Infertility, FemaleNCT07038174
A Study to Evaluate the Effectiveness of a Web-based Tool for Fertility Preservation in Cancer Patients
A study testing Fertility preservation decision aid intervention group in people with Infertility, Female and Neoplasms, run by National Cancer Center, Korea.
Trial summary
[Background] The number of young cancer patients is increasing, and they may experience impairment or loss of reproductive function due to cancer treatments such as surgery, radiation therapy, and chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Infertility, Female, Neoplasms
- What is being tested?
- Fertility preservation decision aid intervention group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2025to 31 Dec 2025
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female cancer patients aged 18 to 40 who received treatment at the National Cancer Center between June 2025 and December 2025
- Voluntarily agreed to participate in the study
- Able to read, write, and communicate in Korean without difficulty
Who cannot join
- Patients who had already lost fertility prior to participating in the study
- Patients who had already undergone, or were scheduled to undergo, a specific fertility preservation procedure
About this study
Official title: A Study for Development and Testing of Fertility Preservation Decision Aid for Young Cancer Patients
[Background] The number of young cancer patients is increasing, and they may experience impairment or loss of reproductive function due to cancer treatments such as surgery, radiation therapy, and chemotherapy.
Although various medical methods to preserve fertility have been developed, due to the complexity and medical specialization of these methods, there is an urgent need to support understanding and decision-making regarding these options in clinical practice.
Read more
While referrals to fertility specialists for counseling are possible, most young cancer patients do not receive such consultations before treatment. Even those who do often report decisional conflict due to confusion about the information and difficulty in reflecting personal values in the decision-making process.
Although decision aids have been developed in other countries, cultural, linguistic, and healthcare system differences make it difficult to apply these tools in Korea.
Therefore, there is a need to develop a decision aid tailored to female cancer patients in Korea for use in local clinical settings to support fertility preservation decisions.
[Study Objective] To develop a web-based decision aid and evaluate its impact on decisional conflict, fertility preservation-related knowledge, decision self-efficacy, depression, and quality of life, in order to assess the effectiveness of the decision aid.
[Study Hypothesis]
The use of a web-based decision aid for fertility preservation will:
Reduce decisional conflict experienced by cancer patients during the decision-making process; Improve fertility preservation-related knowledge and decision self-efficacy; Reduce levels of depression and improve quality of life.
[Study Plan]
- Study Design
- Randomized clinical study
- Prospective study
- Two-arm randomized controlled trial (RCT)
- Study Method Female cancer patients visiting the outpatient clinic of the National Cancer Center will be screened to determine eligibility based on inclusion and exclusion criteria.
Patients who meet the criteria and voluntarily agree to participate will be enrolled in the study.
Participants will be randomly assigned to either the intervention group (who will use the decision aid) or the control group (who will receive standard cancer treatment as planned at the Cancer Center without any special tools).
The decision aid will be provided to the intervention group immediately after randomization. The control group will not receive any additional tools.
Outcomes will be measured at three time points for the intervention group: before the intervention (T0), one week after the intervention (T1), and one month after the intervention (T2).
For the control group, measurements will be taken at the same time points: immediately after randomization (T0), one week later (T1), and one month later (T2).
- Conditions
- Infertility, Female, Neoplasms
- Being tested
- Fertility preservation decision aid intervention group
- Medical subject headings
- Infertility, Female, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fertility preservation decision aid intervention groupOther
Visited the website containing the web-based decision aid regarding fertility preservation at least once before cancer treatment initiation to independently use the tool in a private setting
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Received only the planned cancer treatment without any additional intervention |
| Fertility preservation decision aid intervention group | Experimental | Visited the website containing the web-based decision aid regarding fertility preservation at least once before cancer treatment initiation to independently use the tool in a private setting Receives: Other: Fertility preservation decision aid intervention group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decisional conflict score
Name of the measurement: Decisional conflict score assessed by the Decisional Conflict Scale (DCS)
Measurement tool: The Decisional Conflict Scale (DCS) - low literacy version Measure description: The level of decisional conflict experienced by participants regarding a health-related decision will be assessed using the Decisional Conflict Scale (DCS) - low literacy version, a validated 10-item questionnaire. Each item is rated on yes(0), unsure(2), no(4), and scores are converted to a 0-100 scale, with higher scores indicating greater decisional conflict. The unit of measure will be the mean total score on the DCS at the specified timepoint. Subscale scores (e.g., uncertainty, informed, values clarity, support, and effective decision) may also be calculated.
