Infertility, FemaleNCT04273048
The MOM TO BE Study
A study testing Diet Intervention - Group 1 and Exercise Intervention - Group 1 in people with Infertility, Female, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
Trial summary
This research study is about the effects of diet and exercise in women undergoing fertility treatment. Read more about this study
- Who is it for?
- Ages 21 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Female
- What is being tested?
- Diet Intervention - Group 1 and Exercise Intervention - Group 1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jul 2020to 21 Jun 2022
- Phase
- Interventional
- 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 21 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI 25 - 45 kg/m2
- ≥ 21 years of age
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Arkansas Children's Nutrition Center
Little Rock, Arkansas, 72203
About this study
Official title: A Dietary and Exercise Intervention in Overweight and Obese Women Undergoing Fertility Treatment
This research study is about the effects of diet and exercise in women undergoing fertility treatment.
Read the 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.
- Conditions
- Infertility, Female
- Being tested
- Diet Intervention - Group 1, Exercise Intervention - Group 1
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet Intervention - Group 1Other
They will be provided with a Mediterranean diet plan.
Exercise Intervention - Group 1Other
They will be provided with an exercise plan to follow.
| Study group | Role | What they receive |
|---|---|---|
| Diet and Exercise | Active comparator | 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. Receives: Other: Diet Intervention - Group 1; Other: Exercise Intervention - Group 1 |
| Standard Care | No intervention | Group 2 = Standard: They will receive standard care from the Little Rock Fertility Center. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oocyte gene expression profile
Oocyte gene expression
Measured: 8-12 weeks
Follicular fluid content
Follicular fluid content
Measured: 8-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start21 Jul 2020
- Primary completion21 Jun 2022
- Study completion21 Jun 2022
Why it stopped: Study Terminated due to slow accrual or other non-safety related issues.
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 Infertility, FemaleStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This research will last up to 12 weeks. The participant will attend two research study visits and will be asked to donate oocytes and follicular fluid to the study team during their oocyte retrieval procedures. They will be randomized (like flipping a coin) to either a standard of care group or an intervention group. If they are in the intervention group, they will also be asked to follow a Mediterranean diet (all meals will be shipped to their home weekly) and exercise at least 3 times a week at a gym or at their house. If they are in the control group, they will follow the normal fertility clinic procedures.
- Masking
- None (open label)
- Enrolment
- 14 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
- NCT04273048
- Sponsor's protocol ID
- 260113
- Status last verified
- May 2024
- First submitted
- 13 Nov 2019
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fawcett K, Martinez A, Crimmins M, Sims C, Borsheim E, Andres A. Effect of a dietary and exercise intervention in women with overweight and obesity undergoing fertility treatments: protocol for a randomized controlled trial. BMC Nutr. 2021 Aug 17;7(1):51. doi: 10.1186/s40795-021-00454-y.
PubMed 34399856
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dietary and Exercise Intervention in Overweight and Obese Women Undergoing Fertility Treatment
- ClinicalTrials.gov ID
- NCT04273048
- Acronym / sponsor ID
- 260113
- Conditions
- Infertility, Female
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study Terminated due to slow accrual or other non-safety related issues.
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Arkansas Children's Hospital Research InstituteUniversity, hospital or other
- Study start
- 21 Jul 2020 (actual)
- Primary completion
- 21 Jun 2022 (actual)
- Study completion
- 21 Jun 2022 (actual)
- First posted
- 17 Feb 2020 (actual)
- 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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This research will last up to 12 weeks. The participant will attend two research study visits and will be asked to donate oocytes and follicular fluid to the study team during their oocyte retrieval procedures. They will be randomized (like flipping a coin) to either a standard of care group or an intervention group. If they are in the intervention group, they will also be asked to follow a Mediterranean diet (all meals will be shipped to their home weekly) and exercise at least 3 times a week at a gym or at their house. If they are in the control group, they will follow the normal fertility clinic procedures.
| Arm | Type | Receives |
|---|---|---|
| Diet and Exercise | Active comparator | Other: Diet Intervention - Group 1, Other: Exercise Intervention - Group 1Group 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. |
| Standard Care | No intervention | –Group 2 = Standard: They will receive standard care from the Little Rock Fertility Center. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- BMI 25 - 45 kg/m2
- ≥ 21 years of age
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diet Intervention - Group 1They will be provided with a Mediterranean diet plan. | Other | Diet and Exercise |
| Exercise Intervention - Group 1They will be provided with an exercise plan to follow. | Other | Diet and Exercise |
Primary outcome
Oocyte gene expression profile
Time frame: 8-12 weeks
Oocyte gene expression
Follicular fluid content
Time frame: 8-12 weeks
Follicular fluid content
Results and safety
The study was stopped early (reason given: Study Terminated due to slow accrual or other non-safety related issues.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Derived from this study: PubMed 34399856Fawcett K, Martinez A, Crimmins M, Sims C, Borsheim E, Andres A. Effect of a dietary and exercise intervention in women with overweight and obesity undergoing fertility treatments: protocol for a randomized controlled trial. BMC Nutr. 2021 Aug 17;7(1):51. doi: 10.1186/s40795-021-00454-y.
- Individual participant dataSharing planned: No
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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?
A study testing Diet Intervention - Group 1 and Exercise Intervention - Group 1 in people with Infertility, Female, 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 2 inclusion and 5 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: stopped early, as of the sponsor's last update on 8 May 2024. 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 was stopped early (reason given: Study Terminated due to slow accrual or other non-safety related issues.). Results are not available in the source record.
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: 8-12 weeks). The study lists 2 primary outcomes in all. 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 NCT04273048, 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 8 May 2024.