Complex Fertility Awareness Study - Hungary

NCT ID: NCT06795568

Last Updated: 2025-01-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 750 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-02-15
• Study Completion Date: 2026-12-31

Brief Summary

The goal of this observational study is to investigate integrative fertility awareness and its impact on assisted reproductive techniques (ART) in Hungary. It analyzes fertility awareness, health-movement behavior, physical literacy, dietary patterns, psycho-social distress, socio-demographic parameters, and stress biomarkers across four fertility centers. The study employs a mixed-method approach. The research aims to review and analyze the factors of integrative fertility awareness on the course and outcome measures of assisted reproductive techniques (ART) at different fertility centers in Hungary in a mixed-method study.

Detailed Description

Introduction:

The United Nations warns that global demographic trends indicate the world's population is projected to reach 9.7 billion by 2050 and 11 billion by the end of the 21st century. While some countries experience population decline, many are transitioning to an aging population due to longer life expectancy, delayed childbearing, and declining fertility rates. In Hungary, the population has been declining since 1981, with live births remaining below pre-2008 crisis levels. In 2020, there were only 92,000 live births, a 52% decrease compared to 1975.

Hungary's lower birth rate is attributed to infertility, and approximately 10-15% of couples face fertility problems. The World Health Organization (WHO) reports a 12-15% incidence of fertility disorders, with secondary infertility prevalence at 18.0% in Central and Eastern Europe. Due to this in-vitro fertilization (IVF), has increased. Factors affecting IVF outcomes include age, sperm quality, embryo quality, and endometrial thickness. Public policies provide freely available examinations and medicines, emphasizing integrative analysis and add-on treatments to enhance success rates and participant experience. However, no research currently analyzes health behaviors related to reproductive treatments from a fertility awareness perspective.

Significance of Study:

This study is important because previous studies emphasize variations in infertility outcomes related to recreational physical activity (PA). However, the ideal PA metrics (weekly minutes) are not yet defined, and comprehensive investigations considering sleep and awareness are scarce. Hungarian researchers concentrate on psychosocial aspects in infertile couples but have not incorporated lifestyle assessments. Their innovative concept of integrative fertility awareness distinguishes their work globally.

This study will be done in four different centers including; (1) Assisted Reproduction Unit, Department of Obstetrics and Gynaecology, University of Pécs, National Laboratory on Human Reproduction, (2) University of Debrecen, Clinical Center (DEKK), Health Service Units, Center for Assisted Reproduction, (3) Róbert Károly Infertility Center, Dunamenti REK Infertility Centre, (4) Buda Infertility Center, Dunamenti REK Infertility Centre.

All female patients with both female and male factors of infertility who were indicated for fertility treatment (IVF/ICSI) and their spouses will be consecutively invited to participate in the study.

Objectives:

Some of the objectives to be answered through this proposal are:

Objective 1: Investigation of fertility awareness (reproductive health literacy, fertility awareness, fertility treatment compliance) of female patients with infertility diagnoses and indicated for fertility treatment (Pre-ART/ART) by socio-demographic parameters, Objective 2: Mapping of physical activity patterns with subjective and objective measurement methods based on the 24h health-movement behavior concept (amount and intensity of physical activity - sedentary behavior - sleep quality and quantity) and physical literacy.

Objective 3: Investigating the relationship between dietary patterns (with special regard to non-prescription supplements and fertility awareness.

Methods:

The study will collect socio-demographic information through questions about age, education level, income, marital status, partnership duration, infertility duration, BMI, and lifestyle habits. For the assessment of physical activity (PA), sedentary behavior, and sleep, participants will self-report their exercise habits using a PA diary and the survey method. Participants' self-reported PA will be compared with objective measures collected using Triaxial ActiGraph GT3X+ accelerometers. These accelerometers, along with ActiLife 6 software, have high sensitivity (over 98%) and specificity (over 99%). Discrepancies between objective and self-reported PA emphasize the need to improve physical literacy among those undergoing assisted reproductive technology (ART) treatment. We plan to assess it using a Physical Literacy Questionnaire.

