Clinical trial · Interventional
Treatment of Infertility in Women With Polycystic Ovary Syndrome
Pregnancy in Polycystic Ovary Syndrome: A 30 Week Double-Blind Randomized Trial of Clomiphene Citrate, Metformin XR, and Combined Clomiphene Citrate/Metformin XR For the Treatment of Infertility in Women With Polycystic Ovary Syndrome
NCT00068861CI-TRIAL-00000898completedPhase 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)
Polycystic Ovary Syndrome (PCOS) is a common endocrine disorder affecting up to 10% of women. The primary symptoms of PCOS are menstrual irregularities, increased body and facial hair, acne, and infertility. This study will test a combination of medications in women with PCOS to determine which works best to overcome infertility.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Infertility | — | UNRESOLVED | — |
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
| Pregnancy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| clomiphene citrate | Drug | — | UNRESOLVED |
| metformin XR | Drug | Metformin | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Live birth rate
Secondary outcomes (7)
- measure
- singleton live birth rate
- measure
- ovulation rate
- measure
- cycles to first ovulation
- measure
- cycles to conception
- measure
- abortion rate
- measure
- cycles to pregnancy
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 39 Years
Show eligibility criteria text
Inclusion Criteria * Eight or fewer menstrual cycles in the past year or intermenstrual periods of 45 days or longer * Elevated testosterone level * Good general health * Sperm concentration in partner of 20 million/ml or greater * Ability to have intercourse 2-3 times per week * One functional fallopian tube and normal uterine cavity
References
Publications (13)
- BACKGROUNDMyers ER, Silva SG, Hafley G, Kunselman AR, Nestler JE, Legro RS; National Institute of Child Health and Human Development Reproductive Medicine Network. Estimating live birth rates after ovulation induction in polycystic ovary syndrome: sample size calculations for the pregnancy in polycystic ovary syndrome trial. Contemp Clin Trials. 2005 Jun;26(3):271-80. doi: 10.1016/j.cct.2005.01.006. PMID 15911461
- DERIVEDChan JL, Legro RS, Eisenberg E, Pisarska MD, Santoro N. Correlation of Polycystic Ovarian Syndrome Phenotypes With Pregnancy and Neonatal Outcomes. Obstet Gynecol. 2024 Oct 1;144(4):543-549. doi: 10.1097/AOG.0000000000005702. Epub 2024 Aug 22. PMID 39173182
- DERIVEDKomorowski AS, Hughes L, Sarkar P, Aaby DA, Kumar A, Kalra B, Legro RS, Boots CE. Antimullerian hormone level predicts ovulation in women with polycystic ovary syndrome treated with clomiphene and metformin. Fertil Steril. 2024 Apr;121(4):660-668. doi: 10.1016/j.fertnstert.2023.12.031. Epub 2023 Dec 26. PMID 38154770
- DERIVEDKuang H, Jin S, Thomas T, Engmann L, Hansen KR, Coutifaris C, Casson P, Christman G, Alvero R, Santoro N, Eisenberg E, Diamond MP, Legro RS, Zhang H; Reproductive Medicine Network. Predictors of participant retention in infertility treatment trials. Fertil Steril. 2015 Nov;104(5):1236-43.e1-2. doi: 10.1016/j.fertnstert.2015.08.001. Epub 2015 Sep 3. PMID 26354094
- DERIVEDLegro RS. Pregnancy in polycystic ovary syndrome I: lessons from a pragmatic explanatory with repository clinical trial. Semin Reprod Med. 2015 May;33(3):213-9. doi: 10.1055/s-0035-1552920. Epub 2015 Jun 2. PMID 26036903
- DERIVEDLegro RS, Chen G, Kunselman AR, Schlaff WD, Diamond MP, Coutifaris C, Carson SA, Steinkampf MP, Carr BR, McGovern PG, Cataldo NA, Gosman GG, Nestler JE, Myers ER, Zhang H, Foulds J; Reproductive Medicine Network. Smoking in infertile women with polycystic ovary syndrome: baseline validation of self-report and effects on phenotype. Hum Reprod. 2014 Dec;29(12):2680-6. doi: 10.1093/humrep/deu239. Epub 2014 Oct 16.