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Young adult men (≥18 years) cured of childhood cancer or hematological disorders for which they received high-risk gonadotoxic treatment during childhood and who have chosen to undergo a testicular biopsy procedure at a young age as a fertility preservation strategy.

Young adult men (≥18 years) cured of childhood cancer or hematological disorders for which they received high-risk gonadotoxic treatment during childhood and who have refused to undergo a testicular biopsy procedure at a young age as a fertility preservation strategy.

Spontaneously conceived young adults whose data on reproductive health have already been published (Belva F et al., 2016/2017/2019).

A physical examination to measure the patients' weight, height, body mass index, blood pressure and testicular volume using a Prader orchidometer and to determine the patients' Tanner stage (secondary sexual development).

Physical examination

A scrotum ultrasound to measure the patients' testicular volume and to investigate potential abnormalities in the testicular parenchyma.

Scrotum ultrasound

A morning blood sample to evaluate the serum levels of luteinizing hormone (LH), follicle-stimulating hormone (FSH), testosterone (T), estradiol (E2), inhibin B (INHB), thyroid-stimulating hormone (TSH), free thyroxine (FT4), insulin-like growth factor 1 (IGF1), prolactin (PRL), cortisol and adrenocorticotropic hormone (ACTH). Upon approval by the patient himself, a spare blood sample will be collected and retained for 5 years for subsequent research purposes limited to the context of the present study.

Blood sample

A semen analysis to evaluate ejaculate volume, sperm concentration, sperm motility, and sperm morphology. If sperm is found in the semen sample, an anti-sperm antibody test and a sperm DNA fragmentation test will be performed. Upon approval by the patient himself, the surplus of the semen sample will be retained for 5 years for subsequent research purposes limited to the context of the present study.

Semen analysis

Ellen Goossens, Prof. Dr.

The goal of this prospective comparative interventional cohort study is to assess the fertility status of young adult men (≥18 years) who received gonadotoxic treatment during childhood for the treatment of cancer or hematological disorders. These treatment protocols are highly gonadotoxic (i.e. they may cause later fertility problems) and therefore these patients have been proposed to store some testicular tissue during childhood as an option to preserve their fertility.

The main questions this study aims to answer are (1) the impact of the received gonadotoxic treatment on the later fertility status and (2) the additional impact of a testicular biopsy procedure (performed at a young age to harvest testicular tissue for storage) on the future fertility.

Participants will be asked to undergo a physical examination by a fertility specialist, to undergo a scrotal ultrasound, to give a blood sample, and to provide a semen sample.

Researchers will compare the patients\&amp;#39; fertility status between the different received gonadotoxic treatment protocols, between patients who underwent a testicular biopsy procedure at a young age and those who did not, and compare the patients\&amp;#39; fertility status with the reproductive health of spontaneously conceived young adults.

This study is a prospective comparative interventional cohort study.

The fertility status of young adults (≥18 years) cured of childhood cancer or hematological disorders for which they received high-risk gonadotoxic treatment (with an ≥80% risk of later fertility problems) during childhood will be compared between patients who did and those who did not undergo a testicular tissue biopsy procedure at a young age as a fertility preservation strategy in order to identify a possible association between the biopsy procedure (which is performed to harvest testicular tissue) and the later fertility outcome.

Their fertility status will also be compared to the reproductive health of spontaneously conceived young adults that has already been published (Belva F et al., 2016/2017/2019).

Fertility in Young Adults Who Did (Not) Store Testicular Tissue Before a Treatment Leading to Fertility Problems

Follow-up of Fertility in Young Adults Who Did or Did Not Store Testicular Tissue Before Gonadotoxic Treatment for Fertility Preservation

The patients' fertility status (physical examination, scrotum ultrasound, blood sample, semen analysis) will be evaluated once a year after cessation of the gonadotoxic treatment. Only in case of infertility (azoospermia) or subfertility (oligo-, astheno- or teratozoospermia), the different interventions will be repeated one year later as the recovery of spermatogenesis with return of sperm production may occur several years after gonadotoxic treatment.

Vrije Universiteit Brussel

Universitair Ziekenhuis Brussel

Head of research group BITE

Central Nervous System Depressants

Anesthetics

testicular tissue biopsy during general anesthesia

testicular tissue biopsy

Fabienne Gumy-Pause, Dr

Tamara Diesch-Furlanetto, Dr

Maja Beck Popovic, Dr

Fabienne Gumy-Pause

Background:

Due to the remarkable improvement in treatments these last decades, long term survival can be expected in more than 80% of childhood cancer patients. Unfortunately, cancer treatments can be harmful to the gonads and can affect reproductive and endocrine functions. While loss of fertility is a major concern for most patients, sperm cryopreservation should be offered to all pubertal male patients. For prepubertal boys, only the experimental option of testicular biopsy in order to cryopreserve testicular stem cells can be proposed.

Primary aims

- To cryopreserve testicular tissue of prepubertal patient receiving highly gonadotoxic oncological treatment.

Secondary aims

* To cryopreserve testicular tissue after failure of sperm cryopreservation in pubertal patient with high risk of infertility
* To create a database in order to record clinical and biological follow-up data
* To create a research biobank for future research projects

Multicentric study: HUG, CHUV, UKBB

Male Fertility Preservation Using Cryopreservation of Testicular Tissue Before Highly Gonadotoxic Cancer Treatment

The safety will be assessed by recording the number of complications of the procedure (e.g. bleeding, infection, testicular atrophy)

Comparison of biochemical markers (e.g., FSH; LH, AMH; Inhibin B, SHBG and testosterone) between patients who undergo testicular biopsy and controls

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Fertility in Young Adults Who Did (Not) Store Testicular Tissue Before a Treatment Leading to Fertility Problems	NCT04202094	Childhood Cance... Hematological D...	Physical examin... Scrotum ultraso... Blood sample Semen analysis	18 Years -	Universitair Ziekenhuis Brussel
Male Fertility Preservation Using Cryopreservation of Testicular Tissue Before Highly Gonadotoxic Cancer Treatment	NCT03180918	Childhood Cance... Fertility Disor...	testicular tiss...	3 Months - 18 Years	University Hospital, Geneva

Spots Global Cancer Trial Database for testicular tissue biopsy