NCT05882422

Brief Summary

The aim of this study is to determine the relationship between dietary total antioxidant capacity, phytochemical index, inflammatory index, dietary polyphenol intake and ongoing pregnancy outcome in couples receiving IVF treatment. In this context, the objectives are: Determining the relationship between diet's antioxidant capacity, phytochemical index, inflammatory index, and dietary polyphenol intake and ongoing pregnancy outcome, Determining the relationship between total serum antioxidant capacity, serum oxidant capacity and CRP levels and ongoing pregnancy outcome, It is the determination of the relationship between body composition and ongoing pregnancy. With this study, it is aimed to obtain reliable data on the effects of diet's antioxidant capacity, phytochemical index and dietary polyphenol intake and inflammatory index on reproductive functions. In this way, it is thought that nutritional recommendations that can be given to patients who will undergo IVF treatment before treatment will be developed. In this study, which is a first in terms of examining many parameters related to diets of women and men, it will be evaluated whether the parameters to be examined are effective in IVF cycles. The aims, objectives and hypotheses the researchers put forward within the scope of the study have not been studied extensively before. If the planned project is carried out successfully, new nutritional approaches will be paved in in-vitro fertilization treatment, and it will be possible to contribute to reducing the financial burden of the treatment. In addition, an important step will be taken to increase the total fertility rate (number of children per woman) within the scope of the 11th Development Plan (2019-2023). It also conforms to the 3rd Sustainable Development Goals, "healthy and quality life" (UNDP Turkey 2018)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
280

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2021

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

May 17, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 31, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2024

Completed
Last Updated

February 26, 2025

Status Verified

November 1, 2024

Enrollment Period

3 years

First QC Date

May 17, 2023

Last Update Submit

February 24, 2025

Conditions

Keywords

PhytochemicalsPolyphenolsDietary İnflammatory IndexIn-vitro fertilization

Outcome Measures

Primary Outcomes (1)

  • Ongoing pregnancy

    "Ongoing pregnancy" is a term used in reproductive medicine to describe a pregnancy that has progressed beyond the early stages and is continuing to develop with a viable fetal heartbeat. Ongoing pregnancy is typically confirmed by ultrasound examination after the gestational age of 12 weeks. In assisted reproductive technology (ART) cycles, ongoing pregnancy rate is an important outcome measure used to assess the success of the procedure, as it reflects the number of pregnancies that have the potential to result in live births.

    1 year

Secondary Outcomes (1)

  • Clinical pregnancy

    1 year

Eligibility Criteria

Age18 Years - 51 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Couples who apply to the IVF unit and meet the following criteria will be included.

You may qualify if:

  • Females \<41 years
  • Males \< 55 years
  • BKI ≤ 32 kg/m2

You may not qualify if:

  • Smoking cigarettes
  • Chronic and inflammatory diseases
  • Dietary changes in last 6 months
  • Using antioxidant supplements
  • Females diagnosed with infertility for anatomical reasons, endometriosis, tubal factor, or low ovarian reserve
  • Males diagnosed with azospermia
  • Couples who have had more than two failed cycles

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe

Ankara, Altındag, 06100, Turkey (Türkiye)

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assisstant

Study Record Dates

First Submitted

May 17, 2023

First Posted

May 31, 2023

Study Start

February 15, 2021

Primary Completion

February 15, 2024

Study Completion

April 15, 2024

Last Updated

February 26, 2025

Record last verified: 2024-11

Locations