Treatment of Anovulatory Infertility in PCOS Patients - Full Text View

Sponsor:	University Magna Graecia
Information provided by:	University Magna Graecia
ClinicalTrials.gov Identifier:	NCT00471523

Purpose

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	Intervention	Phase
Infertility Polycystic Ovary Syndrome Anovulation	Drug: Clomiphene citrate Drug: Metformin	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Infertility Polycystic Ovary Syndrome

Drug Information available for: Clomiphene citrate Zuclomiphene Enclomiphene Citric acid Metformin Clomiphene Sodium Citrate Metformin hydrochloride trans-Clomifene citrate

U.S. FDA Resources

Further study details as provided by University Magna Graecia:

Primary Outcome Measures:

Pregnancy rate [ Time Frame: 10 months ]

Secondary Outcome Measures:

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

Enrollment:	80
Study Start Date:	May 2006
Study Completion Date:	March 2007

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.

Eligibility

Ages Eligible for Study:	18 Years to 41 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00471523

Locations

Italy
"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

More Information

Publications:

Palomba S, Orio F Jr, Falbo A, Manguso F, Russo T, Cascella T, Tolino A, Carmina E, Colao A, Zullo F. Prospective parallel randomized, double-blind, double-dummy controlled clinical trial comparing clomiphene citrate and metformin as the first-line treatment for ovulation induction in nonobese anovulatory women with polycystic ovary syndrome. J Clin Endocrinol Metab. 2005 Jul;90(7):4068-74. Epub 2005 Apr 19.

Palomba S, Orio F Jr, Falbo A, Russo T, Tolino A, Zullo F. Effects of metformin and clomiphene citrate on ovarian vascularity in patients with polycystic ovary syndrome. Fertil Steril. 2006 Dec;86(6):1694-701. Epub 2006 Oct 30.

Palomba S, Orio F, Zullo F. Ovulation induction in women with polycystic ovary syndrome. Fertil Steril. 2006 Jul;86 Suppl 1:S26-7.

Palomba S, Russo T, Orio F Jr, Falbo A, Manguso F, Sammartino A, Tolino A, Colao A, Carmina E, Zullo F. Uterine effects of clomiphene citrate in women with polycystic ovary syndrome: a prospective controlled study. Hum Reprod. 2006 Nov;21(11):2823-9. Epub 2006 Jul 10.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Palomba S, Falbo A, Orio F Jr, Tolino A, Zullo F. Efficacy predictors for metformin and clomiphene citrate treatment in anovulatory infertile patients with polycystic ovary syndrome. Fertil Steril. 2009 Jun;91(6):2557-67. Epub 2008 Apr 28.

ClinicalTrials.gov Identifier:	NCT00471523 History of Changes
Other Study ID Numbers:	02-2006
Study First Received:	May 8, 2007
Last Updated:	May 8, 2007
Health Authority:	Italy: The Italian Medicines Agency

Keywords provided by University Magna Graecia:

Anovulation
Clomiphene citrate
Infertility

Metformin
PCOS
Treatment

Additional relevant MeSH terms:

Anovulation
Infertility
Polycystic Ovary Syndrome
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Genital Diseases, Male
Ovarian Cysts
Cysts
Neoplasms
Citric Acid
Clomiphene
Metformin

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 February 09, 2012