Clinical trial NCT06400199: Fertility Preservation for Transfeminine Adolescents Via Semen Cryopreservation or Testicular Sperm Extraction
Official title: Succesfull Fertility Preservation for Transfeminine Adolescents Via Semen Cryopreservation or Testicular Sperm Extraction
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gender Dysphoria, Adolescent
Keywords: Testicular sperm extraction
Fertility preservation
Puberty suppresion
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
First posted: 2024-05-06
Enrollment: 40
Sex: MALE
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: What parameter is best in predicting successful fertility preservation (i.e. spermatazoa are present)
timeFrame: Most recent before the TESE of semen cryopreservation no longer than 3 months old
measure: What parameter is best in predicting successful fertility preservation (i.e. spermatazoa are present)
timeFrame: Most recent before the TESE of semen cryopreservation no longer than 3 months old
measure: What parameter is best in predicting successful fertility preservation (i.e. spermatazoa are present)
timeFrame: Most recent before the TESE of semen cryopreservation no longer than 3 months old
measure: What parameter is best in predicting successful fertility preservation (i.e. spermatazoa are present)
timeFrame: Most recent before the TESE of semen cryopreservation no longer than 3 months old
measure: What parameter is best in predicting successful fertility preservation (i.e. spermatazoa are present)
timeFrame: Most recent before the TESE of semen cryopreservation no longer than 3 months old
Secondary outcomes:
measure: How do adolescents and parents experience fertility preservation
timeFrame: After refferal to fertility preservation specialist, after every 3 months after the start of Tanner 2, 1 month after the fertility preservation.
measure: How do adolescents and parents experience fertility preservation
timeFrame: 1 month post fertility preservation
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, location AMC
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, Location VU Medical Center
Study officials:
affiliation: Amsterdam UMC
name: Judith Huirne, MD, PHD, PROF
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.