Complex Fertility Awareness Study - Hungary

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-45
SponsorUniversity of Pecs

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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.

Time frame
18 month
2

Primary outcome of the MART - Live birth

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

Time frame
18 month

Secondary outcomes

1

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.

Time frame
18 month
2

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.

Time frame
18 month
3

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).

Time frame
18 month
4

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).

Time frame
18 month

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Pecs

Lead sponsor

University of Debrecen

Collaborator

Dunamenti REK Reproduction Center

Collaborator

This trial is not recruiting at the moment. You can still explore other options: