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

Phase 4

Completed

• Conditions: Polycystic Ovary Syndrome
• Interventions: Drug: Metformin; Drug: Metformin + Clomiphene; Drug: Placebo; Drug: Clomiphene

• Registration Number: NCT00795808
• Lead Sponsor: University of Auckland, New Zealand

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 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

Not available

Study Timeline

• Study Start: 2003-08
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Status Verified: 2008-11
• Study First Submitted: 2008-11-20
• Study First Submitted QC: 2008-11-20
• Last Update Submitted: 2008-11-20
• Study First Posted: 2008-11-21
• Last Update Posted: 2008-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 171

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BMI > 32	Metformin	Women with BMI \> 32
BMI > 32	Placebo	Women with BMI \> 32
BMI </= 32	Metformin + Clomiphene	Women with BMI \</= 32
BMI </= 32	Metformin	Women with BMI \</= 32
BMI </= 32	Clomiphene	Women with BMI \</= 32

Primary Outcome Measures

Name	Time	Method
Clinical pregnancy	within 6 calendar months of randomisation

Secondary Outcome Measures

Name	Time	Method
Live birth
Adverse events

Trial Locations

Locations (1)

University of Auckland; 🇳🇿 Auckland, New Zealand