Clinical trial · Interventional
The Effects of Metformin on Pregnancy and Miscarriage Rates in Polycystic Ovary Syndrome (PCOS)
Effects of Metformin on Fertility and Pregnancy in Women With Polycystic Ovary Syndrome: a Randomized, Prospective, Placebo-controlled Multicenter Study
NCT00994812CI-TRIAL-00003181completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is to determine whether metformin may improve pregnancy rates, and decrease miscarriage rates and complications of pregnancy, such as toxemia and gestational diabetes, in women with polycystic ovary syndrome (PCOS).
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gestational Diabetes | — | UNRESOLVED | — |
| Infertility | — | UNRESOLVED | — |
| Miscarriage | — | UNRESOLVED | — |
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
| Toxemia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| metformin | Drug | Metformin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Metformin
- interventionNames
- Drug: metformin
Primary outcomes (1)
- measure
- Miscarriage rates
- timeFrame
- at 7-8 weeks of pregnancy or later if miscarriage happens later
Secondary outcomes (3)
- measure
- Effect of metformin versus placebo on the time to be pregnant
- timeFrame
- 3-6 months
- measure
- Effect of metformin versus placebo on the rates of toxemia during pregnancy
- timeFrame
- 3 months after birth of the child
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: 1. age \< 40 years at entry 2. BMI \> 19 kg/m2 3. Infertility lasting \> 1 year 4. Criteria for PCOS are as defined by ESHRE/ASRM: at least two of the following findings: * polycystic ovaries shown by vaginal ultrasonography (more than 12 subcapsular follicles of 3-8 mm diameter in one plane of the ovary) * oligomenorrhea or amenorrhea * clinical manifestations of hyperandrogenism such as a hirsutism score of \> 7 according to Ferriman and Gallwey (Ferriman \& Gallwey 1961)and/or an elevated serum testosterone level (\> 2.7 nmol/l). Exclusion Criteria: 1. diabetic subjects 2. alcohol users 3. active liver disease (ALAT \> +2 SD the upper normal value i.e.\> 100IU/l) 4. hormonal drugs 5. past or present cardiac failure (NYHA I-IV) 6. liver or renal failure (S-Creatinine above the normal value ie.124 umol/l) 7. pregnancy or lactation 8. hypersensitivity to metformin
References
Publications (9)
- BACKGROUNDKashyap S, Wells GA, Rosenwaks Z. Insulin-sensitizing agents as primary therapy for patients with polycystic ovarian syndrome. Hum Reprod. 2004 Nov;19(11):2474-83. doi: 10.1093/humrep/deh440. Epub 2004 Sep 9. PMID 15358717
- BACKGROUNDGlueck CJ, Phillips H, Cameron D, Sieve-Smith L, Wang P. Continuing metformin throughout pregnancy in women with polycystic ovary syndrome appears to safely reduce first-trimester spontaneous abortion: a pilot study. Fertil Steril. 2001 Jan;75(1):46-52. doi: 10.1016/s0015-0282(00)01666-6. PMID 11163815
- BACKGROUNDGlueck CJ, Wang P, Kobayashi S, Phillips H, Sieve-Smith L. Metformin therapy throughout pregnancy reduces the development of gestational diabetes in women with polycystic ovary syndrome. Fertil Steril. 2002 Mar;77(3):520-5. doi: 10.1016/s0015-0282(01)03202-2. PMID 11872206
- BACKGROUNDJakubowicz DJ, Iuorno MJ, Jakubowicz S, Roberts KA, Nestler JE. Effects of metformin on early pregnancy loss in the polycystic ovary syndrome. J Clin Endocrinol Metab. 2002 Feb;87(2):524-9. doi: 10.1210/jcem.87.2.8207. PMID 11836280
- BACKGROUNDPalomba S, Orio F Jr, Falbo A, Manguso F, Russo T, Cascella T, Tolino A, Carmina E, Colao A, Zullo F. Prospective parallel randomized, double-blind, double-dummy controlled clinical trial comparing clomiphene citrate and metformin as the first-line treatment for ovulation induction in nonobese anovulatory women with polycystic ovary syndrome. J Clin Endocrinol Metab. 2005 Jul;90(7):4068-74. doi: 10.1210/jc.2005-0110. Epub 2005 Apr 19. PMID 15840746
- BACKGROUNDLegro RS, Barnhart HX, Schlaff WD, Carr BR, Diamond MP, Carson SA, Steinkampf MP, Coutifaris C, McGovern PG, Cataldo NA, Gosman GG, Nestler JE, Giudice LC, Leppert PC, Myers ER; Cooperative Multicenter Reproductive Medicine Network. Clomiphene, metformin, or both for infertility in the polycystic ovary syndrome. N Engl J Med. 2007 Feb 8;356(6):551-66. doi: 10.1056/NEJMoa063971.