Condition category
Nutritional, Metabolic, Endocrine
Date applied
27/01/2006
Date assigned
27/01/2006
Last edited
04/04/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Etelka Moll

ORCID ID

Contact details

Academic Medical Center
Department of Obstetrics & Gynecology
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
E.Moll@amc.uva.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR485

Study information

Scientific title

Acronym

The Metformin trial

Study hypothesis

To compare the effectiveness of clomiphene citrate with metformin versus clomiphene citrate only in women with newly diagnosed polycystic ovary syndrome with respect to ovulation, pregnancy and spontaneous abortions.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Polycystic Ovary Syndrome (PCOS)

Intervention

1. Metformin 4 dd 500 mg plus clomiphene citrate 50 - 150 mg
2. Control: placebo 4 dd plus clomiphene citrate 50 - 150 mg

Patients used the medication as long as they were participating in the study. They stopped taking medication when they were clomiphene citrate resistant, pregnant or dropped out for a different reason.

Intervention type

Drug

Phase

Not Specified

Drug names

Clomiphene citrate, metformin

Primary outcome measures

Ovulation.

Secondary outcome measures

1. Ongoing pregnancy
2. Spontaneous abortion
3. Clomiphene citrate resistance

Overall trial start date

01/06/2001

Overall trial end date

01/06/2004

Reason abandoned

Eligibility

Participant inclusion criteria

All patients with chronic anovulation World Health Organization (WHO) type II, polycystic ovaries diagnosed by transvaginal ultrasonography and child wish.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

228

Participant exclusion criteria

1. Other causes of anovulation
2. Age over 40 years and liver, kidney or heart disease/failure (i.e. abnormal results on liver function tests
3. Serum creatinine concentration greater than 95 umol/l or a history of heart disease/failure)
4. Sperm quality indicating male factor subfertility (total motile count less than 10 x 10^6)

Recruitment start date

01/06/2001

Recruitment end date

01/06/2004

Locations

Countries of recruitment

Netherlands

Trial participating centre

Academic Medical Center
Amsterdam
1100 DD
Netherlands

Sponsor information

Organisation

Academic Medical Center (AMC) (The Netherlands)

Sponsor details

Department of Obstetrics and Gynaecology
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.amc.uva.nl/

Funders

Funder type

Industry

Funder name

Merck B.V. (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16769748
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22926838

Publication citations

  1. Results

    Moll E, Bossuyt PM, Korevaar JC, Lambalk CB, van der Veen F, Effect of clomifene citrate plus metformin and clomifene citrate plus placebo on induction of ovulation in women with newly diagnosed polycystic ovary syndrome: randomised double blind clinical trial., BMJ, 2006, 332, 7556, 1485, doi: 10.1136/bmj.38867.631551.55.

  2. Results

    Moll E, van Wely M, Lambalk CB, Bossuyt PM, van der Veen F, Health-related quality of life in women with newly diagnosed polycystic ovary syndrome randomized between clomifene citrate plus metformin or clomifene citrate plus placebo., Hum. Reprod., 2012, 27, 11, 3273-3278, doi: 10.1093/humrep/des310.

Additional files

Editorial Notes