Infertility, Sterility, Reproductive, Reproductive Sterility, Sterility, Subfertility, Sub-FertilityFAIR-HUNCT06795568
Complex Fertility Awareness Study - Hungary
An observational study of Infertility, Sterility, Reproductive, Reproductive Sterility, Sterility, Subfertility, Sub-Fertility, run by University of Pecs.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Infertility, Sterility, Reproductive, Reproductive Sterility, Sterility, Subfertility, Sub-Fertility
- How many people
- 750 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2025to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
Who cannot join
- Participants diagnosed with any mental disorders and significant physical or mobility impairments will be excluded.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Examination of Fertility Awareness with an Integrative Approach: a Mixed-method Multi-centre Research Study
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.
Read the 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
- Keywords
- Fertility; integrative approach; infertility; assisted reproductive techniques, IVF; health behaviour; physical activity; dietary
- Medical subject headings
- Infertility, Motor Activity
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 month
Primary outcome of the MART - Live birth
Live birth with a gestational age of ≥ 20 weeks, reflecting the World Health Organization definition.
Measured: 18 month
Secondary outcomes (11)
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.
Measured: 18 month
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.
Measured: 18 month
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).
Measured: 18 month
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).
Measured: 18 month
Quality of Life (FertiQoL and WHOQoL-BREF)
The Fertility-Related Quality of Life Questionnaire (FertiQoL) is a comprehensive tool designed to measure the impact of fertility problems on quality of life. Developed by Boivin et al. (2011) in collaboration with the World Health Organization, it evaluates four core domains: emotional, mind-body, relational, and social. It also includes optional treatment and core modules. The FertiQoL is extensively validated and widely used in fertility research, providing insights into the psychosocial challenges of individuals or couples undergoing infertility treatment. Its multidimensional approach ensures that various aspects of quality of life specific to infertility are captured.
The WHOQoL-BREF, developed by the World Health Organization, is a shortened version of the WHOQoL-100. It evaluates quality of life across four key domains: physical health, psychological health, social relationships, and environment. This 26-item questionnaire is validat
Measured: 18 month
Self-reported physical activity and sleep (GPAQ, PAHCO-12 and AIS)
The 24h HMB combines PA and sleep. The Global Physical Activity Questionnaire (GPAQ), developed by the World Health Organization (WHO), is a widely used tool for assessing physical activity in different domains: work, transportation, and leisure time. It captures information about intensity, duration, and frequency of physical activity, as well as sedentary behavior (Armstrong \& Bull, 2006).
The Physical Activity-Related Health Competence (PAHCO-12) is a concise instrument for assessing an individual's competence in health-related physical activity. It evaluates three core dimensions: knowledge about physical activity and its health effects, self-regulation abilities, and intrinsic The Athens Insomnia Scale (AIS) assess insomnia based on ICD-10 criteria. It measures sleep difficulty through eight items covering aspects such as sleep induction, awakenings, sleep duration, and overall quality.
Measured: 18 month
Patient Self-Tracking on PA and energy balance
Examining PA and energy balance on ways that patients will engage with self-tracking activities using mobile apps and ActiGraphGT3Xbt and CareSense CGM.
Measured: 18 month
Complementary medicine (I-CAM-Q)
Complementary Medicine refers to health practices and treatments that are used alongside conventional medical treatments. It includes a broad range of practices, such as acupuncture, herbal medicine, chiropractic care, and others, which aim to improve health and well-being (Ernst, 2005). The I-CAM-Q (International Complementary and Alternative Medicine Questionnaire) is a tool designed to assess individuals' use and attitudes toward complementary and alternative medicine (CAM). It helps in gathering data about CAM use across different populations, offering insights into its prevalence, effectiveness, and integration with conventional care (Cummings \& Finnegan, 2017).
Measured: 18 month
Nutritional Supplements in IVF
Self-report on nutritional supplements taken
Measured: 18 month
Health Attitudes and Health Literacy (SHTE and BRIEF)
The Short Health and Treatment Evaluation (SHTE) is a concise questionnaire designed to assess attitudes toward health and treatment. It evaluates individuals' beliefs, perceptions, and readiness to engage in health-related behaviors or interventions. The SHTE is often used in healthcare settings to better understand patient perspectives and improve adherence to treatments.
