Clinical trial NCT06795568: Complex Fertility Awareness Study - Hungary
Official title: Examination of Fertility Awareness with an Integrative Approach: a Mixed-method Multi-centre Research Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Infertility, Sterility, Reproductive, Reproductive Sterility, Sterility, Subfertility, Sub-Fertility
Keywords: Fertility; integrative approach; infertility; assisted reproductive techniques, IVF; health behaviour; physical activity; dietary
Lead sponsor: University of Pecs
Sponsor class: OTHER
Collaborators: name: University of Debrecen
name: Dunamenti REK Reproduction Center
First posted: 2025-01-28
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All female patients with both female and male factors of infertility who were indicated for fertility treatment (IVF/ICSI) will be randomly enrolled to participate in the study. Spouses will be enrolled based on the above invitation.

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/)

Eligibility criteria: Inclusion Criteria:

* Inclusion criteria will be BMI ≥ 18 kg/m2 and ≤ 38 kg/m2, 18 to 45 years of age, having undergone not more than three unsuccessful cycles and no significant health risk relevant to the ART procedure and outcome (metabolic and vascular diseases including diabetes mellitus, metabolic syndrome, fatty liver diseases and atherosclerosis

Exclusion Criteria:

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

Primary outcomes:
measure: Level of Fertility Awareness
timeFrame: 18 month
measure: Primary outcome of the MART - Live birth
timeFrame: 18 month
Secondary outcomes:
measure: Fertility-Related Stress and Coping (COMPI FPSS & CSS)
timeFrame: 18 month
measure: Screening of Emotional Maladjustment (SCREENIVF)
timeFrame: 18 month
measure: Sexual Life (Fertility Problem Inventory - Sexual Concerns Subscale, FPI-S)
timeFrame: 18 month
measure: Mental Health (BDI-9 H and GHQ-12)
timeFrame: 18 month
measure: Quality of Life (FertiQoL and WHOQoL-BREF)
timeFrame: 18 month
measure: Self-reported physical activity and sleep (GPAQ, PAHCO-12 and AIS)
timeFrame: 18 month
measure: Patient Self-Tracking on PA and energy balance
timeFrame: 18 month
measure: Complementary medicine (I-CAM-Q)
timeFrame: 18 month
measure: Nutritional Supplements in IVF
timeFrame: 18 month
measure: Health Attitudes and Health Literacy (SHTE and BRIEF)
timeFrame: 18 month
measure: Secondary outcome of the MART - Live birth
timeFrame: 18 month
Other outcomes:
Locations:
Study officials:
affiliation: University of Pecs
name: Viktória Prémusz, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pecs
name: Ákos Várnagy, PhD
role: STUDY_DIRECTOR
References: