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

Phase 4 Completed 171 enrolled University of Auckland, New Zealand Auckland Medical Research Foundation · collab Mercia Barnes Trust of the Royal Australian and New Zealand College of Obstetricians and Gynaecologists · collab

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start: 2003-08
Primary completion: 2008-10
Completion: 2008-10

Outcome

Missed primary endpoint

paper There is no evidence that adding metformin to 'standard care' is beneficial. PMID 20435692 ↗

paper there is no evidence of significant differences in outcomes whether treated with metformin, CC or both. PMID 20435692 ↗

Publications

Johnson NP, Stewart AW, Falkiner J, Farquhar CM, Milsom S, Singh VP, Okonkwo QL, Buckingham KL; REACT-NZ (REproduction And Collaborative Trials in New Zealand), a multi-centre fertility trials group. PCOSMIC: a multi-centre randomized trial in women with PolyCystic Ovary Syndrome evaluating Metformin for Infertility with Clomiphene. Hum Reprod. 2010 Jul;25(7):1675-83. doi: 10.1093/humrep/deq100. Epub 2010 Apr 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Clomiphene Citrate	Other / unclassified	—	—
Subject	Metformin	Small molecule	500 mg	—