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

Not Applicable

Completed

• Conditions: Women Diagnosed With Infertility
• Interventions: Other: Mediterranean diet

• Registration Number: NCT06559904
• Lead Sponsor: Trakya University

Brief Summary

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

Not available

Study Timeline

• Study Start: 2020-02-01
• Primary Completion: 2022-02-01
• Study Completion: 2023-11-02
• Status Verified: 2024-08
• Study First Submitted: 2024-08-09
• Study First Submitted QC: 2024-08-14
• Last Update Submitted: 2024-08-14
• Study First Posted: 2024-08-19
• Last Update Posted: 2024-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mediterranean diet	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.

Primary Outcome Measures

Name	Time	Method
fifth meeting	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
first meeting	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
third and forth meeting	through study completion, an average of 1 year	recording three-day food intake evaluate adherence to the Mediterranean diet using anthropometric measurements
second meeting	through study completion, an average of 1 year	An explanation of the individual Mediterranean diet

Secondary Outcome Measures

Name	Time	Method
analysis of blood and follicular fluid samples	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.

Trial Locations

Locations (1)

Gazi University; 🇹🇷 Ankara, Turkey