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

University of Auckland, New Zealand

Status and phase: Completed; Phase 4

Conditions: Polycystic Ovary Syndrome

Treatments: Drug: Metformin + Clomiphene; Drug: Placebo; Drug: Clomiphene; Drug: Metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT00795808

UAuckland

Details and patient eligibility

About

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.

Enrollment: 171 patients

Sex: Female

Ages: 18 to 39 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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171 participants in 2 patient groups

BMI > 32

Experimental group

Description:

Women with BMI \> 32

Treatment:

Drug: Metformin

Drug: Metformin

Drug: Placebo

BMI </= 32

Experimental group

Description:

Women with BMI \</= 32

Treatment:

Drug: Metformin

Drug: Metformin

Drug: Clomiphene

Drug: Metformin + Clomiphene