Unit of measure: Mean scores range from 0 (no decisional conflict) to 100 (extremely high decisional conflict)
Measured: Before the intervention, one week after the intervention, and one month after the intervention.
Secondary outcomes (7)
Knowledge about fertility preservation
Name of the measurement: Knowledge about fertility preservation Measurement tool: Questionnaire developed by researchers Measure description: Knowledge about fertility preservation will be assessed using a questionnaire developed by researchers. To develop the questionnaire items, guidelines and prior studies on the development and evaluation of fertility preservation decision aids will be reviewed to extract essential and frequently asked information for cancer patients. A panel of experts will be consulted to evaluate the relevance of each item. After item selection, researchers will develop corresponding questions and response options, which will be reviewed and revised based on expert feedback.
The measurement tool will be a customized questionnaire assessing FP knowledge, and the unit of measure will be the percentage of participants who answer each knowledge item correctly.
Unit of measure: % of participants with correct answers (per item)
Measured: Before the intervention, one week after the intervention, and one month after the intervention.
Depression severity
Name of the measurement: Depression severity assessed by the Patient Health Questionnaire-9 (PHQ-9) Measurement tool: Patient Health Questionnaire-9 (PHQ-9) Measure description: Depression severity will be assessed using the Patient Health Questionnaire-9 (PHQ-9), a validated 9-item self-report questionnaire widely used to screen for and measure the severity of depressive symptoms. Each of the 9 items is scored on a 4-point Likert scale from 0 (not at all) to 3 (nearly every day). The total score ranges from 0 to 27, with higher scores indicating greater severity of depression. The unit of measure will be the mean total PHQ-9 score at each time point. Depression severity levels based on PHQ-9 score will be categorized as follows: 0-4: Minimal or no depression/5-9: Mild depression/10-14: Moderate depression/15-19: Moderately severe depression/20-27: Severe depression
Unit of measure: Mean PHQ-9 total score (range: 0-27; higher scores = worse outcome)
Measured: Before the intervention, one week after the intervention, and one month after the intervention.
Health-Related Quality of Life
Name of the measurement: Health-Related Quality of life assessed by the EuroQol 5-dimension 5-level (EQ-5D-5L) Measurement tool: EuroQol 5-dimension 5-level (EQ-5D-5L) Measure description: Health-related quality of life will be assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) instrument, a standardized and validated questionnaire developed by the EuroQol Group. The EQ-5D-5L evaluates five dimensions of health: Mobility, Self-care, Usual activities, Pain/discomfort, Anxiety/depression Each dimension is rated on 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses generate a health profile that is converted into a utility index score based on a population-specific value set. The units of measure is EQ-5D-5L index score (range from <0 [worse than death] to 1 [full health])
Unit of measure: Mean EQ-5D-5L index score (from 0 [worse than death] to 1 [full health])
Measured: Before the intervention, one week after the intervention, and one month after the intervention.
Decision-Making Confidence
Name of the measurement: Decision-Making Confidence Assessed by the Decision Self-Efficacy Scale Measurement tool: Decision self-efficacy scale Measure description: Confidence in decision-making will be assessed using the Decision Self-Efficacy Scale, a validated 11-item questionnaire developed to measure individuals' self-confidence in engaging in health-related decision-making. Each item is rated on a 5-point Likert scale ranging from 0 (not at all confident) to 4 (very confident). The total raw score (0-44) is converted to a standardized score ranging from 0 to 100, where higher scores indicate greater decision-making self-efficacy. The scale assesses perceived ability to ask questions, express opinions, evaluate options, and participate in decisions about one's health care.
Unit of measure: Mean score (0-100); higher = better decision-making self-efficacy
Measured: Before the intervention, one week after the intervention, and one month after the intervention.
Counselling on fertility preservation
Name of the measurement: Counseling on fertility preservation Measurement tool: Study-developed question (investigator-designed, not previously validated) Measure description:This outcome will assess whether participants received any counseling regarding fertility preservation after participation in the clinical trial. A validated measurement tool will not be used; instead, participants will be asked a direct yes/no question about whether they were counseled on fertility preservation options (e.g., egg or embryo freezing, ovarian tissue preservation) by a healthcare provider.
