Effect of Body Composition and Metabolism on Oocyte Gene... | NCT01480024

Studies
Effect of Body Composition and Metabolism on Oocyte Gene Expression

NCT01480024

Sponsor

Arkansas Children's Hospital Research Institute

Status

Completed

Last Update Posted

Dec 20, 2023Actual

Enrollment

46Actual

Phase

Not provided

Conditions

Healthy

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2011

Primary Completion Date

May 2, 2019Actual

Completion Date

May 2, 2019Actual

First Submitted Date

Nov 23, 2011

First Submission Date that Met QC Criteria

Nov 25, 2011

First Posted Date

Nov 28, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 18, 2023

Last Update Posted Date

Dec 20, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

46Actual

Measure	Description	Time Frame
oocyte gene expression profile		1-2 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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
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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

38 Years

Standard Ages

Adult

Study Population

women of childbearing age undergoing fertility treatment

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Arkansas Children's Nutrition Center		Little Rock	Arkansas	72202	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28323970	Derived	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.