Strategies for Ovulation Induction in Anovulatory Infertile Patients With PCOS - Full Text View

Sponsor:	University Magna Graecia
Information provided by:	University Magna Graecia
ClinicalTrials.gov Identifier:	NCT00461643

Purpose

Anovulatory infertility is a common feature of the polycystic ovary syndrome (PCOS). Even if several first-step treatments have been proposed for anovulatory infertile PCOS patients, very few data are available in literature regarding the best integrated strategy. In fact, a single compound could be effective as first-step approach but not or less useful when integrated in a more complex strategy.

The goal of the current protocol will be to compare three different strategies for treating anovulatory infertility in PCOS patients having as primary end-point the multiple pregnancy rate.

Condition	Intervention	Phase
Anovulatory Infertility Related to Polycystic Ovary Syndrome	Drug: Clomiphene citrate, metformin, metformin plus clomiphene citrate, gonadotropins	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study
Official Title:	Comparison of Three Different Strategies for Treating Infertility in Anovulatory Women With Polycystic Ovary Syndrome: a Multicentre Randomized Controlled Clinical Trial

Resource links provided by NLM:

MedlinePlus related topics: Infertility

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:

Multiple pregnancy rate

Secondary Outcome Measures:

Ovulation rate
Pregnancy rate
Abortion rate
Live-birth rate
Adverse-events

Estimated Enrollment:	552
Study Start Date:	January 2007
Estimated Study Completion Date:	October 2009

Detailed Description:

All patients eligible will undergo baseline assessment consisting of antropometric, hormonal, and ultrasonographic assessments. Successively, patients enrolled will be allocated in three different strategies (strategy A, B, and C).

A total of 184 infertile PCOS patients per arm will be enrolled and treated with three different integrated strategies: clomiphene followed by clomiphene plus metformin followed by gonadotropins (strategy A); metformin followed by metformin plus clomiphene followed by gonadotropins(strategy B); and metformin plus clomiphene followed by gonadotropins(strategy C).

In all patients, the same regimen will be used to administered clomiphene, metformin, and gonadotropins.Both clomiphene and metformin will be administered at incremental doses in each case.Gonadotropins will be administrated to obtain a controlled ovarian stimulation using highly purified urinary FSH in a low-dose step-up protocol.

During the study, the clinical and reproductive outcomes, and adverse experiences will be evaluated in each woman.

Eligibility

Ages Eligible for Study:	18 Years to 35 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Polycystic ovary syndrome (using ESHRE/ARSM 2004 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
Previous use of ovulation induction agents
Intention to start a diet or a specific program of physical activity
No uterine bleeding after progesterone challenge test
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: NCT00461643

Contacts

Contact: Stefano Palomba, MD

+39-0961.883234

stefanopalomba@tin.it

Locations

Italy
"Pugliese" Hospital	Recruiting
Catanzaro, Italy, 88100
Contact: Ingrid Tomaino, MD +39 0961 883234 angela.falbo@libero.it
Principal Investigator: Stefano Palomba, MD
"Pugliese" Hospital	Recruiting
Catanzaro, Italy, 88100
Contact: Ingrid Tomaino, MD +39 0961 883234 zullo@unicz.it
Principal Investigator: Stefano Palomba, MD
Principal Investigator: Francesco Orio, MD
Principal Investigator: Achille Tolino, MD
Principal Investigator: Pasquale Mastrantonio, MD
Principal Investigator: Brian Dale, MD
Principal Investigator: Ettore Cittadini, MD
Principal Investigator: Andrea Riccardo Genazzani, MD
Pugliese-Ciaccio Hospital	Recruiting
Catanzaro, Italy, 88100
Contact: , MD

Sponsors and Collaborators

University Magna Graecia

Investigators

Principal Investigator:

Stefano Palomba, MD

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

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.

Moll E, Bossuyt PM, Korevaar JC, Lambalk CB, van der Veen F. Effect of clomifene citrate plus metformin and clomifene citrate plus placebo on induction of ovulation in women with newly diagnosed polycystic ovary syndrome: randomised double blind clinical trial. BMJ. 2006 Jun 24;332(7556):1485. Epub 2006 Jun 12.

Legro RS, Barnhart HX, Schlaff WD, Carr BR, Diamond MP, Carson SA, Steinkampf MP, Coutifaris C, McGovern PG, Cataldo NA, Gosman GG, Nestler JE, Giudice LC, Leppert PC, Myers ER; Cooperative Multicenter Reproductive Medicine Network. Clomiphene, metformin, or both for infertility in the polycystic ovary syndrome. N Engl J Med. 2007 Feb 8;356(6):551-66.

Study ID Numbers:	01/2007
Study First Received:	April 13, 2007
Last Updated:	April 25, 2007
ClinicalTrials.gov Identifier:	NCT00461643 History of Changes
Health Authority:	Italy: The Italian Medicines Agency

Keywords provided by University Magna Graecia:

Anovulation
Clomiphene citrate
Infertility
Metformin

PCOS
RCT
Treatment

Additional relevant MeSH terms:

Infertility
Molecular Mechanisms of Pharmacological Action
Gonadal Disorders
Hormone Antagonists
Physiological Effects of Drugs
Hematologic Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Clomiphene
Reproductive Control Agents
Ovarian Diseases
Selective Estrogen Receptor Modulators
Genital Diseases, Female
Estrogen Receptor Modulators
Hypoglycemic Agents
Pathologic Processes

Syndrome
Therapeutic Uses
Estrogen Antagonists
Disease
Anticoagulants
Citric Acid
Metformin
Endocrine System Diseases
Cysts
Genital Diseases, Male
Pharmacologic Actions
Adnexal Diseases
Neoplasms
Fertility Agents, Female
Fertility Agents

ClinicalTrials.gov processed this record on February 08, 2010