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
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
-
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.
-
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.