NCT01473459

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 17, 2011

Completed
5 months until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

April 26, 2012

Status Verified

April 1, 2012

Enrollment Period

9 months

First QC Date

November 14, 2011

Last Update Submit

April 25, 2012

Conditions

ObeseInfertilityPolycystic Ovary Syndrome

Keywords

best fertility protocol(BMI > 30)womenPCOS

Outcome Measures

Primary Outcomes (1)

  • Fertility results

    One year

Study Arms (2)

IVM Treatment

ACTIVE COMPARATOR
Procedure: IVM (In Vitro Maturation) Treatment

Antagonist Protocol

ACTIVE COMPARATOR
Procedure: IVF (In Vitro Fertilization) Antagonist Protocol

Interventions

IVM (In Vitro Maturation) TreatmentPROCEDURE

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.

Also known as: IVM
IVM Treatment
IVF (In Vitro Fertilization) Antagonist ProtocolPROCEDURE

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.

Also known as: IVF - antagonist protocol
Antagonist Protocol

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI \> 30
  • PCOS
  • Failure of COH treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe Medical Center

Hadera, 38100, Israel

Location

MeSH Terms

Conditions

ObesityInfertilityPolycystic Ovary Syndrome

Interventions

Intravital MicroscopyTherapeuticsFertilization in Vitro

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGenital DiseasesUrogenital DiseasesOvarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

MicroscopyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesReproductive Techniques, AssistedReproductive Techniques

Study Officials

  • Tal Shavit, M.D

    IVF unit Hillel-Yaffe medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tal Shavit, MD

CONTACT

972-50-6246712tal.shavit@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2011

First Posted

November 17, 2011

Study Start

April 1, 2012

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

April 26, 2012

Record last verified: 2012-04

Locations

IL(1)