Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Clomiphene | Drug | — | UNRESOLVED |
| Metformin | Drug | Metformin | ALIAS |
| Metformin + Clomiphene | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- BMI > 32
- description
- Women with BMI \> 32
- interventionNames
- Drug: Metformin
- Drug: Placebo
- type
- EXPERIMENTAL
- label
- BMI </= 32
- description
- Women with BMI \</= 32
- interventionNames
- Drug: Metformin + Clomiphene
- Drug: Metformin
- Drug: Clomiphene
Primary outcomes (1)
- measure
- Clinical pregnancy
- timeFrame
- within 6 calendar months of randomisation
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 39 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDJohnson 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. PMID 20435692