PCOSMIC Trial - PolyCystic Ovary Syndrome, Metformin for Infertility With Clomiphene
Information source: University of Auckland, New Zealand
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Polycystic Ovary Syndrome
Intervention: Metformin (Drug); Placebo (Drug); Metformin + Clomiphene (Drug); Metformin (Drug); Clomiphene (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: University of Auckland, New Zealand Official(s) and/or principal investigator(s): Neil P Johnson, FRANZCOG, Principal Investigator, Affiliation: University of Auckland, fertility Plus & Repromed Auckland
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 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.
Clinical Details
Official title: Multi-Centre Randomised Controlled Trial of the Effectiveness of Metformin and Clomiphene Citrate for Treating Anovulatory Infertility in Women With Polycystic Ovary Syndrome
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Clinical pregnancy
Secondary outcome: Live birthAdverse events
Eligibility
Minimum age: 18 Years.
Maximum age: 39 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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.
Locations and Contacts
University of Auckland, Auckland, New Zealand
Additional Information
Starting date: August 2003
Last updated: November 20, 2008
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