PCOSMIC Trial - PolyCystic Ovary Syndrome, Metformin for Infertility With Clomiphene

Polycystic Ovary Syndrome Clinical Trial

— PCOSMIC  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00795808
• Other study ID #: UAuckland
• Status: Completed
• Phase: Phase 4
• First received: November 20, 2008
• Last updated: November 20, 2008
• Start date: August 2003
• Est. completion date: October 2008

Study information

• Verified date: November 2008
• Source: University of Auckland, New Zealand
• Contact: n/a
• Is FDA regulated: No
• Health authority: New Zealand: Health Research Council
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 171
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 39 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility
• Polycystic Ovary Syndrome
• Syndrome

Intervention

Drug:
• 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

Locations

Country	Name	City	State
New Zealand	University of Auckland	Auckland

Sponsors (3)

Lead Sponsor	Collaborator
University of Auckland, New Zealand	Auckland Medical Research Foundation, Mercia Barnes Trust of the Royal Australian and New Zealand College of Obstetricians and Gynaecologists

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical pregnancy		within 6 calendar months of randomisation	No
Secondary	Live birth			No
Secondary	Adverse events			Yes