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

Study Overview
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Brief Summary
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Metformin increases the pregnancy rate when added to the standard treatment of anovulatory polycystic ovary syndrome (PCOS). 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). Metformin improves fertility outcomes in women with BMI > 32 with PCOS.

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

Conditions
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Polycystic Ovary Syndrome

Intervention / Treatment
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* Drug: Metformin
* Drug: Placebo
* Drug: Metformin + Clomiphene
* Drug: Metformin
* Drug: Clomiphene


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BMI > 32<br>Women with BMI > 32 | Drug: Metformin<br>* 500mg tds for 6 months<br>Drug: Placebo<br>* One tablet tds for 6 months<br>|
| Experimental: BMI </= 32<br>Women with BMI </= 32 | Drug: Metformin + Clomiphene<br>* 500mg tds + Ovulatory dose for 6 months<br>Drug: Metformin<br>* 500mg tds for 6 months<br>Drug: Clomiphene<br>* Ovulatory dose for 6 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy |  | within 6 calendar months of randomisation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Live birth |  |  | 
| Adverse events |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Polycystic ovary syndrome, PCOS, Anovulation, Infertility, Anovulatory polycystic ovary syndrome (PCOS)