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Study Terminated due to slow accrual or other non-safety related issues.
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This research study is about the effects of diet and exercise in women undergoing fertility treatment.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Standard Care | No Intervention | Group 2 = Standard: They will receive standard care from the Little Rock Fertility Center. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diet Intervention - Group 1 | Other | They will be provided with a Mediterranean diet plan. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Oocyte gene expression profile | Oocyte gene expression | 8-12 weeks |
| Follicular fluid content | Follicular fluid content | 8-12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arkansas Children's Nutrition Center | Little Rock | Arkansas | 72203 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34399856 | Derived | 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. |
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| ID | Term |
|---|---|
| D007247 | Infertility, Female |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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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.
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| Exercise Intervention - Group 1 | Other | They will be provided with an exercise plan to follow. |
|
| D000091662 | Genital Diseases |
| D007246 | Infertility |