Clinical trial · Interventional
Treatment of Anovulatory Infertility in PCOS Patients
Clomiphene Citrate Versus Metformin as First-Line Approach for the Treatment of Anovulation in Infertile Patients With Polycystic Ovary Syndrome
NCT00471523CI-TRIAL-00000726completedPhase 4ClinicalTrials.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)
Clomiphene citrate (CC) and metformin are two effective drugs used to induce ovulation in patients with polycystic ovary syndrome (PCOS), even if it is still unclear which compound between them should be initially administered. The aim of the study will be to compare in a clinical setting the efficacy of CC and metformin as first-line approaches for treating anovulation in infertile PCOS patients.
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 |
|---|---|---|---|
| Anovulation | — | UNRESOLVED | — |
| Infertility | — | UNRESOLVED | — |
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Clomiphene citrate | Drug | — | UNRESOLVED |
| Metformin | Drug | Metformin | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Pregnancy rate
- timeFrame
- 10 months
Secondary outcomes (5)
- measure
- Ovulation rate
- timeFrame
- 6 months
- measure
- Abortion rate
- timeFrame
- 10 months
- measure
- Time to first pregnancy
- timeFrame
- 10 months
- measure
- Adverse events
- timeFrame
- 10 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 41 Years
Show eligibility criteria text
Inclusion Criteria: * Anovulatory infertility related to polycystic ovary syndrome Exclusion Criteria: * Neoplastic, metabolic, hepatic, and cardiovascular disorders or other concurrent medical illnesses * Hypothyroidism, hyperprolactinemia, Cushing's syndrome, and non-classical congenital adrenal hyperplasia * Current or previous (within the last six months) use of oral contraceptives, glucocorticoids, antiandrogens, ovulation induction agents, antidiabetic and anti-obesity drugs or other hormonal drugs. * Organic pelvic diseases * Previous pelvic surgery * Suspected peritoneal factor infertility * Tubal or male factor infertility or sub-fertility
References
Publications (5)
- 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
- BACKGROUNDPalomba S, Orio F Jr, Falbo A, Russo T, Tolino A, Zullo F. Effects of metformin and clomiphene citrate on ovarian vascularity in patients with polycystic ovary syndrome. Fertil Steril. 2006 Dec;86(6):1694-701. doi: 10.1016/j.fertnstert.2006.05.035. Epub 2006 Oct 30. PMID 17074337
- BACKGROUNDPalomba S, Orio F, Zullo F. Ovulation induction in women with polycystic ovary syndrome. Fertil Steril. 2006 Jul;86 Suppl 1:S26-7. doi: 10.1016/j.fertnstert.2006.03.018. PMID 16798282
- BACKGROUNDPalomba S, Russo T, Orio F Jr, Falbo A, Manguso F, Sammartino A, Tolino A, Colao A, Carmina E, Zullo F. Uterine effects of clomiphene citrate in women with polycystic ovary syndrome: a prospective controlled study. Hum Reprod. 2006 Nov;21(11):2823-9. doi: 10.1093/humrep/del267. Epub 2006 Jul 10. PMID 16835214
- DERIVEDPalomba S, Falbo A, Orio F Jr, Tolino A, Zullo F. Efficacy predictors for metformin and clomiphene citrate treatment in anovulatory infertile patients with polycystic ovary syndrome. Fertil Steril. 2009 Jun;91(6):2557-67. doi: 10.1016/j.fertnstert.2008.03.011. Epub 2008 Apr 28. PMID 18440534