PCOSMIC Trial - PolyCystic Ovary Syndrome, Metformin for Infertility With Clomiphene
NCT ID: NCT00795808
Last Updated: 2008-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
171 participants
INTERVENTIONAL
2003-08-31
2008-10-31
Brief Summary
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2. Metformin in combination with clomiphene, is more effective than clomiphene alone or metformin alone improves fertility outcomes in women with PCOS of reasonably healthy body weight (BMI \</= 32).
3. Metformin improves fertility outcomes in women with BMI \> 32 with PCOS.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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BMI > 32
Women with BMI \> 32
Metformin
500mg tds for 6 months
Placebo
One tablet tds for 6 months
BMI </= 32
Women with BMI \</= 32
Metformin + Clomiphene
500mg tds + Ovulatory dose for 6 months
Metformin
500mg tds for 6 months
Clomiphene
Ovulatory dose for 6 months
Interventions
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Metformin
500mg tds for 6 months
Placebo
One tablet tds for 6 months
Metformin + Clomiphene
500mg tds + Ovulatory dose for 6 months
Metformin
500mg tds for 6 months
Clomiphene
Ovulatory dose for 6 months
Eligibility Criteria
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Inclusion Criteria
* Anovulatory infertility of duration at least 12 months.
* Polycystic ovary syndrome, based on Rotterdam consensus criteria.
* Normal serum prolactin, thyroid function and 17-hydroxyprogesterone.
* Normal serum prolactin, thyroid function and 17-hydroxyprogesterone;
Exclusion Criteria
* Already taking oral hypoglycaemics.
* Diabetics receiving treatment.
* Renal impairment
* Chronic hepatic disease
* Cardiac Disease
* Alcohol dependency
* Pre-disposition to lactic acidosis
* Previous ovarian drilling procedure, gonadotrophin injection therapy, IUI (intrauterine insemination) or IVF ( in vitro fertilisation).
* For those women who have had previous fertility treatment, the following would be excluded:
* Women who have had \> 5 cycles of clomiphene citrate
* Women who have had \> 5 months metformin treatment previously
* Women who have proven to be resistant to 100mg or more of clomiphene citrate.
18 Years
39 Years
FEMALE
Yes
Sponsors
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Auckland Medical Research Foundation
OTHER
Mercia Barnes Trust of the Royal Australian and New Zealand College of Obstetricians and Gynaecologists
OTHER
University of Auckland, New Zealand
OTHER
Responsible Party
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University of Auckland, Fertility Plus and Repromed Auckland
Principal Investigators
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Neil P Johnson, FRANZCOG
Role: PRINCIPAL_INVESTIGATOR
University of Auckland, fertility Plus & Repromed Auckland
Locations
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University of Auckland
Auckland, , New Zealand
Countries
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References
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Johnson NP, Stewart AW, Falkiner J, Farquhar CM, Milsom S, Singh VP, Okonkwo QL, Buckingham KL; REACT-NZ (REproduction And Collaborative Trials in New Zealand), a multi-centre fertility trials group. PCOSMIC: a multi-centre randomized trial in women with PolyCystic Ovary Syndrome evaluating Metformin for Infertility with Clomiphene. Hum Reprod. 2010 Jul;25(7):1675-83. doi: 10.1093/humrep/deq100. Epub 2010 Apr 30.
Other Identifiers
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UAuckland
Identifier Type: -
Identifier Source: org_study_id