Fertility in Young Adults Who Did (Not) Store Testicular Tissue Before a Treatment Leading to Fertility Problems.
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04202094 |
Recruitment Status :
Recruiting
First Posted : December 17, 2019
Last Update Posted : May 26, 2022
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |

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 |

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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).

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
Contact: Ellen Goossens, Prof. Dr. | +3224774644 | ellen.goossens@vub.be | |
Contact: Aude Braye, M. Sc. | +3224774644 | aude.braye@vub.be |
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 |
Principal Investigator: | Ellen Goossens, Prof. Dr. | Vrije Universiteit Brussel |
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: | May 26, 2022 |
Last Verified: | May 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Male fertility preservation Testicular tissue biopsy Male fertility status Tanner stage |
Testicular volume Hormones Semen analysis |
Hematologic Diseases |