- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07308561
The Relationship Between Quality of Life, Anxiety Levels, and Attitudes Toward Artificial Intelligence Among Women Undergoing Infertility Treatment
December 17, 2025 updated by: Güzin Ünlü Suvari, Acibadem University
Infertility affects approximately one in six individuals worldwide and is associated with significant psychological distress, particularly among women undergoing treatment.
Increased anxiety levels are strongly linked to reduced quality of life during the infertility process.
With the growing integration of artificial intelligence (AI) into healthcare, AI-based tools are increasingly used in infertility care to support decision-making and patient engagement.
While many patients are familiar with AI technologies, individual attitudes toward AI may influence their acceptance and potential psychosocial benefits.
This study aims to examine the relationship between attitudes toward artificial intelligence, anxiety levels, and quality of life among women undergoing infertility treatment.
Study Overview
Status
Recruiting
Study Type
Observational
Enrollment (Estimated)
191
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Güzin Ünlü Suvari, M.Sc.
- Phone Number: +902165004429
- Email: guzin.unlu@acibadem.edu.tr
Study Locations
-
-
Ataşehir
-
Istanbul, Ataşehir, Turkey (Türkiye)
- Recruiting
- Acıbadem Health Group
-
Contact:
- Güzin Ünlü Suvari, Ph.D. (C)
- Phone Number: 2165004429 +90
- Email: guzinnunlu@gmail.com
-
Principal Investigator:
- Merve Coşkun, Ph.D.
-
Principal Investigator:
- Ergül Aslan, Prof.
-
Principal Investigator:
- Hale Göksever Çelik, Prof. Dr.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Women aged 18-45 years diagnosed with primary or secondary infertility and currently undergoing infertility treatment (IUI, IVF, or ICSI).
Description
Inclusion Criteria:
- Women aged 18-45 years diagnosed with infertility (primary or secondary infertility).
- Women undergoing infertility treatment and those who have experienced various treatment modalities (IUI, IVF, ICSI).
- Women who voluntarily agree to participate in the study.
- Women who are able to understand and speak Turkish.
Exclusion Criteria:
- Women with diagnosed psychological disorders (e.g., clinical depression, anxiety disorders).
- Women who are not undergoing infertility treatment.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sociodemographic and Descriptive Information Form
Time Frame: At baseline (one-time assessment at enrollment)
|
This form includes 30 items designed to collect data on participants' sociodemographic characteristics, general health status, obstetric and gynecological history, and use of technology and artificial intelligence.
It provides a comprehensive background profile of women undergoing infertility treatment.
|
At baseline (one-time assessment at enrollment)
|
|
State-Trait Anxiety Inventory (STAI) - Trait Anxiety Scale
Time Frame: At baseline (one-time assessment at enrollment)
|
The Trait Anxiety Scale is used to assess individuals' general and persistent anxiety levels.
The scale consists of multiple items rated on a Likert-type format, with total scores ranging from 20 to 80. Higher scores indicate higher levels of anxiety.
|
At baseline (one-time assessment at enrollment)
|
|
General Attitudes Toward Artificial Intelligence Scale
Time Frame: At baseline (one-time assessment at enrollment)
|
This scale assesses individuals' positive and negative attitudes toward artificial intelligence using a 5-point Likert-type format.
It consists of 20 items, with negatively worded items reverse-coded.
Higher total scores reflect more positive attitudes toward artificial intelligence.
|
At baseline (one-time assessment at enrollment)
|
|
Fertility Quality of Life Scale (FertiQol) - Core Module
Time Frame: At baseline (one-time assessment at enrollment)
|
The Fertility Quality of Life Scale evaluates quality of life in individuals experiencing fertility problems.
The core module assesses emotional, mind-body, relational, and social dimensions of quality of life using a Likert-type response format.
Higher scores indicate better quality of life.
|
At baseline (one-time assessment at enrollment)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Gameiro S, Boivin J, Dancet E, de Klerk C, Emery M, Lewis-Jones C, Thorn P, Van den Broeck U, Venetis C, Verhaak CM, Wischmann T, Vermeulen N. ESHRE guideline: routine psychosocial care in infertility and medically assisted reproduction-a guide for fertility staff. Hum Reprod. 2015 Nov;30(11):2476-85. doi: 10.1093/humrep/dev177. Epub 2015 Sep 7.
- Braverman AM, Davoudian T, Levin IK, Bocage A, Wodoslawsky S. Depression, anxiety, quality of life, and infertility: a global lens on the last decade of research. Fertil Steril. 2024 Mar;121(3):379-383. doi: 10.1016/j.fertnstert.2024.01.013. Epub 2024 Jan 13.
