AzTrials
AzTrials

Infertility, FemaleNCT07308561

The Relationship Between Quality of Life, Anxiety Levels, and Attitudes Toward Artificial Intelligence Among Women Undergoing Infertility Treatment

An observational study of Infertility, Female and Artificial Intelligence, run by Acibadem University at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 45 years, women only
How many people
191 participants
Where
1 siteTurkey (Türkiye)
Study dates
23 Oct 2025to 23 Oct 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
  • Women only
  • No healthy volunteers
  • Adult

Study population: Women aged 18-45 years diagnosed with primary or secondary infertility and currently undergoing infertility treatment (IUI, IVF, or ICSI).

Who may be able to join

  • 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.

Who cannot join

  • Women with diagnosed psychological disorders (e.g., clinical depression, anxiety disorders).
  • Women who are not undergoing infertility treatment.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Güzin Ünlü Suvari, M.Sc. contact

+902165004429

guzin.unlu@acibadem.edu.tr

Turkey (Türkiye)1 site, 1 recruiting

  • Acıbadem Health Group

    Istanbul, Ataşehir

    Güzin Ünlü Suvari, Ph.D. (C), +90 ext. 2165004429, guzinnunlu@gmail.com

    Merve Coşkun, Ph.D.

    Recruiting

Other trials in Turkey (Türkiye)

About this study

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.

Medical subject headings
Infertility, Female, Anxiety Disorders

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sociodemographic and Descriptive Information Form

    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.

    Measured: At baseline (one-time assessment at enrollment)

  2. State-Trait Anxiety Inventory (STAI) - Trait Anxiety Scale

    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.

    Measured: At baseline (one-time assessment at enrollment)

  3. General Attitudes Toward Artificial Intelligence Scale

    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.

    Measured: At baseline (one-time assessment at enrollment)

  4. Fertility Quality of Life Scale (FertiQol) - Core Module

    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.

    Measured: At baseline (one-time assessment at enrollment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Dec 2025
  2. Study start23 Oct 2025
  3. Primary completion23 Oct 2026 (estimated)
  4. Study completion23 Oct 2026 (estimated)

Resources

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
Other
Time perspective
Prospective
Enrolment
191 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07308561
Sponsor's protocol ID
2025-15/591
Status last verified
Dec 2025
First submitted
17 Dec 2025
Last updated
29 Dec 2025
Results posted
No
FDA-regulated drug
No
Individual data sharing
No: 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.

Publications

  • 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.

    PubMed 40944797

  • 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.

    PubMed 33717249

  • 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.

    PubMed 33894750

  • 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.

    PubMed 26345684

  • 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.

    PubMed 39776390

  • 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.

    PubMed 36552986

  • 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.

    PubMed 40736784

  • 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.

    PubMed 30612477

  • 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.

    PubMed 38224730

  • 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.

    PubMed 34235291

Questions about this trial

What is this clinical trial studying?

An observational study of Infertility, Female and Artificial Intelligence, run by Acibadem University at 1 site in Turkey (Türkiye).

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 4 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

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 Güzin Ünlü Suvari, M.Sc. (+902165004429, guzin.unlu@acibadem.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sociodemographic and Descriptive Information Form (time frame: At baseline (one-time assessment at enrollment)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07308561, which also lists 16 linked publications.

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 29 Dec 2025.

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