The Brief Health Literacy Screening Tool (BRIEF) is a short, validated questionnaire that measures an individual's ability to understand, access, and use health information. It includes simple, direct questions about confidence in filling out medical forms, understanding health information, and seeking help when needed. The BRIEF is widely used for quick assessment in clinical and public health research to identify individuals who may require additional support (Sørensen, K., et al. 2012).
Measured: 18 month
Secondary outcome of the MART - Live birth
Number of oocytes, embryos, chemical pregnancy, clinical pregnancy
Measured: 18 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start15 Feb 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, Sterility, Reproductive, Reproductive Sterility, Sterility, Subfertility, Sub-FertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pecs
- Sponsor type
- University, hospital or other
- Collaborators
- University of Debrecen, Dunamenti REK Reproduction Center
- Responsible party
- Principal investigator, Prémusz Viktória, University of Pecs
- Investigators
- Viktória Prémusz, PhD, Principal investigator, University of PecsÁkos Várnagy, PhD, Study director, University of Pecs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06795568
- Sponsor's protocol ID
- BM/30545- 3 /2023
- Other IDs
- NKFI FK-147404
- Acronym
- FAIR-HU
- Status last verified
- Jan 2025
- First submitted
- 21 Jan 2025
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of Fertility Awareness with an Integrative Approach: a Mixed-method Multi-centre Research Study
- ClinicalTrials.gov ID
- NCT06795568
- Acronym / sponsor ID
- FAIR-HU / BM/30545- 3 /2023
- Conditions
- Infertility, Sterility, Reproductive, Reproductive Sterility, Sterility, Subfertility, Sub-Fertility
- Keywords
- Fertility; integrative approach; infertility; assisted reproductive techniques, IVF; health behaviour; physical activity; dietary
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- University of PecsUniversity, hospital or other
- Collaborators
- University of Debrecen, Dunamenti REK Reproduction Center
- Study start
- 15 Feb 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 28 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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/)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Participants diagnosed with any mental disorders and significant physical or mobility impairments will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Level of Fertility Awareness
Time frame: 18 month
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
Time frame: 18 month
Live birth with a gestational age of ≥ 20 weeks, reflecting the World Health Organization definition.
11 secondary outcomes
Fertility-Related Stress and Coping (COMPI FPSS & CSS)
Time frame: 18 month
Screening of Emotional Maladjustment (SCREENIVF)
Time frame: 18 month
Sexual Life (Fertility Problem Inventory - Sexual Concerns Subscale, FPI-S)
Time frame: 18 month
Mental Health (BDI-9 H and GHQ-12)
Time frame: 18 month
Quality of Life (FertiQoL and WHOQoL-BREF)
Time frame: 18 month
Self-reported physical activity and sleep (GPAQ, PAHCO-12 and AIS)
Time frame: 18 month
Patient Self-Tracking on PA and energy balance
Time frame: 18 month
Complementary medicine (I-CAM-Q)
Time frame: 18 month
Nutritional Supplements in IVF
Time frame: 18 month
Health Attitudes and Health Literacy (SHTE and BRIEF)
Time frame: 18 month
Secondary outcome of the MART - Live birth
Time frame: 18 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
- Cross-cultural adaptation and validation of the Global Physical Activity Questionnaire among healthy Hungarian adults.Link provided by the sponsor.
- Oxidative stress in relation to diet and physical activity among premenopausal womenLink provided by the sponsor.
- Validity of the Global Physical Activity Questionnaire (GPAQ) in assessing levels and change in moderate-vigorous physical activity and sedentary behaviourLink provided by the sponsor.
- 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 womenLink provided by the sponsor.
- G\*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciencesLink provided by the sponsor.
- Holistic physical exercise training improves physical literacy among physically inactive adults: a pilot intervention studyLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Infertility, Sterility, Reproductive, Reproductive Sterility, Sterility, Subfertility, Sub-Fertility
Recruiting
A Novel Integrative Non-invasive Embryo Selection Approach for IVF Based on MK-RS Analysis
Reproductive Issues, Subfertility
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Viktória Prémusz, PhD principal investigator
University of Pecs
Ákos Várnagy, PhD study director
University of Pecs
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, Sterility, Reproductive, Reproductive Sterility, Sterility, Subfertility, Sub-Fertility, run by University of Pecs.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Viktória Prémusz, PhD (+3672501500, premusz.viktoria@pte.hu; fair-hu@pte.hu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of Fertility Awareness (time frame: 18 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2025.