- European Society of Human Reproduction and Embryology (ESHRE). (2024, April). Factsheet on infertility - prevalence, treatment and fertility decline in Europe. ESHRE. https://www.eshre.eu
- Shi Z, Zheng Y, Zhu X, Mao Z, Nie H, Chen G, Li S. Understanding health-related quality of life in Chinese infertility patients: a qualitative study. Qual Life Res. 2025 Nov;34(11):3105-3119. doi: 10.1007/s11136-025-04066-y. Epub 2025 Sep 13.
- Simionescu G, Doroftei B, Maftei R, Obreja BE, Anton E, Grab D, Ilea C, Anton C. The complex relationship between infertility and psychological distress (Review). Exp Ther Med. 2021 Apr;21(4):306. doi: 10.3892/etm.2021.9737. Epub 2021 Feb 1.
- Song D, Li X, Yang M, Wang N, Zhao Y, Diao S, Zhang X, Gou X, Zhu X. Fertility quality of life (FertiQoL) among Chinese women undergoing frozen embryo transfer. BMC Womens Health. 2021 Apr 24;21(1):177. doi: 10.1186/s12905-021-01325-1.
- Cromack SC, Lew AM, Bazzetta SE, Xu S, Walter JR. The perception of artificial intelligence and infertility care among patients undergoing fertility treatment. J Assist Reprod Genet. 2025 Mar;42(3):855-863. doi: 10.1007/s10815-024-03382-5. Epub 2025 Jan 7.
- Medenica S, Zivanovic D, Batkoska L, Marinelli S, Basile G, Perino A, Cucinella G, Gullo G, Zaami S. The Future Is Coming: Artificial Intelligence in the Treatment of Infertility Could Improve Assisted Reproduction Outcomes-The Value of Regulatory Frameworks. Diagnostics (Basel). 2022 Nov 28;12(12):2979. doi: 10.3390/diagnostics12122979.
- Sarshoori, A. A., Mostafavi, M., Heidarpoor, S., & Chekeni, A. M. (2024). Role of Artificial Intelligence in Infertility Screening and Treatment: A Systematic Review. Iranian Biomedical Journal, 28, 253.
- Lee, C., Chae, H. J., Kim, H. M., Lee, H., Choi, S., & Min, H. S. (2024). Enhancing infertility care with a ChatGPT-based chatbot: integrating clinical and community insights for improved patient support. Fertility and Sterility, 122(4), e141-e142.
- Méndez-Suárez, M., Delbello, L., de Vega de Unceta, A., & Ortega Larrea, A. L. (2024). Factors affecting consumers' attitudes towards artificial intelligence. Journal of Promotion Management, 30(7), 1141-1158.
- Mendizabal-Ruiz G, Paredes O, Borrayo E, Chavez-Badiola A. FERTILITY CARE IN LOW- AND MIDDLE- INCOME COUNTRIES: The future use of AI to improve accessibility of assisted reproductive technology in low- and middle-income countries. Reprod Fertil. 2025 Aug 14;6(3):e240077. doi: 10.1530/RAF-24-0077. Print 2025 Jul 1.
- Massarotti C, Gentile G, Ferreccio C, Scaruffi P, Remorgida V, Anserini P. Impact of infertility and infertility treatments on quality of life and levels of anxiety and depression in women undergoing in vitro fertilization. Gynecol Endocrinol. 2019 Jun;35(6):485-489. doi: 10.1080/09513590.2018.1540575. Epub 2019 Jan 7.
- Kaya, F., Aydin, F., Schepman, A., Rodway, P., Yetişensoy, O., & Demir Kaya, M. (2022). The roles of personality traits, AI anxiety, and demographic factors in attitudes towards artificial intelligence. International Journal of Human-Computer Interaction. https://doi.org/10.1080/10447318.2022.2151730
- Schepman A, Rodway P. Initial validation of the general attitudes towards Artificial Intelligence Scale. Comput Hum Behav Rep. 2020 Jan-Jul;1:100014. doi: 10.1016/j.chbr.2020.100014. Epub 2020 May 18.
- Schepman, A. & Rodway, P. (2022). The General Attitudes towards Artificial Intelligence Scale (GAAIS): Confirmatory Validation and Associations with Personality, Corporate Distrust, and General Trust. International Journal of Human-Computer Interaction https://doi.org/10.1080/10447318.2022.2085400
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 23, 2025
Primary Completion (Estimated)
October 23, 2026
Study Completion (Estimated)
October 23, 2026
Study Registration Dates
First Submitted
December 17, 2025
First Submitted That Met QC Criteria
December 17, 2025
First Posted (Actual)
December 29, 2025
Study Record Updates
Last Update Posted (Actual)
December 29, 2025
Last Update Submitted That Met QC Criteria
December 17, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025-15/591
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Individual participant data (IPD) will not be publicly shared due to privacy concerns and the sensitive nature of maternal and infant health information.
However, anonymized data may be made available upon reasonable request to the corresponding author after publication of the study results.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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