Clinical trial NCT05882422: Evaluation of the Effect of Dietary PI and TAC on the Outcome of Pregnancy in In Vitro Fertilization Treatment
Official title: Evaluation of the Effect of Dietary Phytochemical Index and Antioxidant Capacity on the Outcome of Ongoing Pregnancy in In Vitro Fertilization Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ongoing Pregnancy
In-vitro Fertilization
Keywords: Phytochemicals
Polyphenols
Dietary İnflammatory Index
In-vitro fertilization
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2023-05-31
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Maximum age (years): 51
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Couples who apply to the IVF unit and meet the following criteria will be included.

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)


Eligibility criteria: 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

Primary outcomes:
measure: Ongoing pregnancy
timeFrame: 1 year
Secondary outcomes:
measure: Clinical pregnancy
timeFrame: 1 year
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe
state: Altındag
Study officials:
References: