The MOM TO BE Study

Not Applicable

Terminated

• Conditions: Infertility, Female
• Interventions: Other: Diet Intervention - Group 1; Other: Exercise Intervention - Group 1

• Registration Number: NCT04273048
• Lead Sponsor: Arkansas Children's Hospital Research Institute

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2019-11-13
• Study First Submitted QC: 2020-02-14
• Study First Posted: 2020-02-17
• Study Start: 2020-07-21
• Primary Completion: 2022-06-21
• Study Completion: 2022-06-21
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 14

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diet and Exercise	Exercise Intervention - Group 1	Group 1 = Diet Intervention group: They will be asked to follow a personalized diet during study period and record what they eat. The meal plan for this study is Mediterranean style and nutritionally complete for 8 to 12 weeks or until oocyte retrieval procedure. Exercise Intervention: Exercise 3 times/week at a gym of their choice or at home for 8 to 12 weeks or until oocyte retrieval procedure. Exercises will be light intensity and short duration at first and will gradually increase to moderate intensity and longer duration during the first 3 weeks. They will also be encouraged to walk an average 10,000 steps per day and wear a pedometer to monitor progress.
Diet and Exercise	Diet Intervention - Group 1	Group 1 = Diet Intervention group: They will be asked to follow a personalized diet during study period and record what they eat. The meal plan for this study is Mediterranean style and nutritionally complete for 8 to 12 weeks or until oocyte retrieval procedure. Exercise Intervention: Exercise 3 times/week at a gym of their choice or at home for 8 to 12 weeks or until oocyte retrieval procedure. Exercises will be light intensity and short duration at first and will gradually increase to moderate intensity and longer duration during the first 3 weeks. They will also be encouraged to walk an average 10,000 steps per day and wear a pedometer to monitor progress.

Primary Outcome Measures

Name	Time	Method
Oocyte gene expression profile	8-12 weeks	Oocyte gene expression
Follicular fluid content	8-12 weeks	Follicular fluid content

Trial Locations

Locations (1)

Arkansas Children's Nutrition Center; 🇺🇸 Little Rock, Arkansas, United States