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Completed

NCT Number: NCT06559904

The Effect of the Mediterranean Diet on Fatty Acids in Biological Fluids of Women Undergoing Infertility Treatment

The aim of this study was to examine the effect of the Mediterranean diet, which is accepted as one of the adequate and balanced nutrition models today, as well as serum and follicular fluid fatty acid profile and implantation success in women with an age range of 19-40 (years) before infertility treatment. The study was conducted as a prospective and case-control study with a total of 32 volunteer women, 16 in the intervention group and 16 in the control group, who applied to Gazi University Hospital between February 2021 and February 2022.

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Key information

Conditions

Women Diagnosed With Infertility Genital Diseases Infertility Urogenital Diseases

Age range

19 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Gazi University

Ankara, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Women diagnosed with infertility Women between the ages of 19-40 Women with BMI <30 kg/m² women undergoing assisted reproductive treatment in which updated oocytes and semen be used Women undergoing assisted reproductive treatment (ART), IUI or one of the first 3 IVF/ICSI treatments (number of ART treatments ≤ 3)

Exclusion criteria

Women diagnosed with chronic diseases other than infertility Women who smoke and drink alcohol Women on ART who will use frozen eggs or semen Women with BMI >30 kg/m2 at the first measurement Women experiencing communication breakdown/timeout, becoming pregnant, difficulty adhering to a diet program or ART while the intervention is ongoing

Treatment and study plan

Mediterranean Diet

Other

The 'Mediterranean Diet Education Document', prepared by the researcher, which includes general information about the characteristics of the Mediterranean diet and the portion sizes that should be followed daily and weekly, and information on how often, how much and when to consume food groups, was provided as a diet education, and information was provided on how to record three-day food consumption.

A nutrition education compatible with the Mediterranean diet, organized by the researcher according to the individual's daily needs, was provided and a sample menu was explained to the individual face to face.

Primary outcomes

  1. first meeting

    Time frame: through study completion, an average of 1 year

    using the questionnaire form, applying anthropometric measurements, drawing blood samples, and recording food intake for three days

  2. second meeting

    Time frame: through study completion, an average of 1 year

    An explanation of the individual Mediterranean diet

  3. third and forth meeting

    Time frame: through study completion, an average of 1 year

    recording three-day food intake evaluate adherence to the Mediterranean diet using anthropometric measurements

  4. fifth meeting

    Time frame: through study completion, an average of 1 year

    using the questionnaire form, applying anthropometric measurements, drawing blood samples, and recording food intake for three days, collecting follicular fluid samples

Secondary outcomes

  1. analysis of blood and follicular fluid samples

    Time frame: through study completion, an average of 1 year

    Fatty acid analyses of the collected samples were performed by gas chromatography-flame ionization detector (GC-FID) at Gazi University Faculty of Pharmacy.

Sponsors and collaborators

Lead sponsor

Trakya University

Other

Collaborators

  • Gazi University

Registry information

Official study title

The Effect of Dıetary Interventıon in Adherence With The Medıterranean Dıet on Fatty Acid Parameters in Blood and Follicular Fluid Samples and Implantation Success in Women Undergoing Infertility Treatment

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Aug 19, 2024
Registry last updated
Aug 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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