Testicular biopsies in young boys diagnosed with cancer to preserve future fertility- towards a safe and feasible autologous cell therapy in future.

Testicular biopsies in young boys diagnosed with cancer to preserve future fertility- towards a safe and feasible autologous cell therapy in future. - PRINCE project

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON52444

Enrollment

100

Registered

2021-07-07

Start date

2021-10-11

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

jongens met kanker en hoge kans op onvruchtbaarheid preserving fertility

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: -Young patients with malignancies treated with alkylating agents (CED >4000mg/m2), brain tumours treated with cranio-(spinal) irradiation and alkylating agents, total body irradiation, pelvic irradiation, testicular irradiation, and conditioning for stem cell transplantation. The boys and parents will be given an individual estimate on the probability of infertility in relation to their scheduled treatment. -Only if parents/legal guardians have signed consent. And in case boys > 12 years informed consent will be signed together with the informed consent of their parents -For follow up all boys included in the previous cohort at the Amsterdam UMC, location AMC who have undergone a testicular biopsy prior to start of chemotherapy during the period 2011-2018.

Exclusion criteria

Exclusion criteria: Malignancies located in the testis, history of bilateral cryptorchidism or testicular torsion, ability to ejaculate vital spermatozoa on masturbation or electro-stimulated ejaculation. Previous history or increased risk for pre-existing (congenital) gonadal insufficiency or known chromosomal abnormalities that affect male fertility.

Design outcomes

Primary

Measure	Time frame
-Successful cryopreservation of testicular tissue in which germ cells can be identified for later use in auto transplantation and follow up of previous cohort (Amsterdam UMC, location AMC) to register possible late complications. The presence of SSCs will be identified based on histological analyses (immuno-) characterization, possibly supported by flowcytometry and single cell sequencing -Successful sampling and storage of testicular tissue (cryosurvival of SSCs, ability to propagate SSCs in vitro) in combination with long-term follow-up of possible side-effects of the testicular biopsy in the boy (local defects, endocrine and exocrine function of the remaining testis).	—

Measure

Time frame

-Successful cryopreservation of testicular tissue in which germ cells can be identified for later use in auto transplantation and follow up of previous cohort (Amsterdam UMC, location AMC) to register possible late complications. The presence of SSCs will be identified based on histological analyses (immuno-) characterization, possibly supported by flowcytometry and single cell sequencing -Successful sampling and storage of testicular tissue (cryosurvival of SSCs, ability to propagate SSCs in vitro) in combination with long-term follow-up of possible side-effects of the testicular biopsy in the boy (local defects, endocrine and exocrine function of the remaining testis).

—

Secondary

Measure	Time frame
Long-term follow-up of possible side-effects of the testicular biopsy in the boy (local defects, endocrine and exocrine function of the remaining testis), post-pubertal fertility (as determined by semen analysis)and hormonal analysis (FSH LH testosterone and Inhibin B)	—

Countries

Netherlands

Outcome results