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Evaluation of pubertal and hormone development in boys who stored testicular tissue for fertility preservation before a treatment possibly leading to later fertility problems

Follow-up of pubertal and endocrine development in boys who stored testicular tissue for fertility preservation before high-risk gonadotoxic treatment

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN13057463
Enrollment
100
Registered
2020-06-02
Start date
2018-01-01
Completion date
Unknown
Last updated
2026-02-16

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

Conditions

Childhood cancer, childhood hematological disease Nutritional, Metabolic, Endocrine

Interventions

Current interventions as of 21/01/2026: The study population consists of pre- and peripubertal boys (<18 years) diagnosed at the Universitair Ziekenhuis Brussel (UZ Brussel) or at the Hôpital Universi

Sponsors

Universitair Ziekenhuis Brussel
Lead Sponsor
Vrije Universiteit Brussel
Collaborator

Eligibility

Sex/Gender
Male
Age
0 Years to 18 Years

Inclusion criteria

Inclusion criteria: Current inclusion criteria as of 11/01/2021: 1. Pre- and peripubertal boys (<18 years) who do not yet produce mature spermatozoa 2. Diagnosis of childhood cancer or childhood hematological disorders (<18 years) at the Universitair Ziekenhuis Brussel or the Hôpital Universitaire Des Enfants Reine Fabiola 3. High-risk gonadotoxic treatment (with an =80% risk of later fertility problems) 4. Did or did not undergo a testicular tissue biopsy procedure at a young age as a fertility preservation strategy _____ Previous inclusion criteria: 1. Pre- and peripubertal boys (<18 years) who do not yet produce mature spermatozoa 2. Diagnosis of childhood cancer or childhood hematological disorders (<18 years) at the Universitair Ziekenhuis Brussel 3. High-risk gonadotoxic treatment (with an =80% risk of later fertility problems) 4. Did or did not undergo a testicular tissue biopsy procedure at a young age as a fertility preservation strategy

Exclusion criteria

Exclusion criteria: 1. Diagnosis of testicular cancer

Design outcomes

Primary

MeasureTime frame
Current primary outcome measure as of 21/01/2026: Impact of a testicular tissue biopsy procedure performed at a young age on pubertal and endocrine development using the following measurements at diagnosis and yearly until the age of 18 years (starting from the end of the gonadotoxic treatment): 1. A physical examination to measure the patient’s weight, height, body mass index, blood pressure, and testicular volume using a Prader orchidometer and to determine the patient’s Tanner stage (scoring of patient’s pubertal maturation) 2. A scrotum ultrasound to measure the patient’s testicular volume and to investigate potential abnormalities in the testicular parenchyma 3. A morning blood sample to evaluate the serum levels of luteinizing hormone (LH), follicle-stimulating hormone (FSH), testosterone (T), estradiol (E2), inhibin B (INHB), anti-Müllerian hormone (AMH), and insulin-like peptide 3 (INSL3), with mention of possible hormonal substitution treatment (start, duration, and dose prescribed) 4. An X-ray of the left hand and wrist to determine the patient’s bone age Previous primary outcome measure as of 11/01/2021: Impact of a testicular tissue biopsy procedure performed at a young age on pubertal and endocrine development using the following measurements at diagnosis and yearly until the age of 18 years (starting from the end of the gonadotoxic treatment): 1. A physical examination to measure the patient’s weight, height, body mass index, blood pressure, and testicular volume using a Prader orchidometer and to determine the patient’s Tanner stage (scoring of patient’s pubertal maturation) 2. A scrotum ultrasound to measure the patient’s testicular volume and to investigate potential abnormalities in the testicular parenchyma 3. A morning blood sample to evaluate the serum levels of luteinizing hormone (LH), follicle-stimulating hormone (FSH), testosterone (T), estradiol (E2), inhibin B (INHB), anti-Müllerian hormone (AMH), thyroid-stimulating hormone (TSH), fre

Secondary

MeasureTime frame
Current secondary outcome measures as of 11/01/2021: 1. The patient's medical background: the diagnosis and the patient’s age at the time of diagnosis, the type of treatment received with mention of the cumulative dose (chemotherapy, radiotherapy, total body irradiation, bone marrow transplantation, type and frequency of surgery…) 2. Whether or not a testicular tissue biopsy procedure has been performed at a young age with mention of the testis portion biopsied (orchiectomy, hemi-orchiectomy, or smaller portion), the site of biopsy (left, right or bilateral), the patient’s age at the time of biopsy and the reason why the patient and his parents accepted or refused testicular tissue banking _____ Previous secondary outcome measures: 1. The patient's medical background: the diagnosis and the patient’s age at time of diagnosis, the type of treatment received with mention of the cumulative dose (chemotherapy, radiotherapy, total body irradiation, bone marrow transplantation, type and frequency of surgery, …) 2. Whether or not a testicular tissue biopsy procedure has been performed at a young age with mention of the testis portion biopsied (orchiectomy, hemi-orchiectomy or smaller portion), the site of biopsy (left, right or bilateral), the patient’s age at time of biopsy and the reason why the patient and his parents accepted or refused testicular tissue banking

Countries

Belgium

Contacts

Public ContactInge Gies
inge.gies@uzbrussel.be+32 24744180

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 19, 2026