Unit of measure: % of participants reporting receipt of counseling
Measured: one month after the intervention
Decision-making about fertility preservation
Name of the measurement: Decision-making about fertility preservation Measurement tool: Study-developed question (investigator-designed, not previously validated) Measure description: This outcome assesses whether participants have made an actual decision regarding fertility preservation after participation in the clinical trial. A study-developed question will be used to ask participants directly whether they have decided to undergo fertility preservation procedures (such as egg freezing, embryo freezing, or ovarian tissue preservation) or have decided against it.
The measurement tool is a study-specific, investigator-developed yes/no question, not based on a previously validated instrument.
Unit of measure: % of participants reporting receipt of counseling
Measured: one month after the intervention
Readiness for decision-making
Name of the measurement: Readiness for decision-making assessed by the Preparation for Decision-Making Scale Measurement tool: Preparation for Decision-Making Scale Measure description: Readiness for decision-making will be evaluated using the Preparation for Decision-Making Scale (PrepDM Scale), a validated questionnaire designed to assess how well individuals feel prepared to make health-related decisions after receiving information or decision support. The scale consists of 10 items, each rated on a 5-point Likert scale ranging from 1 (not at all) to 5 (a great deal). The total score is calculated by summing item scores, then converted to a standardized score ranging from 0 to 100, where higher scores indicate greater perceived preparedness for decision-making. The unit of measure will be the mean PrepDM score (0-100).
Unit of measure: Mean score (0-100); higher = better preparation for decision-making
Measured: one week after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start30 Jun 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infertility, FemaleStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07038174
- Sponsor's protocol ID
- NCC2024-0050
- Status last verified
- Jan 2025
- First submitted
- 11 Jun 2025
- Last updated
- 26 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant Data (IPD) will not be shared due to concerns about participant privacy and the potential risk of re-identification, especially given the sensitive nature of the data. In addition, there are no current resources or infrastructure in place to support secure data sharing.
Publications
Jang J, Lee EM, Chung YK, Lee DO, Park HJ, Yim GW, Lee KS, Kim JH, Ko AR, Hong JH, Kang S. Development and pilot testing of a personalised decision aid for decision-making regarding fertility preservation in young female patients with cancer: a study protocol. BMJ Open. 2025 Aug 12;15(8):e090759. doi: 10.1136/bmjopen-2024-090759.
PubMed 40803737
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study for Development and Testing of Fertility Preservation Decision Aid for Young Cancer Patients
- ClinicalTrials.gov ID
- NCT07038174
- Acronym / sponsor ID
- NCC2024-0050
- Conditions
- Infertility, Female, Neoplasms
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Study start
- 30 Jun 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 26 Jun 2025 (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.
[Background] The number of young cancer patients is increasing, and they may experience impairment or loss of reproductive function due to cancer treatments such as surgery, radiation therapy, and chemotherapy.
Although various medical methods to preserve fertility have been developed, due to the complexity and medical specialization of these methods, there is an urgent need to support understanding and decision-making regarding these options in clinical practice.
While referrals to fertility specialists for counseling are possible, most young cancer patients do not receive such consultations before treatment. Even those who do often report decisional conflict due to confusion about the information and difficulty in reflecting personal values in the decision-making process.
Although decision aids have been developed in other countries, cultural, linguistic, and healthcare system differences make it difficult to apply these tools in Korea.
Therefore, there is a need to develop a decision aid tailored to female cancer patients in Korea for use in local clinical settings to support fertility preservation decisions.
[Study Objective] To develop a web-based decision aid and evaluate its impact on decisional conflict, fertility preservation-related knowledge, decision self-efficacy, depression, and quality of life, in order to assess the effectiveness of the decision aid.
[Study Hypothesis]
The use of a web-based decision aid for fertility preservation will:
Reduce decisional conflict experienced by cancer patients during the decision-making process; Improve fertility preservation-related knowledge and decision self-efficacy; Reduce levels of depression and improve quality of life.
[Study Plan]
- Study Design
- Randomized clinical study
- Prospective study
- Two-arm randomized controlled trial (RCT)
- Study Method Female cancer patients visiting the outpatient clinic of the National Cancer Center will be screened to determine eligibility based on inclusion and exclusion criteria.
Patients who meet the criteria and voluntarily agree to participate will be enrolled in the study.
Participants will be randomly assigned to either the intervention group (who will use the decision aid) or the control group (who will receive standard cancer treatment as planned at the Cancer Center without any special tools).
The decision aid will be provided to the intervention group immediately after randomization. The control group will not receive any additional tools.
Outcomes will be measured at three time points for the intervention group: before the intervention (T0), one week after the intervention (T1), and one month after the intervention (T2).
