NCT07543445

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
69mo left

Started Apr 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
Apr 2026Dec 2031

First Submitted

Initial submission to the registry

April 9, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

April 13, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 21, 2026

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2029

Expected
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2031

Last Updated

April 21, 2026

Status Verified

April 1, 2026

Enrollment Period

3.3 years

First QC Date

April 9, 2026

Last Update Submit

April 15, 2026

Conditions

Elective Egg FreezingOocyte CryopreservationDecision AidEgg FreezingShared Decision MakingAssisted Reproductive TechnologyFertility Preservation

Keywords

elective egg freezingplanned oocyte cryopreservationfertility preservationdecision aidshared decision makingassisted reproductive technologyrandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • Decision Regret Scale

    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 Outcomes (6)

  • Knowledge score regarding elective egg freezing

    baseline, 6 months, 24 months

  • Decisional conflict scale

    baseline, 6 months, 24 months

  • Depression anxiety stress scale

    baseline, 6 months, 24 months

  • Elective egg freezing treatment completion rate

    From enrollment to the end of intervention at 2 years.

  • Number of oocytes cryopreserved per participant

    From enrollment to the end of intervention at 2 years.

  • +1 more secondary outcomes

Other Outcomes (1)

  • Elective egg freezing attitudes and expectations (qualitative assessment)

    baseline, 6 months, 24 months

Study Arms (2)

Decision Aid

EXPERIMENTAL
Other: elective egg freezing decision aid

Control

NO INTERVENTION

Interventions

elective egg freezing decision aidOTHER

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.

Decision Aid

Eligibility Criteria

Age20 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly biological female who has ovaries and oocytes are eligible for our study.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan, 100, Taiwan

Location

Central Study Contacts

Jou-Chien Liao, Doctor

CONTACT

+886 987877611ruth5056@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2026

First Posted

April 21, 2026

Study Start

April 13, 2026

Primary Completion (Estimated)

July 31, 2029

Study Completion (Estimated)

December 31, 2031

Last Updated

April 21, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

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.

Locations

TW(1)