Therapy for Infertile PCOS Patients Ovulating Under Clomiphene Citrate or Metformin
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00502229 |
Recruitment Status
:
Withdrawn
First Posted
: July 17, 2007
Last Update Posted
: April 9, 2013
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Polycystic Ovary Syndrome Infertility | Drug: Clomiphene citrate, metformin, highly purified urinary FSH | Phase 4 |
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 (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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. |
Study Start Date : | January 2010 |
Actual Primary Completion Date : | January 2011 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Group A
Continuing treatment
|
Drug: Clomiphene citrate, metformin, highly purified urinary FSH |
Active Comparator: Group B
Gonadotrophins
|
Drug: Clomiphene citrate, metformin, highly purified urinary FSH |
- Pregnancy rate [ Time Frame: one year ]
- Ovulation rate Abortion rate Live-birth rate Adverse events [ Time Frame: one year ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 35 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00502229
Italy | |
Pugliese Hospital | |
Catanzaro, Catanzaro, CZ, 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 |
Publications:
Responsible Party: | Stefano Palomba, Associate Professor, University Magna Graecia |
ClinicalTrials.gov Identifier: | NCT00502229 History of Changes |
Other Study ID Numbers: |
05/2006c |
First Posted: | July 17, 2007 Key Record Dates |
Last Update Posted: | April 9, 2013 |
Last Verified: | April 2013 |
Keywords provided by Stefano Palomba, University Magna Graecia:
Clomiphene citrate Controlled overian stimulation Infertility |
Metformin Polycystic ovary syndrome 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 Metformin Citric Acid Clomiphene Enclomiphene |
Zuclomiphene Hypoglycemic Agents Physiological Effects of Drugs Anticoagulants Calcium Chelating Agents Chelating Agents Sequestering Agents Molecular Mechanisms of Pharmacological Action Estrogen Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Fertility Agents, Female Fertility Agents Reproductive Control Agents Selective Estrogen Receptor Modulators |