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NCT04273048 Clinical Trial

The MOM TO BE Study

Infertility, Female Clinical Trial

Official title:
A Dietary and Exercise Intervention in Overweight and Obese Women Undergoing Fertility Treatment

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT04273048
Other study ID # 260113
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date July 21, 2020
Est. completion date June 21, 2022

Study information
Verified date May 2024
Source Arkansas Children's Hospital Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This research study is about the effects of diet and exercise in women undergoing fertility treatment.

Description:

This study will randomize women who are undergoing fertility treatment and put them either in an intervention group or standard care. This study should help us learn if diet and exercise changes oocytes gene expression and follicular fluid content.

Recruitment information / eligibility
Status Terminated
Enrollment 14
Est. completion date June 21, 2022
Est. primary completion date June 21, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 21 Years and older
Eligibility Inclusion Criteria: - BMI 25 - 45 kg/m2 - = 21 years of age Exclusion Criteria: - Pre-existing conditions (e.g. sexual transmitted diseases) that will affect the outcomes of the study as determined by the principal investigator - Current use of recreational drugs, tobacco, or alcohol - Food allergies, intolerances or preferences which would interfere with compliance to the meal plan - Contraindications to exercise - Already meeting the physical activity guidelines (150 min moderate activity/week or 75 minutes of vigorous activity/week with resistance exercise on 2 or more days/week).

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Diet Intervention - Group 1
They will be provided with a Mediterranean diet plan.
• Exercise Intervention - Group 1
They will be provided with an exercise plan to follow.

Locations
Country Name City State
United States Arkansas Children's Nutrition Center Little Rock Arkansas

Sponsors (1)
Lead Sponsor Collaborator
Arkansas Children's Hospital Research Institute

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Oocyte gene expression profile Oocyte gene expression 8-12 weeks
Primary Follicular fluid content Follicular fluid content 8-12 weeks
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