Metformin in Assisted Reproduction-MET-AR-study

January 2, 2012 updated by: Norwegian University of Science and Technology

Metformin Treatment Before IVF / ICSI in Non-obese Women With Polycystic Ovarian Syndrome

Aim of study: To investigate whether four months of metformin treatment before IVF (in-vitro-fertilisation) or ICSI (intra-cytoplasmic-sperm-injection) might increase clinical pregnancy rate in normal-weight (body mass index [BMI] below 28 kg/m3) in PCOS (polycystic ovarian syndrome) women.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

PCOS is an hormonal disease including hyperandrogenism, oligo-or anovulation and/or polycystic ovaries by ultrasound. PCOS women often suffer insulin resistance or even diabetes risk as well as a full blown metabolic disease.

These women often suffer infertility due to their lack of regular ovulations. Metformin is a well known anti-diabetic drug, and in some PCOS women metformin might decrease the hyperandrogenism, improve insulin resistance and give more regular ovulations. Thereby increase chance of pregnancy. Our hypothesis is that metformin will increase clinical pregnancy rates both spontaneously and following IVF/ICSI.

Study Type

Interventional

Enrollment (Actual)

150

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

  • Norway
      • Trondheim, Norway, 7006
        • Sigrun Kjøtrød
      • Trondheim, Norway, 7046
        • Fertility UNit- -St Olavs Hospital

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 38 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Fulfilling Rotterdam criteria for PCOS
  • Infertility more than 1 year
  • First or second cycle of IVF/ICSI treatment
  • Age below 38 years at inclusion
  • BMI below 28 kg/m3 at inclusion
  • Willing to be randomised to 4 months metformin or placebo
  • Signed written informed consent

Exclusion Criteria:

  • Not suitable for starting dose 112.5 IE
  • Basal FSH above 10 IU/L
  • Known renal disease or s-creatinine above 110 umol/L
  • Known liver disease or s-ALAT above 80 IU/L
  • Known alcoholism or drug abuse
  • Known diabetes mellitus or fasting plasma glucose above 7 mmol/L
  • Corticosteroid treatment (oral)
  • Treatment with cimetidine, anticoagulants, erythromycin or other macrolides
  • Hyperprolactinemia (PRL above 700 mIU/L)
  • Abnormal thyroid function tests
  • Known congenital adrenal hyperplasia
  • Androgen secreting tumours
  • Cushing syndrome
  • Metformin treatment within the last one month prior to screening
  • Unfit to participate for any other reason

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: M: Metformin P: Placebo
Drug: Metformin / Placebo treatment for 4 months
M: Metformin 2000mg daily- 12-14 weeks of pretreatment + metformin 2000mg daily through conventional IVF ending on the day of pregnancy test; IE. 14 days after embryo transfer. P: Or identical placebo treatment for the same period

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To investigate whether four months of Metformin treatment before IVF (in-vitro-fertilisation) or ICSI (intra-cytoplasmic sperm injection) will increase clinical pregnancy rate in normal weight PCOS-women
Time Frame: Vaginal ultrasound in pregnancy week 7
Vaginal ultrasound in pregnancy week 7

Secondary Outcome Measures

Outcome Measure
Time Frame
Spontaneous pregnancy rates during the pretreatment period, Spontaneous abortion rates (I or II trim.abortions), Live birth rates,
Time Frame: Vaginal ultrasound in pregnancy week 7
Vaginal ultrasound in pregnancy week 7
Number of oocytes collected, Embryo quality, Number of days of gonadotrophin treatment, Dose of gonadotrophin, total per cycle and daily, s-estradiol on day of hCG-administration, Occurrence of ovarian hyperstimulation syndrome (OHSS)
Time Frame: All data evaluated at study end, from september 2009 onwards
All data evaluated at study end, from september 2009 onwards

Collaborators and Investigators

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

Sponsor

Norwegian University of Science and Technology

Investigators

  • Study Chair: Sven Carlsen, MD,PhD, St Olavs Hospital- Endocrinological section

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

March 1, 2005

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Estimate)

January 5, 2012

Last Update Submitted That Met QC Criteria

January 2, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MET-AR study -PCOS 5
  • EUDRACTNR. 2004-001124-20

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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