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Concerns about safety at the first interim analysis
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Metformin should be administered with caution and could be potentially dangerous in infertile patients with PCOS who show a poor ovarian response and are undergoing gonadotropin-based ovarian stimulation. However, data that address this point are totally lacking.
On the basis of these considerations, the aim of the current clinical trial was to test the hypothesis that metformin reduces the ovarian response in infertile patients with PCOS who have a potentially poor ovarian response and who undergo gonadotropin stimulation for IVF cycles.
Primary infertile patients with PCOS older than 35 years and/or with a basal follicle-stimulating hormone (FSH) level higher than 10 IU/L who were scheduled for IVF cycles were enrolled in the study protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metformin | Experimental | Metformin pre-treatment and co-administration |
|
| Placebo | Placebo Comparator | Placebo pre-treatment and co-administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | 500 mg three times daily |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of cancellation due to low ovarian response | Number of cancelled cycles/total cycles | one month |
| Measure | Description | Time Frame |
|---|---|---|
| Stimulation length | one month | |
| Gonadotropins dose | one month | |
| Ovulation rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fulvio Zullo, MD | Department of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro | Study Chair |
| Stefano Palomba, MD | Department of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pugliese" Hospital | Catanzaro | Italy | 88100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21917254 | Derived | Palomba S, Falbo A, Di Cello A, Cappiello F, Tolino A, Zullo F. Does metformin affect the ovarian response to gonadotropins for in vitro fertilization treatment in patients with polycystic ovary syndrome and reduced ovarian reserve? A randomized controlled trial. Fertil Steril. 2011 Nov;96(5):1128-33. doi: 10.1016/j.fertnstert.2011.08.020. Epub 2011 Sep 13. |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| Drug |
1 pill three times daily |
|
| one month |
| pregnancy rate | one month |
| Live-birth rate | nine months |
| Adverse effects | one month |