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How Long Should First-line Treatment be Continued in Infertile PCOS Patients Who Ovulate Under Clomiphene Citrate? A Randomized Controlled Clinical Study.

Phase 4
18 Years
35 Years
Not Enrolling
Polycystic Ovary Syndrome, Infertility

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Trial Information

How Long Should First-line Treatment be Continued in Infertile PCOS Patients Who Ovulate Under Clomiphene Citrate? A Randomized Controlled Clinical Study.

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.

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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Cumulative pregnancy rate

Outcome Time Frame:

12 months

Principal Investigator

Stefano Palomba, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Obstetrics & Gynecology, University "Magna Graecia" of Catanzaro


Italy: The Italian Medicines Agency

Study ID:




Start Date:

August 2008

Completion Date:

Related Keywords:

  • Polycystic Ovary Syndrome
  • Infertility
  • Anovulation
  • Clomiphene citrate
  • Infertility
  • PCOS
  • Treatment
  • Infertility
  • Polycystic Ovary Syndrome