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

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ClinicalTrials.gov Identifier: NCT04202094
Recruitment Status : Recruiting
First Posted : December 17, 2019
Last Update Posted : January 15, 2021
Sponsor:
Collaborator:
Vrije Universiteit Brussel
Information provided by (Responsible Party):
Ellen Goossens, Vrije Universiteit Brussel

Brief Summary:

This study is a prospective comparative interventional cohort study.

The study population consists 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. In order to preserve their fertility, these patients were proposed to store their testicular tissue at a young age. These young adults will be invited by e-mail/letter/telephone to evaluate their fertility status (Tanner stage, testicular volume, hormones, semen analysis) at adult age and at least one year after the last received gonadotoxic treatment.

A prospective analysis of data on their fertility status will be performed in order to identify differences between young adults who underwent a testicular tissue biopsy procedure (which is performed to harvest testicular tissue) at a young age and those who did not. The results of this prospective analysis will also be compared to the reproductive health of spontaneously conceived young adults.


Condition or disease Intervention/treatment Phase
Childhood Cancer Childhood Hematological Disease Diagnostic Test: Physical examination Diagnostic Test: Scrotum ultrasound Diagnostic Test: Blood sample Diagnostic Test: Semen analysis Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
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).

Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Follow-up of Fertility in Young Adults Who Did or Did Not Store Testicular Tissue Before Gonadotoxic Treatment for Fertility Preservation.
Actual Study Start Date : September 8, 2020
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Biopsy group
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 and who have chosen to undergo a testicular tissue biopsy procedure at a young age as a fertility preservation strategy.
Diagnostic Test: Physical 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 Test: Scrotum ultrasound
A scrotum ultrasound to measure the patients' testicular volume and to investigate potential abnormalities in the testicular parenchyma.

Diagnostic Test: Blood 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), 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.

Diagnostic Test: Semen analysis
A semen analysis to evaluate the ejaculate volumes, sperm concentration, sperm motility and sperm morphology. If sperm is found in the semen sample, an antisperm antibody test ((in)direct mixed anti-globulin reaction test) and a sperm DNA fragmentation test (TUNEL assay) 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.

Experimental: No biopsy group
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 and who have refused to undergo a testicular tissue biopsy procedure at a young age as a fertility preservation strategy.
Diagnostic Test: Physical 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 Test: Scrotum ultrasound
A scrotum ultrasound to measure the patients' testicular volume and to investigate potential abnormalities in the testicular parenchyma.

Diagnostic Test: Blood 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), 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.

Diagnostic Test: Semen analysis
A semen analysis to evaluate the ejaculate volumes, sperm concentration, sperm motility and sperm morphology. If sperm is found in the semen sample, an antisperm antibody test ((in)direct mixed anti-globulin reaction test) and a sperm DNA fragmentation test (TUNEL assay) 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.

No Intervention: Control group
Spontaneously conceived young adults whose data on reproductive health have already been published (Belva F et al., 2016/2017/2019).



Primary Outcome Measures :
  1. Impact of a testicular tissue biopsy procedure at a young age on the later fertility outcome. [ Time Frame: Once a year over a period of maximum 2 years ]
    The patients' fertility status (Tanner stage, testicular volume, hormones, semen analysis) will be evaluated once a year. 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 Outcome Measures :
  1. Impact of high-risk gonadotoxic treatment (with an ≥80% risk of later fertility problems) received during childhood on fertility restoration. [ Time Frame: 2 years ]
    The patients' spermatogenesis (with return of sperm production) will be evaluated through semen analysis once a year after cessation of gonadotoxic treatment.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Young adults (≥18 years).
  • Diagnosis of cancer or hematological disorder during childhood (<18 years).
  • High-risk gonadotoxic treatment (with an ≥80% risk of later fertility problems) during childhood.
  • At least one year after the last received gonadotoxic treatment.
  • Did or did not undergo a testicular tissue biopsy procedure at a young age as a fertility preservation strategy.

Exclusion Criteria:

  • Prepubertal patients and adolescents (<18 years).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04202094


Contacts
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Contact: Ellen Goossens, Prof. Dr. +3224774644 ellen.goossens@vub.be
Contact: Aude Braye, M. Sc. +3224774644 aude.braye@vub.be

Locations
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Belgium
Universitair Ziekenhuis Brussel Recruiting
Brussels, Flemish Brabant, Belgium, 1090
Contact: Veerle Vloeberghs, Dr.    +3224776699    veerle.vloeberghs@uzbrussel.be   
Contact: Ellen Van Moer    +3224776699    ellen.vanmoer@uzbrussel.be   
Sponsors and Collaborators
Universitair Ziekenhuis Brussel
Vrije Universiteit Brussel
Investigators
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Principal Investigator: Ellen Goossens, Prof. Dr. Vrije Universiteit Brussel
Publications:
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Responsible Party: Ellen Goossens, Head of research group BITE, Vrije Universiteit Brussel
ClinicalTrials.gov Identifier: NCT04202094    
Other Study ID Numbers: 2019-342
First Posted: December 17, 2019    Key Record Dates
Last Update Posted: January 15, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ellen Goossens, Vrije Universiteit Brussel:
Male fertility preservation
Testicular tissue biopsy
Male fertility status
Tanner stage
Testicular volume
Hormones
Semen analysis
Additional relevant MeSH terms:
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Hematologic Diseases