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NCT Number: NCT05882422

Evaluation of the Effect of Dietary PI and TAC on the Outcome of 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)

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Key information

Age range

18 year–51 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hacettepe

Ankara, Altındag, 06100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
May 31, 2023
Registry last updated
Feb 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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