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Clomiphene Citrate Versus Metformin as First-Line Approach for the Treatment of Anovulation in Infertile Patients With Polycystic Ovary Syndrome


Phase 4
18 Years
41 Years
Not Enrolling
Female
Infertility, Polycystic Ovary Syndrome, Anovulation

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Trial Information

Clomiphene Citrate Versus Metformin as First-Line Approach for the Treatment of Anovulation in Infertile Patients With Polycystic Ovary Syndrome


Eighty infertile anovulatory patients with PCOS will be allocated in two body mass index
(BMI)- and age-matched groups (experimental and control groups).

Forty patients will receive the experimental treatment consisting of six months of 1700
mg/day metformin administration (experimental group), whereas other forty patients will
receive CC administered using a traditional incremental-doses protocol (control group). In
both groups, patients who will ovulate under treatment will continue the therapy for a total
of six months.

During the study, the clinical and reproductive outcomes, and the adverse experience will be
evaluated in each patient.


Inclusion Criteria:



- Anovulatory infertility related to polycystic ovary syndrome

Exclusion Criteria:

- 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, ovulation induction agents, antidiabetic and
anti-obesity drugs or other hormonal drugs.

- Organic pelvic diseases

- Previous pelvic surgery

- Suspected peritoneal factor infertility

- Tubal or male factor infertility or sub-fertility

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Pregnancy rate

Outcome Time Frame:

10 months

Principal Investigator

Stefano Palomba, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Obstetrics & Gynecology, University “Magna Graecia” of Catanzaro

Authority:

Italy: The Italian Medicines Agency

Study ID:

02-2006

NCT ID:

NCT00471523

Start Date:

May 2006

Completion Date:

March 2007

Related Keywords:

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

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