Text Size

Comparison Between Two Fertility Protocols in Obese Polycystic Ovary Syndrome Patients

This study is not yet open for participant recruitment.
Verified April 2012 by Hillel Yaffe Medical Center
Sponsor:
Information provided by (Responsible Party):
Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier:
NCT01473459
First received: November 14, 2011
Last updated: April 25, 2012
Last verified: April 2012
History of Changes

November 14, 2011
April 25, 2012
April 2012
January 2013   (final data collection date for primary outcome measure)
Fertility results [ Time Frame: One year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01473459 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Comparison Between Two Fertility Protocols in Obese Polycystic Ovary Syndrome Patients
Comparison Between Two Fertility Protocols in Obese Polycystic Ovary Syndrome

The purpose of this study is to compare two fertility protocols in obese women with Polycystic Ovarian Syndrome who are candidates for In Vitro Fertilization (IVF). These protocols carry less risk of ovarian hyperstimulation syndrome which these women may experience.

The purpose of this study is to compare two fertility protocols in obese women with Polycystic Ovarian Syndrome who are candidates for In Vitro Fertilization (IVF). These protocols carry less risk of ovarian hyperstimulation syndrome which these women may experience.The patients in the IVM group will not be exposeD to gonadotropin treatment for controlled ovarian hyperstimulation. In the antagonist group we will use GnRH agonist to induce ovulation which may reduce the risk for ovarian hyperstimulation.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Obese
  • Infertility
  • Polycystic Ovary Syndrome
  • Procedure: IVM (In Vitro Maturation) Treatment
    There will be no gonadotropin stimulation. There will be ovum pickup from antral follicles of immature oocyte which will be matured in the lab and fertilized by intracytoplasmic sperm injection (ICSI). Embryo transfer will take place on days 2 or 3.
    Other Name: IVM
  • Procedure: IVF (In Vitro Fertilization) Antagonist Protocol
    The first stage of the treatment will be stimulation with gonadotropins. Next GNRH Antagonist will be added. Ovulation induction will be performed with GNRH agonist. After ovulation there will be ovum pickup and fertilization in the lab. Embryo transfer will take place on days 2 or 3.
    Other Name: IVF - antagonist protocol
  • Active Comparator: IVM Treatment
    Intervention: Procedure: IVM (In Vitro Maturation) Treatment
  • Active Comparator: Antagonist Protocol
    Intervention: Procedure: IVF (In Vitro Fertilization) Antagonist Protocol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
40
January 2013
January 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • BMI > 30
  • PCOS
  • Failure of COH treatment
Female
18 Years to 40 Years
Yes
Contact: Tal Shavit, MD 972-50-6246712 tal.shavit@gmail.com
Israel
 
NCT01473459
0078-11-HYMC
Yes
Hillel Yaffe Medical Center
Hillel Yaffe Medical Center
Not Provided
Principal Investigator: Tal Shavit, M.D IVF unit Hillel-Yaffe medical Center
Hillel Yaffe Medical Center
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP