Decision Aid for Elective Egg Freezing (DAEEF)

April 15, 2026 updated by: National Taiwan University Hospital

Knowledge, Decision-making, and Oocyte Cryopreservation Outcomes in Taiwanese Women Considering Elective Egg Freezing: a Randomized Controlled Trial

The goal of this clinical trial is to evaluate whether a culturally tailored decision aid can improve decision-making and clinical outcomes for Taiwanese women considering elective egg freezing.

The main questions it aims to answer are:

Does the decision aid improve women's knowledge about elective egg freezing and help clarify their personal values? Does the decision aid reduce decision regret and psychological distress after making a decision about egg freezing?

Researchers will compare women who use the decision aid with those who receive standard counseling to see if the tool improves knowledge, reduces distress and regret, and leads to better clinical outcomes (such as completing egg freezing or achieving a higher number of frozen oocytes).

Participants will:

  • Complete questionnaires assessing their baseline knowledge, attitudes, and values regarding egg freezing
  • Receive either the decision aid or standard counseling
  • Complete follow-up questionnaires to assess knowledge, distress, and decision regret
  • Have their clinical outcomes recorded, including whether they undergo egg freezing and the number of oocytes retrieved and frozen

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
    • Taiwan
      • Taipei, Taiwan, Taiwan, 100
        • National Taiwan University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Women aged 20 years or older.
  • Currently considering elective egg freezing (EEF).
  • Able to communicate and read Chinese fluently.
  • Have access to the internet and a mobile device (smartphone, tablet, or computer) to complete online questionnaires.

Exclusion Criteria:

  • Individuals who have previously completed oocyte cryopreservation.
  • Women undergoing fertility preservation due to malignancy (i.e., breast cancer).
  • Postmenopausal women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Experimental: Decision Aid
Other: elective egg freezing decision aid
The EEF decision aid used in this study is an evidence-based educational tool designed to support shared decision making. Its primary function is to provide clear, balanced, and structured information to help women make decisions that align with their personal values and reproductive goals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decision Regret Scale
Time Frame: 6 months, 24 months
The Decision Regret Scale (DRS) is a 5-item validated questionnaire used to assess distress or remorse after a healthcare decision. Each item is scored on a 5-point Likert scale. Scores are transformed to a 0-100 scale, with higher scores indicating greater decision regret (worse outcome).
6 months, 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knowledge score regarding elective egg freezing
Time Frame: baseline, 6 months, 24 months
Knowledge regarding elective egg freezing will be assessed using a self-developed questionnaire consisting of multiple-choice items covering fertility decline, success rates, risks, and procedural aspects. Each correct answer is awarded 1 point. Scores are transformed to a 0-100 scale, with higher scores indicating greater knowledge (better outcome).
baseline, 6 months, 24 months
Decisional conflict scale
Time Frame: baseline, 6 months, 24 months
The Decisional Conflict Scale (DCS) is a 16-item validated instrument measuring personal perceptions of uncertainty in choosing options, modifiable factors contributing to uncertainty, and perceived effective decision-making. Each item is scored on a 5-point Likert scale. Scores are converted to a 0-100 scale, with higher scores indicating greater decisional conflict (worse outcome).
baseline, 6 months, 24 months
Depression anxiety stress scale
Time Frame: baseline, 6 months, 24 months
The Depression Anxiety Stress Scales-21 (DASS-21) is a 21-item validated questionnaire assessing symptoms of depression, anxiety, and stress across three subscales. Each item is scored from 0 to 3. Subscale scores range from 0 to 21 (or 0-42 after standard multiplication), with higher scores indicating greater psychological distress (worse outcome).
baseline, 6 months, 24 months
Elective egg freezing treatment completion rate
Time Frame: From enrollment to the end of intervention at 2 years.
Treatment completion is defined as participants who undergo at least one completed oocyte retrieval cycle for elective egg freezing following enrollment. The completion rate will be calculated as the proportion of participants who complete treatment out of all enrolled participants.
From enrollment to the end of intervention at 2 years.
Number of oocytes cryopreserved per participant
Time Frame: From enrollment to the end of intervention at 2 years.
The total number of mature oocytes (metaphase II oocytes) successfully retrieved and cryopreserved per participant during the study period will be recorded. If participants undergo multiple cycles, the cumulative number of oocytes cryopreserved will be reported.
From enrollment to the end of intervention at 2 years.
Ovarian stimulation cycle cancellation rate
Time Frame: From enrollment to the end of intervention at 2 years.
Cycle cancellation is defined as initiation of ovarian stimulation without proceeding to oocyte retrieval. The cancellation rate will be calculated as the proportion of initiated cycles that are canceled prior to oocyte retrieval.
From enrollment to the end of intervention at 2 years.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Elective egg freezing attitudes and expectations (qualitative assessment)
Time Frame: baseline, 6 months, 24 months
Participants' attitudes, expectations, and reproductive planning regarding elective egg freezing will be assessed using investigator-developed open-ended questions. Responses will be analyzed using qualitative content analysis to identify key themes related to decision-making, perceived benefits and concerns, and future reproductive intentions.
baseline, 6 months, 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 13, 2026

Primary Completion (Estimated)

July 31, 2029

Study Completion (Estimated)

December 31, 2031

Study Registration Dates

First Submitted

April 9, 2026

First Submitted That Met QC Criteria

April 15, 2026

First Posted (Actual)

April 21, 2026

Study Record Updates

Last Update Posted (Actual)

April 21, 2026

Last Update Submitted That Met QC Criteria

April 15, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 202601216RINA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

De-identified individual participant data (IPD) will not be made publicly available due to the sensitive nature of the data, which includes personal reproductive decision-making, psychological assessments, and qualitative responses that may carry a risk of re-identification.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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