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Comparison Between Two Fertility Protocols in Obese Polycystic Ovary Syndrome Patients

Primary Purpose

Obese, Infertility, Polycystic Ovary Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
IVM (In Vitro Maturation) Treatment
IVF (In Vitro Fertilization) Antagonist Protocol
Sponsored by
Hillel Yaffe Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obese focused on measuring best fertility protocol, (BMI > 30), women, PCOS

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • BMI > 30
  • PCOS
  • Failure of COH treatment

Sites / Locations

  • Hillel Yaffe Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

IVM Treatment

Antagonist Protocol

Arm Description

Outcomes

Primary Outcome Measures

Fertility results

Secondary Outcome Measures

Full Information

First Posted
November 14, 2011
Last Updated
April 25, 2012
Sponsor
Hillel Yaffe Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01473459
Brief Title
Comparison Between Two Fertility Protocols in Obese Polycystic Ovary Syndrome Patients
Official Title
Comparison Between Two Fertility Protocols in Obese Polycystic Ovary Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Unknown status
Study Start Date
April 2012 (undefined)
Primary Completion Date
January 2013 (Anticipated)
Study Completion Date
January 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hillel Yaffe Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obese, Infertility, Polycystic Ovary Syndrome
Keywords
best fertility protocol, (BMI > 30), women, PCOS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IVM Treatment
Arm Type
Active Comparator
Arm Title
Antagonist Protocol
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
IVM (In Vitro Maturation) Treatment
Other Intervention Name(s)
IVM
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
IVF (In Vitro Fertilization) Antagonist Protocol
Other Intervention Name(s)
IVF - antagonist protocol
Intervention Description
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.
Primary Outcome Measure Information:
Title
Fertility results
Time Frame
One year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: BMI > 30 PCOS Failure of COH treatment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tal Shavit, MD
Phone
972-50-6246712
Email
tal.shavit@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tal Shavit, M.D
Organizational Affiliation
IVF unit Hillel-Yaffe medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hillel Yaffe Medical Center
City
Hadera
ZIP/Postal Code
38100
Country
Israel

12. IPD Sharing Statement

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Comparison Between Two Fertility Protocols in Obese Polycystic Ovary Syndrome Patients

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