Comparison Between Two Fertility Protocols in Obese Polycystic Ovary Syndrome Patients - Full Text View

Purpose

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.

Condition	Intervention
Obese Infertility Polycystic Ovary Syndrome	Procedure: IVM (In Vitro Maturation) Treatment Procedure: IVF (In Vitro Fertilization) Antagonist Protocol

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Comparison Between Two Fertility Protocols in Obese Polycystic Ovary Syndrome

Resource links provided by NLM:

MedlinePlus related topics: Infertility Obesity Polycystic Ovary Syndrome

U.S. FDA Resources

Further study details as provided by Hillel Yaffe Medical Center:

Primary Outcome Measures:

Fertility results [ Time Frame: One year ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	April 2012
Estimated Study Completion Date:	January 2013
Estimated Primary Completion Date:	January 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: IVM Treatment	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
Active Comparator: Antagonist Protocol	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

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.

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

BMI > 30
PCOS
Failure of COH treatment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01473459

Contacts

Contact: Tal Shavit, MD

972-50-6246712

tal.shavit@gmail.com

Locations

Israel
Hillel Yaffe Medical Center
Hadera, Israel, 38100

Sponsors and Collaborators

Hillel Yaffe Medical Center

Investigators

Principal Investigator:

Tal Shavit, M.D

IVF unit Hillel-Yaffe medical Center

More Information

No publications provided

Responsible Party:	Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier:	NCT01473459 History of Changes
Other Study ID Numbers:	0078-11-HYMC
Study First Received:	November 14, 2011
Last Updated:	April 25, 2012
Health Authority:	Israel: Ministry of Health

Keywords provided by Hillel Yaffe Medical Center:

best fertility protocol
(BMI > 30)
women
PCOS

Additional relevant MeSH terms:

Infertility
Obesity
Polycystic Ovary Syndrome
Genital Diseases, Male
Genital Diseases, Female
Overnutrition
Nutrition Disorders
Overweight
Body Weight

Signs and Symptoms
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases

ClinicalTrials.gov processed this record on June 17, 2013