Welcome
Support Centre
25 July 2014 
ISRCTN Register - International Standard Randomized Controlled Trial Number
Trial registration
Unique identification scheme
International databases
home  |   my details  |   ISRCTN Register  |   mRCT  |   links  |   information  |   news
Find trials
ISRCTN Register
tips on searching

Registration
New application
Updating record

Information
introduction
governing board
ISRCTN FAQs
data set
letter of agreement
request information
guidance notes
statistics

[ Print-friendly version ]
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 10.1186/ISRCTN55906981
ClinicalTrials.gov identifier
EudraCT number
Public title 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
Scientific title
Acronym The Metformin trial
Serial number at source NTR485
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.
Lay summary Not provided at time of registration
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment Netherlands
Disease/condition/study domain Polycystic Ovary Syndrome (PCOS)
Participants - inclusion criteria All patients with chronic anovulation World Health Organization (WHO) type II, polycystic ovaries diagnosed by transvaginal ultrasonography and child wish.
Participants - 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)
Anticipated start date 01/06/2001
Anticipated end date 01/06/2004
Status of trial Completed
Patient information material
Target number of participants 228
Interventions 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.
Primary outcome measure(s) Ovulation.
Secondary outcome measure(s) 1. Ongoing pregnancy
2. Spontaneous abortion
3. Clomiphene citrate resistance
Sources of funding Merck B.V. (The Netherlands)
Trial website
Publications 1. 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16769748
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22926838
Contact name Dr  Etelka  Moll
  Address Academic Medical Center
Department of Obstetrics & Gynecology
P.O. Box 22660
  City/town Amsterdam
  Zip/Postcode 1100 DD
  Country Netherlands
  Email E.Moll@amc.uva.nl
Sponsor Academic Medical Center (AMC) (The Netherlands)
  Address Department of Obstetrics and Gynaecology
Meibergdreef 9
  City/town Amsterdam
  Zip/Postcode 1105 AZ
  Country Netherlands
  Sponsor website: http://www.amc.uva.nl/
Date applied 27/01/2006
Last edited 04/04/2013
Date ISRCTN assigned 27/01/2006
Submit your trial protocol
Submit to Trials journal
Follow us on Twitter
© 2014 ISRCTN unless otherwise stated.