Sperm Epigenome in Hodgkin Lymphoma
ConditionHodgkin Disease Lymphoma
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-45
SponsorRennes University Hospital
About this trial
Cancer treatments can have long-term effects on fertility. In men, scientific studies suggest that the process of sperm formation (spermatogenesis) may be disrupted even years after recovery, with potential consequences not only for fertility but also for the health of offspring. The effects of chemotherapy on sperm quality, particularly on DNA packaging (chromatin) and the epigenome, remain poorly understood. Therefore, further in-depth studies are needed to determine whether a history of cancer and chemotherapy treatment may impact the health of children fathered by young male survivors.
We therefore propose to conduct a clinical study aimed at better understanding the mechanisms by which chemotherapies affect spermatogenesis. The results could provide answers by identifying the effects of these drugs on the fertility of young male cancer patients in the long term and the sperm epigenome indicative of the health of the progeny.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Men aged 18 to 45 years
Diagnosed with Hodgkin lymphoma
Treatment-naïve to any cytotoxic therapy
Whose treatment regimen consists of 4 to 6 cycles of ABVD or BrECADD
Disqualifiers
Patient receiving abdominal radiotherapy
Trial design
Design model
Single group
Treatments tested in this trial
Additional semen samples
Other intervention5 additional semen samples : before chemotherapy, at month 6, 12, 18 and 24 after chemotherapy. Each sperm sample will be stored in liquid nitrogen and sent to Institut National de la Recherche Scientifique (INRS), Quebec, Canada for epigenetic analysis.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Epigenetic analysis in semen samplesExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Alterations in DNA methylation patterns in spermatozoa
Sperm analysis : Methyl-C Capture Sequencing (MCC-seq)
Time frame
Before chemotherapy, month 6, month 12, month 18, month 24 after chemotherapy2
Alterations of histone 3 H3k4me3 retention sites in spermatozoa
Sperm analysis : chromatin immunoprecipitation followed by sequencing (ChIP-seq)
Time frame
Before chemotherapy, month 6, month 12, month 18, month 24 after chemotherapySecondary outcomes
1
Spermogram exam
Spermogram examination
Time frame
Before chemotherapy, month 6, month 12, month 18, month 24 after chemotherapy2
Identification of known environmental factors impacting spermatogenesis
Patient questionnaire
Time frame
Month 24 after chemotherapySponsors and contacts
Click on the lead sponsor to view all of their trials.
Rennes University Hospital
Lead sponsor
Institut National de la Recherche Scientifique - Centre Armand Frappier Santé Biotechnologie
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: