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| Name | Class |
|---|---|
| Auckland Medical Research Foundation | OTHER |
| Mercia Barnes Trust of the Royal Australian and New Zealand College of Obstetricians and Gynaecologists | OTHER |
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMI > 32 | Experimental | Women with BMI > 32 |
|
| BMI </= 32 | Experimental | Women with BMI \ |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | 500mg tds for 6 months |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical pregnancy | within 6 calendar months of randomisation |
| Measure | Description | Time Frame |
|---|---|---|
| Live birth | ||
| Adverse events |
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Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Neil P Johnson, FRANZCOG | University of Auckland, fertility Plus & Repromed Auckland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Auckland | Auckland | New Zealand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20435692 | Derived | 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. |
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| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| D000858 | Anovulation |
| D007246 | Infertility |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| D002996 | Clomiphene |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D013267 |
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| Drug |
One tablet tds for 6 months |
|
| Metformin + Clomiphene | Drug | 500mg tds + Ovulatory dose for 6 months |
|
| Metformin | Drug | 500mg tds for 6 months |
|
| Clomiphene | Drug | Ovulatory dose for 6 months |
|
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |