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

In-vitro Fertilization Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05882422
• Other study ID #: 222S315
• Status: Enrolling by invitation
• Start date: February 15, 2023
• Est. completion date: April 15, 2024

Study information

• Verified date: May 2023
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 280
• Est. completion date: April 15, 2024
• Est. primary completion date: February 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 51 Years

Eligibility

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

Related Conditions & MeSH terms

• In-vitro Fertilization
• Ongoing Pregnancy

Locations

Country	Name	City	State
Turkey	Hacettepe	Ankara	Altindag

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Clinical pregnancy	"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