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

Universitair Ziekenhuis Brussel

Status: Invitation-only

Conditions: Hematological Disorders; Childhood Cancer

Treatments: Diagnostic Test: Physical examination; Diagnostic Test: Scrotum ultrasound; Diagnostic Test: Semen analysis; Diagnostic Test: Blood sample

Study type: Interventional

Funder types: Other

Identifiers

NCT04202094

2019-342

Details and patient eligibility

About

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.

Full description

See the subsequent protocol sections.

Enrollment: 50 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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50 participants in 3 patient groups

Biopsy group

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Semen analysis

Diagnostic Test: Blood sample

Diagnostic Test: Scrotum ultrasound

Diagnostic Test: Physical examination

No biopsy group

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Semen analysis

Diagnostic Test: Blood sample

Diagnostic Test: Scrotum ultrasound

Diagnostic Test: Physical examination

Control group

No Intervention group

Description:

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