NCT01480024

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

April 1, 2011

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 23, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 28, 2011

Completed
7.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 2, 2019

Completed
Last Updated

December 20, 2023

Status Verified

December 1, 2023

Enrollment Period

8.1 years

First QC Date

November 23, 2011

Last Update Submit

December 18, 2023

Conditions

Healthy

Keywords

healthy womenoocytesin vitro fertilizationpregnancychildbearing-age

Outcome Measures

Primary Outcomes (1)

  • oocyte gene expression profile

    1-2 weeks

Eligibility Criteria

Age18 Years - 38 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

women of childbearing age undergoing fertility treatment

You may qualify if:

  • BMI \< 25 (N=35) or BMI ≥ 30 (N=35)
  • Seeking fertility treatment at the Arkansas Fertility and Gynecology Associates Clinic
  • Assisted reproduction will include the oocyte retrieval technique
  • to 38 years of age

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arkansas Children's Nutrition Center

Little Rock, Arkansas, 72202, United States

Location

Related Publications (1)

  • Ruebel ML, Cotter M, Sims CR, Moutos DM, Badger TM, Cleves MA, Shankar K, Andres A. Obesity Modulates Inflammation and Lipid Metabolism Oocyte Gene Expression: A Single-Cell Transcriptome Perspective. J Clin Endocrinol Metab. 2017 Jun 1;102(6):2029-2038. doi: 10.1210/jc.2016-3524.

    PMID: 28323970DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

oocytes and follicular fluid

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2011

First Posted

November 28, 2011

Study Start

April 1, 2011

Primary Completion

May 2, 2019

Study Completion

May 2, 2019

Last Updated

December 20, 2023

Record last verified: 2023-12

Locations

US(1)