Childhood Cancer, Hematological Disorders
Conditions
Keywords
Male fertility preservation, Testicular tissue biopsy, Male fertility status, Tanner stage, Testicular volume, Hormones, Semen analysis
Brief summary
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 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 fertility status with the reproductive health of spontaneously conceived young adults.
Detailed description
See the subsequent protocol sections.
Interventions
DIAGNOSTIC_TESTPhysical examination
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).
DIAGNOSTIC_TESTScrotum ultrasound
A scrotum ultrasound to measure the patients' testicular volume and to investigate potential abnormalities in the testicular parenchyma.
DIAGNOSTIC_TESTBlood sample
A morning blood sample to evaluate the serum levels of luteinizing hormone (LH), follicle-stimulating hormone (FSH), testosterone (T), estradiol (E2), inhibin B (INHB) and insulin-like peptide 3 (INSL3). 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.
DIAGNOSTIC_TESTSemen analysis
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.
Sponsors
Universitair Ziekenhuis Brussel
Vrije Universiteit Brussel
Study design
Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
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).
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* young adult men (≥18 years) * diagnosis of cancer or hematological disorder during childhood (\<18 years) * high-risk gonadotoxic treatment received during childhood * at least one year after the last received genotoxic treatment * did/did not undergo a testicular biopsy procedure at a young age for fertility preservation
Exclusion criteria
\- prepubertal patients and adolescents (\<18 years)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Impact of childhood gonadotoxic treatment on fertility status | at baseline and in 1 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Impact of testicular biopsy procedure (performed at a young age) on fertility status | at baseline and in 1 year | 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. |
Countries
Belgium
Contacts
PRINCIPAL_INVESTIGATOREllen Goossens, Prof. Dr.
Vrije Universiteit Brussel
Outcome results
None listed