Therapy for Infertile PCOS Patients Ovulating Under Clomiphene Citrate or Metformin
Overview[ - collapse ][ - ]
| Purpose | Several data demonstrated that both clomiphene citrate (CC) and metformin are two safe and valid first-step options to induce ovulation in infertile anovulatory PCOS patients. Notwithstanding a high percentage of patients ovulate under treatment, only ~40% and 60% of subjects obtain a pregnancy after CC and metformin, respectively. For these patients, controlled ovarian stimulation (COS) followed by intrauterine insemination (IUI) could be the next therapeutic step before assisted reproductive techniques since IUI improves significantly the fertility in couples with unexplained infertility. Furthermore, to date it is not defined if COS should be obtained using the same ovulatory agent (CC or metformin) or switching the treatment to gonadotropins. In this view, the aim of the present study will be to evaluate the best management of infertile PCOS patients ovulating after CC or metformin. |
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| Condition | Polycystic Ovary Syndrome Infertility |
| Intervention | Drug: Clomiphene citrate, metformin, highly purified urinary FSH |
| Phase | Phase 4 |
| Sponsor | University Magna Graecia |
| Responsible Party | University Magna Graecia |
| ClinicalTrials.gov Identifier | NCT00502229 |
| First Received | July 12, 2007 |
| Last Updated | April 5, 2013 |
| Last verified | April 2013 |
Tracking Information[ + expand ][ + ]
| First Received Date | July 12, 2007 |
|---|---|
| Last Updated Date | April 5, 2013 |
| Start Date | January 2010 |
| Estimated Primary Completion Date | Not Provided |
| Current Primary Outcome Measures | Pregnancy rate [Time Frame: one year] |
| Current Secondary Outcome Measures | Ovulation rate Abortion rate Live-birth rate Adverse events [Time Frame: one year] |
Descriptive Information[ + expand ][ + ]
| Brief Title | Therapy for Infertile PCOS Patients Ovulating Under Clomiphene Citrate or Metformin |
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| Official Title | What is the Following Step to Improve Fertility in Infertile PCOS Patients Ovulating Under Clomiphene Citrate or Metformin? A Randomized Controlled Clinical Study. |
| Brief Summary | Several data demonstrated that both clomiphene citrate (CC) and metformin are two safe and valid first-step options to induce ovulation in infertile anovulatory PCOS patients. Notwithstanding a high percentage of patients ovulate under treatment, only ~40% and 60% of subjects obtain a pregnancy after CC and metformin, respectively. For these patients, controlled ovarian stimulation (COS) followed by intrauterine insemination (IUI) could be the next therapeutic step before assisted reproductive techniques since IUI improves significantly the fertility in couples with unexplained infertility. Furthermore, to date it is not defined if COS should be obtained using the same ovulatory agent (CC or metformin) or switching the treatment to gonadotropins. In this view, the aim of the present study will be to evaluate the best management of infertile PCOS patients ovulating after CC or metformin. |
| Detailed Description | Infertile PCOS patients who ovulated under CC or metformin without pregnancy achievement will be enrolled and treated with three trials of COS plus IUI. All patients will be randomly allocated into two different groups (groups A and B). In group A, COS will be obtained using the same ovulatory agent (CC or metformin) employed in the previous ovulatory cycles, whereas in group B using gonadotropins in a low-dose step-up regimen. 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 and the will be analyzed also categorizing the patients according to ovulatory agent used for COS (CC or metformin). 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. |
| Study Type | Interventional |
| Study Phase | Phase 4 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition |
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| Intervention | Drug: Clomiphene citrate, metformin, highly purified urinary FSH |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Withdrawn |
|---|---|
| Estimated Enrollment | Not Provided |
| Estimated Completion Date | Not Provided |
| Estimated Primary Completion Date | January 2011 |
| Eligibility Criteria | Inclusion Criteria: - Polycystic ovary syndrome (using NIH criteria) - Anovulatory infertility (using WHO criteria) 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 drugs - 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 |
| Gender | Female |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Italy |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00502229 |
|---|---|
| Other Study ID Numbers | 05/2006c |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | University Magna Graecia |
| Study Sponsor | University Magna Graecia |
| Collaborators | Not Provided |
| Investigators | Principal Investigator: Stefano Palomba, MD Department of Obstetrics & Gynecology, University "Magna Graecia" of CatanzaroPrincipal Investigator: Francesco Orio, MD Department of Endocrinology, University "Federico II" of NaplesPrincipal Investigator: Achille Tolino, MD Department of Obstetrics & Gynecology, University "Federico II" of Naples |
| Verification Date | April 2013 |
Locations[ + expand ][ + ]
| Pugliese Hospital | Catanzaro, Catanzaro, CZ, Italy, 88100 |
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