Comparison Between Two Fertility Protocols in Obese Polycystic Ovary Syndrome Patients

NCT ID: NCT01473459

Last Updated: 2012-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2013-01-31

Brief Summary

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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

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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.

Conditions

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Obese Infertility Polycystic Ovary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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IVM Treatment

Group Type ACTIVE_COMPARATOR

IVM (In Vitro Maturation) Treatment

Intervention Type PROCEDURE

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.

Antagonist Protocol

Group Type ACTIVE_COMPARATOR

IVF (In Vitro Fertilization) Antagonist Protocol

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Other Intervention Names

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IVM IVF - antagonist protocol

Eligibility Criteria

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Inclusion Criteria

* BMI \> 30
* PCOS
* Failure of COH treatment
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hillel Yaffe Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tal Shavit, M.D

Role: PRINCIPAL_INVESTIGATOR

IVF unit Hillel-Yaffe medical Center

Locations

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Hillel Yaffe Medical Center

Hadera, , Israel

Site Status

Countries

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Israel

Central Contacts

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Tal Shavit, MD

Role: CONTACT

972-50-6246712

Other Identifiers

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0078-11-HYMC

Identifier Type: -

Identifier Source: org_study_id

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