Complex Fertility Awareness Study - Hungary

NCT06795568 | Not Yet Recruiting DMC

• 2 other identifiers: BM/30545- 3 /2023NKFI FK-147404
• Study Type: observational
• Target: 750
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

Fertility; integrative approach; infertility; assisted reproductive techniques, IVF; health behaviour; physical activity; dietary

Outcome Measures

Primary Outcomes (2)

• Level of Fertility Awareness

  The level of fertility awareness measured by Fertility Awareness Survey (FAS and FAS-M) questionnaire. The Hungarian version of the Fertility Awareness Survey (FAS) will be used to evaluate knowledge and attitudes regarding assisted reproductive technologies (ART). Originally developed by Daniluk et al., the FAS includes separate knowledge sections for women and men. The questionnaire has three sections: self-assessed knowledge and attitudes toward ART, factual knowledge about general fertility, and ART-related knowledge. Participants will indicate their knowledge and attitudes, and respond to statements about fertility and ART.

  18 month

• Primary outcome of the MART - Live birth

  Live birth with a gestational age of ≥ 20 weeks, reflecting the World Health Organization definition.

  18 month

Secondary Outcomes (11)

• Fertility-Related Stress and Coping (COMPI FPSS & CSS)

  18 month

• Screening of Emotional Maladjustment (SCREENIVF)

  18 month

• Sexual Life (Fertility Problem Inventory - Sexual Concerns Subscale, FPI-S)

  18 month

• Mental Health (BDI-9 H and GHQ-12)

  18 month

• Quality of Life (FertiQoL and WHOQoL-BREF)

  18 month

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Pecs: lead
• University of Debrecen: collaborator
• Dunamenti REK Reproduction Center: collaborator

Related Links

• Cross-cultural adaptation and validation of the Global Physical Activity Questionnaire among healthy Hungarian adults.
• Oxidative stress in relation to diet and physical activity among premenopausal women
• Validity of the Global Physical Activity Questionnaire (GPAQ) in assessing levels and change in moderate-vigorous physical activity and sedentary behaviour
• 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
• G\*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences
• Holistic physical exercise training improves physical literacy among physically inactive adults: a pilot intervention study
• Párkapcsolati változások, termékenységi trendek. In S. I. Kolosi Tamás, Tóth István György (Ed.)
• National, regional, and global trends in infertility prevalence since 1990
• Plasma, urinary, and salivary 8-epi-prostaglandin f2alpha levels in normotensive and preeclamptic pregnancies
• Energy expenditure and plasma F2-isoprostanes across the menstrual cycle
• Psychometric characteristics of the FertiQoL questionnaire in a German sample of infertile individuals and couples
• Cross-cultural comparison of fertility specific quality of life in German, Hungarian and Jordanian couples attending a fertility center
• Detection of physical activity types using triaxial accelerometers

MeSH Terms

Conditions

Infertility; Motor Activity

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Behavior

Study Officials

• Viktória Prémusz, PhD

  University of Pecs

  PRINCIPAL INVESTIGATOR

• Ákos Várnagy, PhD

  University of Pecs

  STUDY DIRECTOR

Central Study Contacts

Viktória Prémusz, PhD

CONTACT

+3672501500; premusz.viktoria@pte.hu; fair-hu@pte.hu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. PRÉMUSZ Viktória Ph.D

Study Record Dates

• First Submitted: January 21, 2025
• First Posted: January 28, 2025
• Study Start: February 15, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 28, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share