In Vitro Fertilization Outcomes in Metabolic Syndrome

This study is not yet open for participant recruitment.
Verified October 2013 by Meir Medical Center
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01958424
First received: October 6, 2013
Last updated: October 9, 2013
Last verified: October 2013
  Purpose

The purpose of this study is to examine the effect of metabolic syndrome in over-weight women on IVF treatment outcomes.


Condition
Metabolic Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Influence of Metabolic Syndrome on in Vitro Fertilization Treatment Outcome

Resource links provided by NLM:


Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • success or failure of ivf treatment [ Time Frame: within 1 year from intiation of ivf treatment ] [ Designated as safety issue: No ]
    success or failure of a treatment will be determined by beta-Human chorionic gonadotropin test, number of oocyte retrieved or fertilized and embryos quality.


Secondary Outcome Measures:
  • blood levels of C-reactive protein [ Time Frame: within 1 year from initiation of ivf treatment ] [ Designated as safety issue: No ]
  • follicle liquid levels of C-reactive protein [ Time Frame: within 1 year from initiation of ivf treatment ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

whole blood


Estimated Enrollment: 20
Study Start Date: April 2014
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
women with metabolic syndrome
women undergoing ivf treatment who have BMI>25 and meet the criteria for metabolic syndrome
women without metabolic syndrome
women undergoing ivf treatment who have BMI>25 and who do not meet the criteria for metabolic syndrome

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

women undergoing ivf treatment in "Meir" medical center in "Kfar-Saba, Israel

Criteria

Inclusion Criteria:

  • women undergoing ivf treatment

Exclusion Criteria:

  • inflammatory disease
  • acute conditions
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01958424

Locations
Israel
Sapir Medical Center, Meir Hospital Not yet recruiting
Kfar-Saba, Israel
Contact: Einat Haikin Herzberger, M.D       einatcha1@yahoo.com   
Sub-Investigator: Einat Haikin Herzberger, M.D         
Sponsors and Collaborators
Meir Medical Center
Investigators
Principal Investigator: Amir Waiser, M.D "Meir", Medical centere
  More Information

No publications provided

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01958424     History of Changes
Other Study ID Numbers: MMC-16092013-CTIL
Study First Received: October 6, 2013
Last Updated: October 9, 2013
Health Authority: Israel: Ethics Commission

Keywords provided by Meir Medical Center:
metabolic syndrome
in vitro fertilization
c reactive protein
over-weight women
ovarian stimulation

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on April 17, 2014