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

Multi-Centre Randomised Controlled Trial of the Effectiveness of Metformin and Clomiphene Citrate for Treating Anovulatory Infertility in Women With Polycystic Ovary Syndrome

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00795808

Acronym

PCOSMIC

Enrollment

171

Registered

2008-11-21

Start date

2003-08-31

Completion date

2008-10-31

Last updated

2008-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic Ovary Syndrome

Keywords

Polycystic ovary syndrome, PCOS, Anovulation, Infertility, Anovulatory polycystic ovary syndrome (PCOS)

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.

Interventions

DRUGMetformin

500mg tds for 6 months

DRUGPlacebo

One tablet tds for 6 months

DRUGMetformin + Clomiphene

500mg tds + Ovulatory dose for 6 months

DRUGClomiphene

Ovulatory dose for 6 months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 39 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Clinical pregnancy	within 6 calendar months of randomisation

Secondary

Measure	Time frame
Live birth	—
Adverse events	—

Countries

New Zealand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 31, 2026