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- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00501904
Metformin in Infertile PCOS Patients
Efficacy of Long- Versus Short-term Metformin Protocol in Infertile Anovulatory PCOS Patients
Metformin, an oral biguanide administrated for treating type-2 diabetes mellitus, is a safe and effective drug recently experimented also in patients with polycystic ovary syndrome (PCOS). The administration of metformin induces ovulatory cycles in CC-resistant or -nonresistant patients with PCOS, and improves the ovulation rate as an additional treatment in women who received CC.
To date, it is unknown the best protocol for metformin administration. In particular, it is not known how long patients who ovulate under metformin should continue treatment before switching to second-line ovulation induction therapy. In this regard, in a recent study by the Kaplan-Meier survival analysis we demonstrated that the first pregnancy occurred late after metformin with an estimated median of seven months.
Based on these considerations, the aim of the present study will be to evaluate the clinical efficacy of metformin according to its duration of administration in infertile PCOS patients ovulating under treatment.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Infertile PCOS patients having three ovulatory cycles under metformin, administered using tailored protocol, will be enrolled and randomized in two groups (groups A and B). Patients of group A will continue metformin administration for further three cycles followed by six months of progestogens cyclically administered, whereas patients of group B will continue metformin therapy for further nine cycles.
All patients eligible will undergo baseline assessment consisting of anthropometric, hormonal, and ultrasonographic evaluations. During the study, the clinical and reproductive outcomes, and the adverse experience will be evaluated in each patient.
Data will be analyzed using the intention-to-treat principle and a P value of 0.05 or less will be considered significant. Continuous variables will be analyzed with the unpaired t test and general linear model for repeated measures analysis with Bonferroni test for the post-hoc analysis as required. For categorical variables, the Pearson chi-square and Fisher's exact tests will be used. Cumulative pregnancy rate, our primary end-point, will be calculated by the Kaplan-Maier method, and the differences between the two groups will be assessed with the log-rank test. Cox proportional-hazards model will be used to calculate the hazard ratio for new pregnancy in both groups.
Tipo di studio
Iscrizione (Anticipato)
Fase
- Fase 4
Contatti e Sedi
Contatto studio
- Nome: Stefano Palomba, MD
- Numero di telefono: +39-0961-883234
- Email: stefanopalomba@tin.it
Luoghi di studio
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Catanzaro, CZ, Italy
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Catanzaro, Catanzaro, CZ, Italy, Italia, 88100
- Reclutamento
- Pugliese Hospital
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Contatto:
- Ingrid Tomaino, MD
- Numero di telefono: +39-0961965097
- Email: angela.falbo@libero.it
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Polycystic ovary syndrome (using NIH criteria)
- Anovulatory infertility (using WHO criteria)
- Ovulatory cycles under metformin (three cycles)
Exclusion Criteria:
- Age <18 or >35 years
- Severe obesity (BMI >35)
- 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, antidiabetic and anti-obesity drugs or other hormonal drugsPrevious use of ovulation induction agents
- Intention to start a diet or a specific program of physical activity
- Organic pelvic diseases
- Previous pelvic surgery
- Suspected peritoneal factor infertility
- Tubal or male factor infertility or sub-fertility
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Comparatore attivo: Group A
Short protocol
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Comparatore attivo: Group B
Long protocol
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
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Tasso di gravidanza
Lasso di tempo: 12 mesi
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12 mesi
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
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Ovulation rate Abortion rate Live-birth rate Adverse events
Lasso di tempo: 21 months
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21 months
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Stefano Palomba, MD, Department of Obstetrics & Gynecology, University "Magna Graecia" of Catanzaro
- Investigatore principale: Francesco Orio, MD, Department of Endocrinology, University "Federico II" of Naples
- Investigatore principale: Achille Tolino, MD, Department of Obstetrics & Gynecology, University "Federico II" of Naples
Pubblicazioni e link utili
Pubblicazioni generali
- Palomba S, Orio F Jr, Falbo A, Russo T, Tolino A, Zullo F. Clomiphene citrate versus metformin as first-line approach for the treatment of anovulation in infertile patients with polycystic ovary syndrome. J Clin Endocrinol Metab. 2007 Sep;92(9):3498-503. doi: 10.1210/jc.2007-1009. Epub 2007 Jun 26.
- Palomba 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.
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 05/2006b
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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