaries (PCO), but without any clinical manifestations of polycystic ovary syndrome (PCOS).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

134

Phase

  • Not Applicable

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

  • United Kingdom
      • London, United Kingdom
        • IVF Hammersmith
      • Nottingham, United Kingdom
        • Nuture IVF Unit
      • Oxford, United Kingdom, OX39DU
        • Oxford Fertility Unit

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

No older than 38 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women attending with ovulatory PCO due to undergo IVF/ICSI treatment.
  • First or second cycle of IVF/ICSI.
  • If previously on metformin, a minimum one month washout period was required.
  • Polycystic ovaries diagnosed by ultrasound presence of ≥12 follicles measuring 2-9 mm in diameter in at least one ovary and/or increased ovarian volume (≥10 ml).
  • Written informed consent.

Exclusion Criteria:

  • Clinical manifestations of PCOS, including any of the following:

    1. Oligo- or amenorrhoea with cycles ≥42 days apart.
    2. Anovulation with mid-luteal progesterone <16 nmol/L.
    3. Biochemical hyperandrogenism with serum testosterone ≥3.5 nmol/L and/or free androgen index >5 (FAI = [total testosterone/SHBG] x 100).
    4. Clinical hyperandrogenism with hirsutism or acne requiring treatment at least weekly.
  • Age >38 years.
  • BMI >35 kg/m2.
  • Basal FSH >12 IU/L.
  • Liver disease or ALT >80 IU/L.
  • Renal disease, or creatinine >130 nmol/L.
  • Alcoholism or drug abuse.
  • Diabetes mellitus (evaluated by fasting glucose >6.7mmol/L).
  • Per oral steroid treatment in last month.
  • Cimetidine, anticoagulation, erythromycin, or other macrolides in last month.
  • Hyperprolactinemia (Prolactin >700 mIU/L).
  • Abnormal thyroid function tests (TSH outside of laboratory normal range).
  • Congenital adrenal hyperplasia.

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Metformin
Drug (including placebo)
Drug: Metformin
Women were randomised to receive either metformin or placebo starting three weeks before initiation of a GnRH agonist during an IVF treatment cycle (seven weeks prior to oocyte collection and then stopped at oocyte collection). Seventy identical packs of metformin and 70 identical packs of placebo were supplied by DHP Ltd, Crickhowell, Powys (UK) a commercial clinical trial supplier. The randomisation service was provided by DHP Ltd.
Placebo Comparator: Sugar pill
Drug (including placebo)
Drug: Placebo
Women were randomised to receive either metformin or placebo starting three weeks before initiation of a GnRH agonist during an IVF treatment cycle (seven weeks prior to oocyte collection and then stopped at oocyte collection). Seventy identical packs of metformin and 70 identical packs of placebo were supplied by DHP Ltd, Crickhowell, Powys (UK) a commercial clinical trial supplier. The randomisation service was provided by DHP Ltd.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Live birth rate
Time Frame: End of pregnancy
End of pregnancy

Secondary Outcome Measures

Outcome Measure
Time Frame
Severe ovarian hyperstimulation syndrome
Time Frame: 2 months
2 months

Collaborators and Investigators

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

Sponsor

University of Oxford

Collaborators

University of Nottingham
Imperial College London

Investigators

  • Study Director: Tim J Child, MA MD MRCOG, University of Oxford
  • Principal Investigator: Alexander G Swanton, MBBS MRCOG, University of Oxford

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

December 1, 2005

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

January 3, 2010

First Submitted That Met QC Criteria

January 8, 2010

First Posted (Estimate)

January 11, 2010

Study Record Updates

Last Update Posted (Estimate)

January 11, 2010

Last Update Submitted That Met QC Criteria

January 8, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05/Q1605/87

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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