Clinical trial NCT06559904: The Effect of the Mediterranean Diet on Fatty Acids in Biological Fluids of Women Undergoing Infertility Treatment
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Women Diagnosed With Infertility
Keywords: Fatty acids, Folicular Fluid, Implantation, Infertility, Mediterranean Diet, Ratio of ω6/ω3fatty acid
Lead sponsor: Trakya University
Sponsor class: OTHER
Collaborators: name: Gazi University
First posted: 2024-08-19
Enrollment: 32
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: first meeting
timeFrame: through study completion, an average of 1 year
measure: second meeting
timeFrame: through study completion, an average of 1 year
measure: third and forth meeting
timeFrame: through study completion, an average of 1 year
measure: fifth meeting
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: analysis of blood and follicular fluid samples
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University
Study officials:
References: