Clomiphene Citrate in Infertile PCOS Patients
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Purpose
Anovulatory infertility is a common feature of the polycystic ovary syndrome (PCOS). Clomiphene citrate (CC) represents the first therapeutic option for treating the anovulatory infertility in PCOS patients because it is characterized by low costs, limited dose-dependent side effects, and simplicity of administration and management due to no need for ongoing monitoring.
Excellent results in terms of ovulations have been obtained using CC. However, only 50% of patients who ovulates under CC will conceive. The exact explanation for the discrepancy between the ovulation and pregnancy rates is unknown, but several hypotheses on the anti-estrogenic effects that CC exerts on the ovary and uterus have been suggested.
To date, few data are available on the optimal schedule for CC administration, and it is unknown how long patients who ovulate under CC should continue treatment before switching to second-line ovulation induction therapy. The aim of the study was to define the clinical benefits of CC administration according to its duration of administration.
| Condition | Intervention | Phase |
|---|---|---|
|
Polycystic Ovary Syndrome Infertility |
Drug: clomiphene citrate |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | How Long Should First-line Treatment be Continued in Infertile PCOS Patients Who Ovulate Under Clomiphene Citrate? A Randomized Controlled Clinical Study. |
- Cumulative pregnancy rate [ Time Frame: 12 months ]
- Ovulation rate Abortion rate Live-birth rate Adverse events Multiple pregnancy rate [ Time Frame: 21 months ]
| Enrollment: | 0 |
| Study Start Date: | August 2008 |
| Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Group A
Cyclic progestogens for nine months
|
Drug: clomiphene citrate |
|
Active Comparator: Group B
CC treatment for further three cycles at the same ovulating doses followed by six months of cyclic progestogens
|
Drug: clomiphene citrate |
|
Active Comparator: Group C
CC administration at the same ovulating doses for nine cycles
|
Drug: clomiphene citrate |
Detailed Description:
Infertile PCOS patients who had three previous ovulatory cycles under CC will be enrolled and randomized in three groups (groups A, B, and C). In group A, patients will receive cyclic progestogens for nine months; in group B, patients will continue CC treatment for further three cycles at the same ovulating doses followed by six months of cyclic progestogens; and in group C, patients will continue CC administration at the same ovulating doses for nine cycles. In each case, CC will be administered using a traditional incremental-doses protocol up to 150 mg daily.
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.
Eligibility| Ages Eligible for Study: | 18 Years to 35 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Polycystic ovary syndrome (using NIH criteria)
- Anovulatory infertility (using WHO criteria)
- Previous three CC-stimulated ovulatory 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 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
Contacts and Locations| Italy | |
| Pugliese Hospital | |
| Catanzaro, Catanzaro, CZ, Italy, Italy, 88100 | |
| Principal Investigator: | Stefano Palomba, MD | Department of Obstetrics & Gynecology, University "Magna Graecia" of Catanzaro |
| Principal Investigator: | Francesco Orio, MD | Department of Endocrinology, University "Federico II" of Naples |
| Principal Investigator: | Achille Tolino, MD | Department of Obstetrics & Gynecology, University "Federico II" of Naples |
More Information
Publications:
| Responsible Party: | Stefano Palomba, Associate Professor, University Magna Graecia |
| ClinicalTrials.gov Identifier: | NCT00501839 History of Changes |
| Other Study ID Numbers: | 05/2006a |
| Study First Received: | July 12, 2007 |
| Last Updated: | April 5, 2013 |
| Health Authority: | Italy: The Italian Medicines Agency |
Keywords provided by University Magna Graecia:
|
Anovulation Clomiphene citrate Infertility PCOS Treatment |
Additional relevant MeSH terms:
|
Infertility Polycystic Ovary Syndrome Genital Diseases, Male Genital Diseases, Female Ovarian Cysts Cysts Neoplasms Ovarian Diseases Adnexal Diseases Gonadal Disorders Endocrine System Diseases Citric Acid Clomiphene Anticoagulants |
Hematologic Agents Therapeutic Uses Pharmacologic Actions Chelating Agents Molecular Mechanisms of Pharmacological Action Estrogen Antagonists Estrogen Receptor Modulators Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Fertility Agents, Female Fertility Agents Reproductive Control Agents Selective Estrogen Receptor Modulators |
ClinicalTrials.gov processed this record on May 23, 2013