Fertility PreservationNCT07642531
A Modular Cloud Platform For Fertility Preservation
A study testing Developing a Modular Cloud-Based Platform to guide decision-making in fertility preservation in people with Fertility Preservation and Gynecologic Cancers, run by Biruni University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Fertility Preservation, Gynecologic Cancers
- What is being tested?
- Developing a Modular Cloud-Based Platform to guide decision-making in fertility preservation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Sep 2026to 1 Jan 2027
- Phase
- Interventional
- 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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Biruni University
Istanbul, Zeytinburnu, 34020
About this study
Official title: A Modular CLoud Based Platform To Enhance Fertility Preservation Awareness: Design, Pilot Testing And Randomized Controlled Trial
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).
Read the detailed description
This is a randomized controlled experimental study. The research was carried out in the Prof. Dr. Cemil Tascioglu City Hospital.
- Conditions
- Fertility Preservation, Gynecologic Cancers
- Being tested
- Developing a Modular Cloud-Based Platform to guide decision-making in fertility preservation
- Keywords
- fertility, gynecologic cancer, fertility preservation, mobile application
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Developing a Modular Cloud-Based Platform to guide decision-making in fertility preservationOther
In this study, a modular cloud-based platform will be developed to raise awareness about fertility preservation.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Developing a Modular Cloud-Based Platform to guide decision-making in fertility preservation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 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.
Measured: 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.
Measured: 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
Measured: Change from beginning of the study and after 3 weeks of after the mobile application is given
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start2 Sep 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fertility PreservationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Collaborators
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Responsible party
- Principal investigator, Nezihe KIZILKAYA BEJI, Biruni University
- Investigators
- Nezihe KIZILKAYA BEJI, Professor, Principal investigator, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07642531
- Sponsor's protocol ID
- KAD-FR-42
- Status last verified
- Jun 2026
- First submitted
- 8 Jun 2026
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The inverstigators did not obtain permission from the participants to share their data with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Modular CLoud Based Platform To Enhance Fertility Preservation Awareness: Design, Pilot Testing And Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07642531
- Acronym / sponsor ID
- KAD-FR-42
- Conditions
- Fertility Preservation, Gynecologic Cancers
- Keywords
- fertility, gynecologic cancer, fertility preservation, mobile application
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Collaborators
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Study start
- 2 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 11 Jun 2026 (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 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).
Detailed description
This is a randomized controlled experimental study. The research was carried out in the Prof. Dr. Cemil Tascioglu City Hospital.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Developing a Modular Cloud-Based Platform to guide decision-making in fertility preservationProf. 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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,
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Developing a Modular Cloud-Based Platform to guide decision-making in fertility preservationIn this study, a modular cloud-based platform will be developed to raise awareness about fertility preservation. | Other | İntervention- Using the educational platform |
Primary outcome
Awareness rates regarding fertility preservation options among patients in the experimental and control groups
Time frame: Change from beginning of the study and after 3 weeks of after the mobile application is given
These data will be obtained through the answers given to the "Awareness status questionnaire for fertility protection".
fertility preservation knowledge scores
Time frame: Change from beginning of the study and after 3 weeks of after the mobile application is given
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.
fertility preservation attitude scores
Time frame: Change from beginning of the study and after 3 weeks of after the mobile application is given
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.
Acceptance of fertility preservation
Time frame: Change from beginning of the study and after 3 weeks of after the mobile application is given
number of patients undergoing fertility preservation procedures
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 12 Jun 2026.
- Individual participant dataSharing planned: No. The inverstigators did not obtain permission from the participants to share their data with other researchers.
Related trials for Fertility Preservation
RecruitingObservational study
Gonadal Tissue Freezing for Fertility Preservation in Individuals at Risk for Ovarian Dysfunction, Premature Ovarian Insufficiency and Clinically Indicated Gonadectomy
Turner Syndrome, Post-menarcheal Adolescents
RecruitingObservational study
Follicular Flushing Versus Direct Aspiration in Transabdominal Oocyte Retrieval
Fertility Preservation
Recruiting
Investigating the Efficacy of a Paediatric Fertility Preservation Decision Aid in Parents and Adolescents and Young Adults (CAYA) Cancer Survivors
Unmet Fertility Information Needs
RecruitingPhase 4
Intranasal Nafarelin For Triggering Oocyte Maturation
Fertility Preservation
RecruitingPhase 2
Weight-loss Drug for Fertility-Sparing Treatment of Atypical Hyperplasia and Low-grade Cancer of the Endometrium
Endometrial Cancer, Atypical Hyperplasia
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.
Nezihe KIZILKAYA BEJI, Professor principal investigator
Biruni University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Developing a Modular Cloud-Based Platform to guide decision-making in fertility preservation in people with Fertility Preservation and Gynecologic Cancers, run by Biruni 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 8 inclusion and 7 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 12 Jun 2026. 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 Nezihe KIZILKAYA BEJI, Professor (90+ 0532 502 34 94, nbeji@biruni.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Awareness rates regarding fertility preservation options among patients in the experimental and control groups (time frame: Change from beginning of the study and after 3 weeks of after the mobile application is given). 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?
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 12 Jun 2026.