A Modular Cloud Platform For Fertility Preservation

NCT07642531 | Not Yet Recruiting

• 1 other identifier: KAD-FR-42
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

The research was designed as a randomized controlled study to determine the effectiveness of a modular cloud-based training platform in increasing awareness of fertility preservation. The study aims to develop a free, modular, cloud-based, sustainable digital platform to increase fertility awareness. The platform will provide basic information on fertility preservation methods in plain language to support informed decisions. Content will be based on European Society of Human Reproduction and Embryology (ESHRE) , International Federation of Gynaecology and Obstetrics (FIGO) and Asian Society of Gynecologic Oncology (ASCO) guidelines. The study targets not only cancer patients but also women requesting fertility preservation for medical or social reasons. In the first stage, the platform will be designed with the ADDIE instructional design model (Analysis, Design, Development, Implementation, Evaluation) and content created per international guidelines. In the second stage, the prototype will be pilot-tested and revised. In the third stage, effectiveness will be tested through a randomized controlled trial. Educational modules will be provided to the intervention group, while the control group will receive brochures. The study will include women aged 18-45 with early-stage gynecological cancer (cervix, ovary, tube, endometrium) at Prof. Dr. Cemil Tascioglu City Hospital, untreated. Participants must have Turkish literacy and internet access. Sample size, calculated with G\*Power, is 140 total (70 per group).

Conditions

Fertility Preservation; Gynecologic Cancers

Keywords

fertility; gynecologic cancer; fertility preservation; mobile application

Outcome Measures

Primary Outcomes (4)

• Awareness rates regarding fertility preservation options among patients in the experimental and control groups

  These data will be obtained through the answers given to the "Awareness status questionnaire for fertility protection".

  Change from beginning of the study and after 3 weeks of after the mobile application is given

• fertility preservation knowledge scores

  The Fertility Health Knowledge Scale was developed to evaluate individuals' level of knowledge about fertility health; The Turkish validity and reliability study of the scale was conducted. In this study, the knowledge level of the participants regarding fertility/fertility preservation will be evaluated based on the knowledge score using the scale in question.

  Change from beginning of the study and after 3 weeks of after the mobile application is given

• fertility preservation attitude scores

  The Attitudes Toward Fertility and Childbearing Scale was developed to evaluate the attitudes of women who have not yet become mothers towards fertility and childbearing. The Turkish validity and reliability study of the scale was conducted. In this study, participants' attitude scores (sub-dimensions and total attitude level) towards fertility and childbearing will be evaluated using the scale in question.

  Change from beginning of the study and after 3 weeks of after the mobile application is given

• Acceptance of fertility preservation

  number of patients undergoing fertility preservation procedures

  Change from beginning of the study and after 3 weeks of after the mobile application is given

Study Arms (2)

Control- Routine information

NO INTERVENTION

The control group will be given an educational brochure with similar features for fertility preservation.

İntervention- Using the educational platform

EXPERIMENTAL

Prof. Dr. Cemil Taşçıoğlu City Hospital will divide female patients of reproductive age (18-45 years) who have been diagnosed with gynecological cancer (early-stage cervical, ovarian, tubal, and endometrial cancer) and have not yet started treatment, and who have been referred for egg/ovarian tissue/embryo freezing, into two groups. The intervention group will use the cloud-based sustainable education platform developed for fertility preservation within the scope of the study. The control group will be given an educational brochure with similar features for fertility preservation.

Other: Developing a Modular Cloud-Based Platform to guide decision-making in fertility preservation

Interventions

Developing a Modular Cloud-Based Platform to guide decision-making in fertility preservation OTHER

In this study, a modular cloud-based platform will be developed to raise awareness about fertility preservation.

İntervention- Using the educational platform

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women of reproductive age between the ages of 18 and 45,
• Diagnosed with early stage cervical cancer, ovarian cancer, tubal cancer and endometrial cancer and whose treatment has not started,
• Those who have a smartphone and can use the platform,
• Volunteering and giving informed consent,
• Turkish literate,
• Individuals who do not report mental problems
• Do not have children,
• Marital status is married or single.

You may not qualify if:

• Neurological disease (e.g., stroke, multiple sclerosis) or cognitive impairment,
• Advanced-stage gynecologic cancers,
• Failure to complete the follow-up period,
• Initiation of oncologic treatment during the study period,
• Non-completion or incomplete completion of the data collection instruments,
• Non-use of the platform among participants allocated to the intervention group,
• History of prior cancer treatment.

Sponsors & Collaborators

• Biruni University: lead
• Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization: collaborator

Study Sites (1)

Biruni University

Istanbul, Zeytinburnu, 34020, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Fertility Preservation

Intervention Hierarchy (Ancestors)

Reproductive Techniques, Assisted; Reproductive Techniques; Therapeutics; Tissue and Organ Harvesting; Transplantation; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Nezihe KIZILKAYA BEJI, Professor

  Biruni University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nezihe KIZILKAYA BEJI, Professor

CONTACT

90+ 0532 502 34 94; nbeji@biruni.edu.tr

Huriye Sena Kuruc, MSc

CONTACT

90+ 0531 458 13 13; skuruc@biruni.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The study will include women aged 18-45 with early-stage gynecological cancer (cervix, ovary, tube, endometrium) at Prof. Dr. Cemil Tascioglu City Hospital, untreated. Participants must have Turkish literacy and internet access. Sample size, calculated with G\*Power, is 140 total (70 per group). In study, In the intervention group (n = 70), the mobile application will be downloaded and demonstrated to the participants. In the control group (n = 70) will receive only a printed brochure containing the same content as the mobile application.

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: June 11, 2026
• Study Start (Estimated): September 2, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)