In Vitro Fertilization Outcomes in Metabolic Syndrome

This study is not yet open for participant recruitment. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Syndrome
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Disease
Pathologic Processes

ClinicalTrials.gov processed this record on September 30, 2014