Ovulation induction in women with newly diagnosed polycystic ovary syndrome: a randomised double blind clinical trial comparing clomiphene citrate plus metformin with clomiphene citrate plus placebo

ISRCTN ISRCTN55906981
DOI https://doi.org/10.1186/ISRCTN55906981
Secondary identifying numbers NTR485
Submission date
27/01/2006
Registration date
27/01/2006
Last edited
04/04/2013
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Etelka Moll
Scientific

Academic Medical Center
Department of Obstetrics & Gynecology
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

E.Moll@amc.uva.nl

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study acronymThe Metformin trial
Study objectivesTo 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedPolycystic Ovary Syndrome (PCOS)
Intervention1. 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Clomiphene citrate, metformin
Primary outcome measureOvulation.
Secondary outcome measures1. Ongoing pregnancy
2. Spontaneous abortion
3. Clomiphene citrate resistance
Overall study start date01/06/2001
Completion date01/06/2004

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants228
Key inclusion criteriaAll patients with chronic anovulation World Health Organization (WHO) type II, polycystic ovaries diagnosed by transvaginal ultrasonography and child wish.
Key exclusion criteria1. 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)
Date of first enrolment01/06/2001
Date of final enrolment01/06/2004

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Academic Medical Center
Amsterdam
1100 DD
Netherlands

Sponsor information

Academic Medical Center (AMC) (The Netherlands)
Hospital/treatment centre

Department of Obstetrics and Gynaecology
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

http://www.amc.uva.nl/
ROR logo https://ror.org/03t4gr691

Funders

Funder type

Industry

Merck B.V. (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 24/06/2006 Yes No
Results article results 01/11/2012 Yes No
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