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

NCT ID: NCT06559904

Last Updated: 2024-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-01

Study Completion Date

2023-11-02

Brief Summary

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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.

Detailed Description

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Conditions

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Women Diagnosed With Infertility

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

First, the intervention group was created in the study and the study was completed, then the control group was studied. 5 interviews were conducted with the women in the intervention group and the average time between the first and last interviews was 15.03±1.59 weeks. 2 interviews were conducted with the women included in the control group and the time between these interviews was 1.41±0.53 weeks.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Mediterranean diet

Mediterranean diet was applied to this group according to the needs of the individuals. The explanation was made through the Mediterranean diet training document and sample menu prepared by the researcher. The individuals were asked to apply this diet for 12 weeks. The individuals' compliance with the diet was evaluated with food consumption records in 4-week periods. Blood samples were taken from the individuals at the beginning of the treatment as biological material and at the end, blood samples and follicle fluid samples were collected according to the adjuvant treatment. Fatty acid analyses were performed with gas chromatography.

Group Type OTHER

Mediterranean diet

Intervention Type 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.

Control group

This group did not receive any intervention. Food consumption records, blood samples and follicular fluid samples were taken only once from individuals who came for IVF treatment.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mediterranean diet

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Gazi University

OTHER

Sponsor Role collaborator

Trakya University

OTHER

Sponsor Role lead

Responsible Party

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Özge CEMALİ

Res. Ass. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Gazi University

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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47/2020-06

Identifier Type: -

Identifier Source: org_study_id

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