Effect of Body Composition and Metabolism on Oocyte Gene Expression
This study is currently recruiting participants.
Verified January 2013 by Arkansas Children's Hospital Research Institute
Sponsor:
Arkansas Children's Hospital Research Institute
Information provided by (Responsible Party):
Arkansas Children's Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT01480024
First received: November 23, 2011
Last updated: January 28, 2013
Last verified: January 2013
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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 |
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 Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
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
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: Rebecca Carter, MBA 501-364-2314 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: | January 28, 2013 |
| 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 May 19, 2013