A Modular Cloud Platform For Fertility Preservation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorBiruni University
About this 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).
Eligibility criteria
Qualifiers
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,
Disqualifiers
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,
Trial design
Treatments tested in this trial
- Developing a Modular Cloud-Based Platform to guide decision-making in fertility preservation
Treatment groups
140 Participants
are divided into 2 treatment groupsSponsors and collaborators
Biruni University
Lead sponsor
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Collaborator
Source ClinicalTrials.gov