Strategies for Ovulation Induction in Anovulatory Infertile Patients With PCOS

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by University Magna Graecia
Sponsor:
Information provided by (Responsible Party):
Stefano Palomba, University Magna Graecia
ClinicalTrials.gov Identifier:
NCT00461643
First received: April 13, 2007
Last updated: April 5, 2013
Last verified: April 2013
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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:


Further study details as provided by University Magna Graecia:

Primary Outcome Measures:
  • Multiple pregnancy rate [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Ovulation rate [ Time Frame: 15 months ] [ Designated as safety issue: No ]
  • Pregnancy rate [ Time Frame: 15 months ] [ Designated as safety issue: No ]
  • Abortion rate [ Time Frame: 15 months ] [ Designated as safety issue: Yes ]
  • Live-birth rate [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Adverse-events [ Time Frame: 15 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 552
Study Start Date: January 2007
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Strategy A
clomiphene followed by clomiphene plus metformin followed by gonadotropins
Drug: Clomiphene citrate, metformin, metformin plus clomiphene citrate, gonadotropins
Active Comparator: Strategy B
metformin followed by metformin plus clomiphene followed by gonadotropins
Drug: Clomiphene citrate, metformin, metformin plus clomiphene citrate, gonadotropins
Active Comparator: Strategy C
metformin plus clomiphene followed by gonadotropins
Drug: Clomiphene citrate, metformin, metformin plus clomiphene citrate, gonadotropins

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Responsible Party: Stefano Palomba, Associate Professor, University Magna Graecia
ClinicalTrials.gov Identifier: NCT00461643     History of Changes
Other Study ID Numbers: 01/2007
Study First Received: April 13, 2007
Last Updated: April 5, 2013
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
Polycystic Ovary Syndrome
Genital Diseases, Male
Genital Diseases, Female
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
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
Hypoglycemic Agents

ClinicalTrials.gov processed this record on July 22, 2014