About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Participants diagnosed with any mental disorders and significant physical or mobility impairments will be excluded.
Trial 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.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
Primary outcome of the MART - Live birth
Live birth with a gestational age of ≥ 20 weeks, reflecting the World Health Organization definition.
Secondary outcomes
Fertility-Related Stress and Coping (COMPI FPSS & CSS)
The Copenhagen Multi-Centre Psychosocial Infertility Study (COMPI) Fertility Problem Stress Scale (FPSS) and Coping Strategy Scale (CSS) are widely used to measure infertility-related stress and coping mechanisms. The FPSS assesses stress across domains like personal, social, and partner-related dimensions, while the CSS evaluates strategies such as active avoidance, seeking support, or problem-solving. These tools have been extensively validated in diverse populations (Schmidt et al., 2003; 2005), providing insights into the psychological burden of infertility and coping efficacy.
Screening of Emotional Maladjustment (SCREENIVF)
SCREENIVF is a screening tool designed to identify emotional maladjustment in individuals undergoing fertility treatment. It assesses dimensions such as anxiety, depression, and perceived control, offering a quick yet reliable way to detect individuals at risk of emotional distress. Its development (Verhaak et al., 2010) ensures its applicability in fertility care settings, promoting early interventions to support mental health.
Sexual Life (Fertility Problem Inventory - Sexual Concerns Subscale, FPI-S)
The Fertility Problem Inventory (FPI) is a multidimensional measure of the psychosocial impact of infertility, with the Sexual Concerns Subscale (FPI-S) specifically focusing on how infertility affects sexual life. This subscale addresses issues such as sexual satisfaction, intimacy, and the emotional toll of fertility challenges on sexual relationships (Newton et al., 1999).
Mental Health (BDI-9 H and GHQ-12)
The Beck Depression Inventory - Short Form (BDI-9 H) is a shortened version of the BDI, designed to measure depressive symptoms in clinical and non-clinical populations (Beck et al., 1961; Beck \& Steer, 1984). It is widely used in studies involving individuals experiencing fertility-related distress. The General Health Questionnaire (GHQ-12) is a brief, reliable tool to screen for general mental health issues, including anxiety and depression. Its adaptability and ease of use make it suitable for assessing overall psychological well-being in fertility-related contexts (Goldberg \& Williams, 1988).
Locations
Sponsors and contacts
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University of Pecs
Lead sponsor
University of Debrecen
Collaborator
Dunamenti REK Reproduction Center
Collaborator
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