Fertility Preservation for Transfeminine Adolescents Via Semen Cryopreservation or Testicular Sperm Extraction (TESE)

May 1, 2024 updated by: J.A.F. Huirne, Amsterdam UMC, location VUmc

Succesfull Fertility Preservation for Transfeminine Adolescents Via Semen Cryopreservation or Testicular Sperm Extraction

The goal of this observational cohort study is to identify and predict parameters for successful testicular sperm extraction (TESE) procedures or semen cryopreservation more accurately and to evaluate the decision making process and the experience of postponing or temporarily discontinuing puberty suppression to undergo successful fertility preservation. in transfeminine (assigned male at birth) adolescents. The main question[s] it aims to answer are:

  • What is the optimal timing for fertility preservation before the start or after temporarily discontinuing puberty suppression puberty suppression
  • How do transfeminine adolescents and their parents experience the decision making process of fertility preservation
  • how do transfeminine adolescents and their parents experienced postponing or temporarily discontinuing puberty suppression to undergo successful fertility preservation?

Participants will be asked to use their medical data, answer a questionnaire or participate in a (online) interview.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

40

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 Contact Backup

Study Locations

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

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

assigned male at birth adolescents with gender dysphoria who wish fertilty preservation before the start of puberty suppression.

Description

Inclusion Criteria:

  • Before start of puberty suppresion with a wish for fertility preservation
  • After discontinuing puberty suppersion before the start of hormone therapy

Exclusion Criteria:

  • Tanner stage > 4/5

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
What parameter is best in predicting successful fertility preservation (i.e. spermatazoa are present)
Time Frame: Most recent before the TESE of semen cryopreservation no longer than 3 months old
Testicular volume
Most recent before the TESE of semen cryopreservation no longer than 3 months old
What parameter is best in predicting successful fertility preservation (i.e. spermatazoa are present)
Time Frame: Most recent before the TESE of semen cryopreservation no longer than 3 months old
serum testosteron
Most recent before the TESE of semen cryopreservation no longer than 3 months old
What parameter is best in predicting successful fertility preservation (i.e. spermatazoa are present)
Time Frame: Most recent before the TESE of semen cryopreservation no longer than 3 months old
serum LH
Most recent before the TESE of semen cryopreservation no longer than 3 months old
What parameter is best in predicting successful fertility preservation (i.e. spermatazoa are present)
Time Frame: Most recent before the TESE of semen cryopreservation no longer than 3 months old
Serum FSH
Most recent before the TESE of semen cryopreservation no longer than 3 months old
What parameter is best in predicting successful fertility preservation (i.e. spermatazoa are present)
Time Frame: Most recent before the TESE of semen cryopreservation no longer than 3 months old
Serum SHBG
Most recent before the TESE of semen cryopreservation no longer than 3 months old

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
How do adolescents and parents experience fertility preservation
Time Frame: After refferal to fertility preservation specialist, after every 3 months after the start of Tanner 2, 1 month after the fertility preservation.
self-constructed questionnaires and semi-structed interviews
After refferal to fertility preservation specialist, after every 3 months after the start of Tanner 2, 1 month after the fertility preservation.
How do adolescents and parents experience fertility preservation
Time Frame: 1 month post fertility preservation
semi-structed interviews
1 month post fertility preservation

Collaborators and Investigators

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

Sponsor

Amsterdam UMC, location VUmc

Investigators

  • Principal Investigator: Judith Huirne, MD, PHD, PROF, Amsterdam UMC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

July 1, 2022

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

July 1, 2024

Study Registration Dates

First Submitted

November 1, 2023

First Submitted That Met QC Criteria

May 1, 2024

First Posted (Actual)

May 6, 2024

Study Record Updates

Last Update Posted (Actual)

May 6, 2024

Last Update Submitted That Met QC Criteria

May 1, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022.0303

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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