NCT05120245

Brief Summary

Patients in this study will be asked how they feel about the decision to freeze gametes, using a validated questionnaire. In addition, a number of questions with free text fields will be included in the questionnaire to write down any reasons for their satisfaction or regret. In a second part, the intention to use the frozen material will be assessed. We focus on techniques with real perspectives (e.g. cryopreservation of oocytes and sperm cells) and not on techniques that are more experimental for later use (cryopreservation of ovarian and testicular tissue).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 8, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 15, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 15, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

2 years

First QC Date

September 15, 2021

Last Update Submit

September 5, 2024

Conditions

Fertility Preservation in Transgender Persons

Outcome Measures

Primary Outcomes (3)

  • Transgender people's retrospective view of the decision

    Study of transgender persons' retrospective evaluation of the decision to freeze egg or sperm cells prior to gender-confirming hormonal or surgical treatment in transition

    fertility preservation between june 2015 and june 2020 (5 years). Survey in 2021 (up to 7 years after preservation)

  • Satisfaction/ regret about the decision

    Survey on the reasons for satisfaction/ regret regarding the decision to freeze egg cells or sperm cells prior to gender-confirming hormonal or surgical treatment in the context of transition

    fertility preservation between june 2015 and june 2020 (5 years). Survey in 2021 (up to 7 years after preservation)

  • Intention

    Examination of the intention to use the frozen egg cells or sperm cells to fulfil a desire to have children

    fertility preservation between june 2015 and june 2020 (5 years). Survey in 2021 (up to 7 years after preservation)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

transgender personen

You may qualify if:

  • Dutch speaking
  • Sperm or oocyte preservation between june 2015 and june 2020. Survey in 2021

You may not qualify if:

  • Ovarian and testicular tissue cryopreservation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghent University hospital

Ghent, 9000, Belgium

Location

Study Officials

  • Stoop

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2021

First Posted

November 15, 2021

Study Start

July 8, 2021

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)