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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.


- candidate number1694
- NTR NumberNTR485
- ISRCTNISRCTN55906981
- Date ISRCTN created27-jan-2006
- date ISRCTN requested18-nov-2005
- Date Registered NTR15-sep-2005
- Secondary IDsN/A 
- Public TitleOvulation 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 TitleOvulation 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.
- ACRONYMThe Metformin trial
- hypothesisTo 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 sponteneous abortions.
- Healt Condition(s) or Problem(s) studiedPolycystic ovary syndrome (PCOS)
- Inclusion criteriaAll patients with chronic anovulation WHO type II, polycystic ovaries diagnosed by transvaginal ultrasonography and child wish.
- Exclusion criteriaPrimary exclusion criteria:
1. other causes of anovulation;
2. age over 40 years;
3. liver-, kidney or heart disease/failure (i.e. abnormal results on liver function tests, serum creatinine concentration > 95 umol/l or a history of heart disease/failure) and sperm quality indicating male factor subfertility (Total Motile Count < 10 x 106).
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jun-2001
- planned closingdate1-jun-2004
- Target number of participants228
- InterventionsMetformin 4dd 500mg plus clomiphene citrate 50-150mg;
Controls: Placebo 4dd plus clomiphene citrate 50-150mg;
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 outcomeOvulation.
- Secondary outcome1. Ongoing pregnancy;
2. Sponteneous abortion;
3. Clomiphene citrate resistance.
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESDrs. Etelka Moll
- CONTACT for SCIENTIFIC QUERIESDrs. Etelka Moll
- Sponsor/Initiator Academic Medical Center (AMC), Department of Obstetrics and Gynaecology
- Funding
(Source(s) of Monetary or Material Support)
Merck
- PublicationsBMJ. 2006 Jun 24;332(7556):1485. Epub 2006 Jun 12.
- Brief summaryN/A
- Main changes (audit trail)
- RECORD15-sep-2005 - 12-jun-2008


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