Status:
COMPLETED
PCOSMIC Trial - PolyCystic Ovary Syndrome, Metformin for Infertility With Clomiphene
Lead Sponsor:
University of Auckland, New Zealand
Collaborating Sponsors:
Auckland Medical Research Foundation
Mercia Barnes Trust of the Royal Australian and New Zealand College of Obstetricians and Gynaecologists
Conditions:
Polycystic Ovary Syndrome
Eligibility:
FEMALE
18-39 years
Phase:
PHASE4
Brief Summary
1. Metformin increases the pregnancy rate when added to the standard treatment of anovulatory polycystic ovary syndrome (PCOS). 2. Metformin in combination with clomiphene, is more effective than clom...
Eligibility Criteria
Inclusion
- Women between the age of 18 and 39 years inclusive.
- 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
- Presence of any other significant infertility factor including male factor, known tubal disease or history of an ectopic pregnancy, known endometriosis affecting the fallopian tubes or ovaries.
- 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.
Key Trial Info
Start Date :
August 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
171 Patients enrolled
Trial Details
Trial ID
NCT00795808
Start Date
August 1 2003
End Date
October 1 2008
Last Update
November 21 2008
Active Locations (1)
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1
University of Auckland
Auckland, New Zealand