In additional, the fertility awareness assessment will be done by use of a modified version of the Fertility-Awareness Questionnaire (FAQ). On dietary supplements, the study will investigate dietary patterns and non-prescription supplements based on self-reports from respondents. For, laboratory measures in our study, we'll measure oxidative stress markers using the ELISA method. Energy balance will be exeminde with CGMs.

The statistical analyses will be conducted using IBM SPSS Statistics 27.0 for Mac. Methods include the Kolmogorov-Smirnov test for data distribution, the Mann-Whitney U-test for continuous variables, Spearman's rank correlation for associations, and multivariate linear regression for predicting outcomes. Logistic regression evaluates covariate effects on live births. Posthoc power analysis will use G*Power software. Data will be expressed as mean ± SD and medians with 25th and 75th percentiles, with significance at p˂0.05. The dataset supporting the conclusions of this article will be available from the repository of the University of Pécs (PEA, https://pea.lib.pte.hu/)

Conditions

Infertility, Sterility, Reproductive, Reproductive Sterility, Sterility, Subfertility, Sub-Fertility

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Exclusion Criteria

• Participants diagnosed with any mental disorders and significant physical or mobility impairments will be excluded.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Debrecen

OTHER

Sponsor Role: collaborator

Dunamenti REK Reproduction Center

UNKNOWN

Sponsor Role: collaborator

University of Pecs

OTHER

Sponsor Role: lead

Responsible Party

Prémusz Viktória

Dr. PRÉMUSZ Viktória Ph.D

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Viktória Prémusz, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pecs

Ákos Várnagy, PhD

Role: STUDY_DIRECTOR

University of Pecs

Central Contacts

Viktória Prémusz, PhD

Role: CONTACT

premusz.viktoria@pte.hu; fair-hu@pte.hu

+3672501500

Related Links

http://doi.org/10.1186/s12889-020-08477-z

Cross-cultural adaptation and validation of the Global Physical Activity Questionnaire among healthy Hungarian adults.

http://doi.org/10.1007/s10389-006-0024-x

Oxidative stress in relation to diet and physical activity among premenopausal women

http://doi.org/10.1186/1471-2458-14-1255

Validity of the Global Physical Activity Questionnaire (GPAQ) in assessing levels and change in moderate-vigorous physical activity and sedentary behaviour

http://doi.org/10.1007/s00404-013-2835-7

Effects of gender roles, child wish motives, subjective well-being, and marital adjustment on infertility-related stress: a preliminary study with a Hungarian sample of involuntary childless men and women

http://doi.org/10.3758/bf03193146

G\*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences

http://doi.org/10.1186/s12889-019-6719-z

Holistic physical exercise training improves physical literacy among physically inactive adults: a pilot intervention study

http://tarki.hu/sites/default/files/2020-10/146_170_Kapitany_Murinko_web.pdf

Párkapcsolati változások, termékenységi trendek. In S. I. Kolosi Tamás, Tóth István György (Ed.)

http://doi.org/10.1371/journal.pmed.1001356

National, regional, and global trends in infertility prevalence since 1990

http://doi.org/10.1067/mob.2000.108877

Plasma, urinary, and salivary 8-epi-prostaglandin f2alpha levels in normotensive and preeclamptic pregnancies

http://doi.org/10.1249/MSS.0b013e3181fc5eab

Energy expenditure and plasma F2-isoprostanes across the menstrual cycle

http://doi.org/10.1186/s12955-018-1058-9

Psychometric characteristics of the FertiQoL questionnaire in a German sample of infertile individuals and couples

http://doi.org/10.1186/s12955-016-0429-3

Cross-cultural comparison of fertility specific quality of life in German, Hungarian and Jordanian couples attending a fertility center

http://doi.org/10.1123/jpah.2011-0347

Detection of physical activity types using triaxial accelerometers

Other Identifiers

NKFI FK-147404

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

BM/30545- 3 /2023

Identifier Type: -

Identifier Source: org_study_id