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The goal of this clinical trial is to learn if mediterranean diet works to treat infertility in women. It will also learn about the initial and end of study zonulin levels of mediterranean diet and control group. The main questions it aims to answer are:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mediterranean diet group | Experimental | this group will apply mediterranean diet for 8 weeks |
|
| control group | No Intervention | this group will apply routine diet for 8 weeks |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mediterranean diet | Behavioral | All questions of the intervention group, in which behavioural change was expected, were answered by the dietitian throughout the study and compliance with the diet was monitored with food consumption records. |
| Measure | Description | Time Frame |
|---|---|---|
| intestinal permeability | serum zonulin levels | From enrollment to the end of treatment at 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| infertility outcomes | number of eggs collected | From enrollment to the end of treatment at 8 weeks |
| infertility outcomes | number of embryos formed |
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Inclusion Criteria:
Exclusion Criteria:
Women (research focussed on female infertility)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NovaArt | Ankara | Ankara | 06810 | Turkey (Türkiye) |
Data obtained through this study may be provided to qualified researchers with academic interest on infertility. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis
Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA)
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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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| ID | Term |
|---|---|
| D038441 | Diet, Mediterranean |
| ID | Term |
|---|---|
| D000095500 | Diet, Plant-Based |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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| From enrollment to the end of treatment at 8 weeks |
| D000091662 | Genital Diseases |
| D007246 | Infertility |
| D004032 |
| Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |