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”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: October 2008

Intervention(s) in this Clinical Trial

• Drug: Metformin
  • 500mg tds for 6 months
• Drug: Placebo
  • One tablet tds for 6 months
• Drug: Metformin + Clomiphene
  • 500mg tds + Ovulatory dose for 6 months
• Drug: Metformin
  • 500mg tds for 6 months
• Drug: Clomiphene
  • Ovulatory dose for 6 months

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: BMI > 32
  • Women with BMI > 32
• Experimental: BMI </= 32
  • Women with BMI </= 32

Primary Measures

• Clinical pregnancy
  • Time Frame: within 6 calendar months of randomisation
    Safety Issue?: No

Secondary Measures

• Live birth
  • Safety Issue?: No
• Adverse events
  • Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 39 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: University of Auckland, New Zealand

Overall Clinical Trial Officials and Contacts

Neil P Johnson, FRANZCOG Principal Investigator University of Auckland, fertility Plus & Repromed Auckland  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00795808

Study ID Number: UAuckland

ClinicalTrials.gov Identifier: NCT00795808

Health Authority: New Zealand: Health Research Council