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

NCT04202094 | Enrolling By Invitation

• 1 other identifier: 2019-342
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Childhood Cancer; Hematological Disorders

Keywords

Male fertility preservation; Testicular tissue biopsy; Male fertility status; Tanner stage; Testicular volume; Hormones; Semen analysis

Outcome Measures

Primary Outcomes (1)

• Impact of childhood gonadotoxic treatment on fertility status

  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.

  at baseline and in 1 year

Secondary Outcomes (1)

• Impact of testicular biopsy procedure (performed at a young age) on fertility status

  at baseline and in 1 year

Study Arms (3)

Biopsy group

EXPERIMENTAL

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.

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

No biopsy group

EXPERIMENTAL

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.

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

Control group

NO INTERVENTION

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

Interventions

Physical examination DIAGNOSTIC_TEST

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).

Biopsy group; No biopsy group

Scrotum ultrasound DIAGNOSTIC_TEST

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

Biopsy group; No biopsy group

Blood sample DIAGNOSTIC_TEST

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.

Biopsy group; No biopsy group

Semen analysis DIAGNOSTIC_TEST

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.

Biopsy group; No biopsy group

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- prepubertal patients and adolescents (\<18 years)

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead
• Vrije Universiteit Brussel: collaborator

Study Sites (1)

Universitair Ziekenhuis Brussel

Brussels, 1090, Belgium

Location

Related Publications (4)

• Belva F, Bonduelle M, Roelants M, Michielsen D, Van Steirteghem A, Verheyen G, Tournaye H. Semen quality of young adult ICSI offspring: the first results. Hum Reprod. 2016 Dec;31(12):2811-2820. doi: 10.1093/humrep/dew245. Epub 2016 Oct 5.

  PMID: 27707840 BACKGROUND

• Belva F, Roelants M, De Schepper J, Van Steirteghem A, Tournaye H, Bonduelle M. Reproductive hormones of ICSI-conceived young adult men: the first results. Hum Reprod. 2017 Feb;32(2):439-446. doi: 10.1093/humrep/dew324. Epub 2016 Dec 21.

  PMID: 28007789 BACKGROUND

• Belva F, Bonduelle M, Tournaye H. Endocrine and reproductive profile of boys and young adults conceived after ICSI. Curr Opin Obstet Gynecol. 2019 Jun;31(3):163-169. doi: 10.1097/GCO.0000000000000538.

  PMID: 30870183 BACKGROUND

• Delgouffe E, Braye A, Vloeberghs V, Mateizel I, Ernst C, Ferster A, Devalck C, Tournaye H, Gies I, Goossens E. Spermatogenesis after gonadotoxic childhood treatment: follow-up of 12 patients. Hum Reprod Open. 2023 Jul 31;2023(3):hoad029. doi: 10.1093/hropen/hoad029. eCollection 2023.

  PMID: 37547664 RESULT

MeSH Terms

Conditions

Neoplasms; Hematologic Diseases

Interventions

Physical Examination; Blood Specimen Collection; Semen Analysis

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Clinical Laboratory Techniques; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Ellen Goossens, Prof. Dr.

  Vrije Universiteit Brussel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of research group BITE

Model Details: 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).

Study Record Dates

• First Submitted: December 6, 2019
• First Posted: December 17, 2019
• Study Start: September 8, 2020
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)