HealthyNCT01480024
Effect of Body Composition and Metabolism on Oocyte Gene Expression
An observational study of Healthy, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 38 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to 2 May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 38 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: women of childbearing age undergoing fertility treatment
Who may be able to join
- 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
Who cannot join
- Any health condition or medication that may interfere with the study outcome as determined by the investigators
Trial locations and contacts
1 site in 1 country.
United States1 site
Arkansas Children's Nutrition Center
Little Rock, Arkansas, 72202
About this study
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.
- Conditions
- Healthy
- Keywords
- healthy women, oocytes, in vitro fertilization, pregnancy, childbearing-age
What is being measured
The primary outcome is the main question the study is designed to answer.
oocyte gene expression profile
Measured: 1-2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2011 (estimated)
- Study startApr 2011
- Primary completion2 May 2019
- Study completion2 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arkansas Children's Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01480024
- Sponsor's protocol ID
- 131386
- Status last verified
- Dec 2023
- First submitted
- 23 Nov 2011
- Last updated
- 20 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28323970
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Body Composition and Metabolism on Oocyte Gene Expression
- ClinicalTrials.gov ID
- NCT01480024
- Acronym / sponsor ID
- 131386
- Conditions
- Healthy
- Keywords
- healthy women, oocytes, in vitro fertilization, pregnancy, childbearing-age
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Arkansas Children's Hospital Research InstituteUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- 2 May 2019 (actual)
- Study completion
- 2 May 2019 (actual)
- First posted
- 28 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- women of childbearing age undergoing fertility treatment
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Any health condition or medication that may interfere with the study outcome as determined by the investigators
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
oocyte gene expression profile
Time frame: 1-2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
- Derived from this study: PubMed 28323970Ruebel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
oocyte gene expression profile (time frame: 1-2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01480024, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2023.