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

NCT ID: NCT06400199

Last Updated: 2024-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-01

Study Completion Date

2024-07-01

Brief Summary

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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.

Detailed Description

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Conditions

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Gender Dysphoria, Adolescent

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

10 Years

Maximum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Amsterdam UMC, location VUmc

OTHER

Sponsor Role lead

Responsible Party

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J.A.F. Huirne

Prof. dr. J.A.F. Huirne

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Judith Huirne, MD, PHD, PROF

Role: PRINCIPAL_INVESTIGATOR

Amsterdam UMC

Locations

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Amsterdam UMC, location AMC

Amsterdam, , Netherlands

Site Status RECRUITING

Amsterdam UMC, Location VU Medical Center

Amsterdam, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Tessa Stolk, MD

Role: CONTACT

+31623844827

Norah van Mello, MD, PHD

Role: CONTACT

Facility Contacts

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Judith Huirne, Prof. Dr.

Role: primary

020-5669111

Lisa Trommelen, MD.

Role: backup

0628212618

Judith AF Huirn, MD, PhD

Role: primary

020-5663654

References

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Peri A, Ahler A, Gook D, O'Connell MA, Bourne H, Nightingale M, Telfer M, Jayasinghe Y, Pang KC. Predicting successful sperm retrieval in transfeminine adolescents after testicular biopsy. J Assist Reprod Genet. 2021 Oct;38(10):2735-2743. doi: 10.1007/s10815-021-02293-z. Epub 2021 Aug 23.

Reference Type BACKGROUND
PMID: 34424432 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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2022.0303

Identifier Type: -

Identifier Source: org_study_id

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