Evaluation of the Effect of Dietary PI and TAC on the Outcome of Pregnancy in in Vitro Fertilization Treatment

February 24, 2025 updated by: Nagihan Kırcali Haznedar, Hacettepe University

Evaluation of the Effect of Dietary Phytochemical Index and Antioxidant Capacity on the Outcome of Ongoing Pregnancy in in Vitro Fertilization Treatment

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)

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

280

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
    • Altındag
      • Ankara, Altındag, Turkey, 06100
        • Hacettepe

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

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ongoing pregnancy
Time Frame: 1 year
"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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical pregnancy
Time Frame: 1 year
"Clinical pregnancy" is a term used in reproductive medicine to describe a pregnancy in which there is evidence of a gestational sac or fetal heartbeat on ultrasound examination. Clinical pregnancy is typically confirmed around 6-7 weeks of gestation and is a significant milestone in assisted reproductive technology (ART) cycles. The clinical pregnancy rate is often used as an outcome measure to assess the success of ART procedures.
1 year

Collaborators and Investigators

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

Sponsor

Hacettepe 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)

February 15, 2021

Primary Completion (Actual)

February 15, 2024

Study Completion (Actual)

April 15, 2024

Study Registration Dates

First Submitted

May 17, 2023

First Submitted That Met QC Criteria

May 26, 2023

First Posted (Actual)

May 31, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 24, 2025

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 222S315

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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