Treatment of Anovulatory Infertility in PCOS Patients

Sponsor

University Magna Graecia (Other)

Overall Status

Completed

CT.gov ID

NCT00471523

Collaborator

(none)

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Clomiphene citrate (CC) and metformin are two effective drugs used to induce ovulation in patients with polycystic ovary syndrome (PCOS), even if it is still unclear which compound between them should be initially administered. The aim of the study will be to compare in a clinical setting the efficacy of CC and metformin as first-line approaches for treating anovulation in infertile PCOS patients.

Condition or Disease	Intervention/Treatment	Phase
Infertility Polycystic Ovary Syndrome Anovulation	Drug: Clomiphene citrate Drug: Metformin	Phase 4

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

80 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2006

Actual Study Completion Date :

Mar 1, 2007

Outcome Measures

Primary Outcome Measures

Pregnancy rate [10 months]

Secondary Outcome Measures

Ovulation rate [6 months]
Abortion rate [10 months]
Time to first pregnancy [10 months]
Adverse events [10 months]
N. pregnancies/n. ovulatory cycles [10 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 41 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	"Pugliese Hospital"	Catanzaro	CZ	Italy	88100

Sponsors and Collaborators

University Magna Graecia

Investigators

Principal Investigator: Stefano Palomba, MD, Department of Obstetrics & Gynecology, University "Magna Graecia" of Catanzaro
Principal Investigator: Achille Tolino, MD, Department of Obstetrics & Gynecology, University "Federico II" of Naples
Principal Investigator: Francesco Orio, MD, Department of Endocrinology, University "Federico II" of Naples