For the control group, measurements will be taken at the same time points: immediately after randomization (T0), one week later (T1), and one month later (T2).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Received only the planned cancer treatment without any additional intervention |
| Fertility preservation decision aid intervention group | Experimental | Other: Fertility preservation decision aid intervention groupVisited the website containing the web-based decision aid regarding fertility preservation at least once before cancer treatment initiation to independently use the tool in a private setting |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Female cancer patients aged 18 to 40 who received treatment at the National Cancer Center between June 2025 and December 2025
- Voluntarily agreed to participate in the study
- Able to read, write, and communicate in Korean without difficulty
Key exclusion criteria (2 listed)
- Patients who had already lost fertility prior to participating in the study
- Patients who had already undergone, or were scheduled to undergo, a specific fertility preservation procedure
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 |
|---|---|---|
| Fertility preservation decision aid intervention groupVisited the website containing the web-based decision aid regarding fertility preservation at least once before cancer treatment initiation to independently use the tool in a private setting | Other | Fertility preservation decision aid intervention group |
Primary outcome
Decisional conflict score
Time frame: Before the intervention, one week after the intervention, and one month after the intervention.
Name of the measurement: Decisional conflict score assessed by the Decisional Conflict Scale (DCS) Measurement tool: The Decisional Conflict Scale (DCS) - low literacy version Measure description: The level of decisional conflict experienced by participants regarding a health-related decision will be assessed using the Decisional Conflict Scale (DCS) - low literacy version, a validated 10-item questionnaire. Each item is rated on yes(0), unsure(2), no(4), and scores are converted to a 0-100 scale, with higher scores indicating greater decisional conflict. The unit of measure will be the mean total score on the DCS at the specified timepoint. Subscale scores (e.g., uncertainty, informed, values clarity, support, and effective decision) may also be calculated. Unit of measure: Mean scores range from 0 (no decisional conflict) to 100 (extremely high decisional conflict)
7 secondary outcomes
Knowledge about fertility preservation
Time frame: Before the intervention, one week after the intervention, and one month after the intervention.
Depression severity
Time frame: Before the intervention, one week after the intervention, and one month after the intervention.
Health-Related Quality of Life
Time frame: Before the intervention, one week after the intervention, and one month after the intervention.
Decision-Making Confidence
Time frame: Before the intervention, one week after the intervention, and one month after the intervention.
Counselling on fertility preservation
Time frame: one month after the intervention
Decision-making about fertility preservation
Time frame: one month after the intervention
Readiness for decision-making
Time frame: one week after the intervention
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 26 Jun 2025.
- Derived from this study: PubMed 40803737Jang J, Lee EM, Chung YK, Lee DO, Park HJ, Yim GW, Lee KS, Kim JH, Ko AR, Hong JH, Kang S. Development and pilot testing of a personalised decision aid for decision-making regarding fertility preservation in young female patients with cancer: a study protocol. BMJ Open. 2025 Aug 12;15(8):e090759. doi: 10.1136/bmjopen-2024-090759.
- Individual participant dataSharing planned: No. Individual Participant Data (IPD) will not be shared due to concerns about participant privacy and the potential risk of re-identification, especially given the sensitive nature of the data. In addition, there are no current resources or infrastructure in place to support secure data sharing.
Related trials for Infertility, Female
RecruitingObservational study
Safety and Efficacy of Corifollitropin Alfa N02 Injection in Elderly Women Undergoing Assisted Reproductive Technology (ART)
Infertility
RecruitingObservational study
Inherited Reproductive Disorders
Genetic Disorder, Infertility
RecruitingObservational study
Biorepository in Participants Who Undergo OTC for Gonadotoxic Therapy
Acute Ovarian Failure, Infertility
Not yet recruitingObservational study
Linzagolix in Adenomyosis and Recurrent Implantation Failure
Adenomyosis of Uterus, Implantation Failure
Recruiting
225 IU Versus 300 IU Starting FSH Dose in PPOS for Good-Prognosis Women
Infertility (IVF Patients), Infertility Assisted Reproductive Technology
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Fertility preservation decision aid intervention group in people with Infertility, Female and Neoplasms, run by National Cancer Center, Korea.
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 3 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: opening soon, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decisional conflict score (time frame: Before the intervention, one week after the intervention, and one month after the intervention.). 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 NCT07038174, which also lists 1 linked publication.
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 26 Jun 2025.