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Effect of Body Composition and Metabolism on Oocyte Gene Expression

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Arkansas Children's Hospital Research Institute
Sponsor:
Information provided by (Responsible Party):
Arkansas Children's Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT01480024
First received: November 23, 2011
Last updated: October 20, 2014
Last verified: October 2014
  Purpose

The investigators will test the hypothesis that obese women have a unique oocyte gene expression profile that differs significantly from that of lean women.


Condition
Healthy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Body Composition and Metabolism on Oocyte Gene Expression

Resource links provided by NLM:


Further study details as provided by Arkansas Children's Hospital Research Institute:

Primary Outcome Measures:
  • oocyte gene expression profile [ Time Frame: 1-2 weeks ] [ Designated as safety issue: No ]
    whether women with different body compositions produce oocyte with significantly different gene expression profiles


Biospecimen Retention:   Samples With DNA

oocytes and follicular fluid


Estimated Enrollment: 40
Study Start Date: April 2011
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Detailed Description:

Participants will attend one study visit at the Arkansas Children's Nutrition Center to collect baseline data. Following this visit, oocytes will be obtained from oocyte retrieval procedures performed at the Arkansas Fertility and Gynecology Associates Clinic.

  Eligibility

Ages Eligible for Study:   18 Years to 38 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

women of childbearing age undergoing fertility treatment

Criteria

Inclusion Criteria:

  • BMI < 25 (N=20) or BMI ≥ 30 (N=20)
  • Seeking fertility treatment at the Arkansas Fertility and Gynecology Associates Clinic
  • Assisted reproduction will include the oocyte retrieval technique
  • 18 to 38 years of age

Exclusion Criteria:

  • Any health condition or medication that may interfere with the study outcome as determined by the investigators
  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: NCT01480024

Contacts
Contact: Jill Harsch, BS 501-364-3309 acncstudies@uams.edu

Locations
United States, Arkansas
Arkansas Children's Nutrition Center Recruiting
Little Rock, Arkansas, United States, 72202
Contact: Amanda Garner, BS    501-364-3309    acncstudies@uams.edu   
Principal Investigator: Aline Andres, PhD         
Sub-Investigator: Kartik Shankar, PhD         
Sub-Investigator: Thomas Badger, PhD         
Sponsors and Collaborators
Arkansas Children's Hospital Research Institute
  More Information

No publications provided

Responsible Party: Arkansas Children's Hospital Research Institute
ClinicalTrials.gov Identifier: NCT01480024     History of Changes
Other Study ID Numbers: 131386
Study First Received: November 23, 2011
Last Updated: October 20, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Arkansas Children's Hospital Research Institute:
healthy women
oocytes
in vitro fertilization
pregnancy
childbearing-age

ClinicalTrials.gov processed this record on November 20, 2014