Gender Dysphoria, AdolescentTESENCT06400199
Fertility Preservation for Transfeminine Adolescents Via Semen Cryopreservation or Testicular Sperm Extraction
An observational study of Gender Dysphoria, Adolescent, run by Amsterdam UMC, location VUmc at 2 sites in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 18 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Gender Dysphoria, Adolescent
- How many people
- 40 participants
- Where
- 2 sitesNetherlands
- Study dates
- 1 Jul 2022to 1 Jul 2024
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Study population: assigned male at birth adolescents with gender dysphoria who wish fertilty preservation before the start of puberty suppression.
Who may be able to join
- Before start of puberty suppresion with a wish for fertility preservation
- After discontinuing puberty suppersion before the start of hormone therapy
Who cannot join
- Tanner stage > 4/5
Trial locations and contacts
2 sites in 1 country.
Norah van Mello, MD, PHD contact
Netherlands2 sites, 2 recruiting
- Recruiting
Amsterdam UMC, location AMC
Amsterdam, 1105 AZ
Judith Huirne, Prof. Dr., 020-5669111, j.huirne@amsterdamumc.nl
Lisa Trommelen, MD., 0628212618, l.m.trommelen@amsterdamumc.nl
- Recruiting
Amsterdam UMC, Location VU Medical Center
Amsterdam
Judith AF Huirn, MD, PhD, 020-5663654, secretariaat-vrouwenkliniek@amsterdamumc.nl
About this study
Official title: 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.
- Conditions
- Gender Dysphoria, Adolescent
- Keywords
- Testicular sperm extraction, Fertility preservation, Puberty suppresion
- Medical subject headings
- Gender Dysphoria
What is being measured
The primary outcome is the main question the study is designed to answer.
What parameter is best in predicting successful fertility preservation (i.e. spermatazoa are present)
Testicular volume
Measured: 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)
serum testosteron
Measured: 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)
serum LH
Measured: 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)
Serum FSH
Measured: 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)
Serum SHBG
Measured: Most recent before the TESE of semen cryopreservation no longer than 3 months old
Secondary outcomes (2)
How do adolescents and parents experience fertility preservation
self-constructed questionnaires and semi-structed interviews
Measured: 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
semi-structed interviews
Measured: 1 month post fertility preservation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start1 Jul 2022
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gender Dysphoria, AdolescentStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, J.A.F. Huirne, Amsterdam UMC, location VUmc
- Investigators
- Judith Huirne, MD, PHD, PROF, Principal investigator, Amsterdam UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06400199
- Sponsor's protocol ID
- 2022.0303
- Acronym
- TESE
- Status last verified
- May 2024
- First submitted
- 1 Nov 2023
- Last updated
- 6 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 34424432
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Succesfull Fertility Preservation for Transfeminine Adolescents Via Semen Cryopreservation or Testicular Sperm Extraction
- ClinicalTrials.gov ID
- NCT06400199
- Acronym / sponsor ID
- TESE / 2022.0303
- Conditions
- Gender Dysphoria, Adolescent
- Keywords
- Testicular sperm extraction, Fertility preservation, Puberty suppresion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 6 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 10 to 18 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- assigned male at birth adolescents with gender dysphoria who wish fertilty preservation before the start of puberty suppression.
Key inclusion criteria (2 listed)
- Before start of puberty suppresion with a wish for fertility preservation
- After discontinuing puberty suppersion before the start of hormone therapy
Key exclusion criteria (1 listed)
- Tanner stage > 4/5
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
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
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
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
2 secondary outcomes
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.
How do adolescents and parents experience fertility preservation
Time frame: 1 month post fertility preservation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2024.
- Background: PubMed 34424432Peri 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Norah van Mello, MD, PHD contact
Judith Huirne, MD, PHD, PROF principal investigator
Amsterdam UMC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gender Dysphoria, Adolescent, run by Amsterdam UMC, location VUmc at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tessa Stolk, MD (+31623844827, t.h.stolk@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06400199, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2024.