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

August 14, 2024 updated by: Özge CEMALİ, Trakya University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey
        • Gazi University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: 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.
Other: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
through study completion, an average of 1 year
second meeting
Time Frame: through study completion, an average of 1 year
An explanation of the individual Mediterranean diet
through study completion, an average of 1 year
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
through study completion, an average of 1 year
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
through study completion, an average of 1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Trakya University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Gazi University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 2, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 9, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 19, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 19, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 47/2020-06

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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