Sperm Epigenome in Hodgkin Lymphoma

NCT07449832 | Not Yet Recruiting

• 1 other identifier: 35RC24_9822_SPELH
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hodgkin Disease Lymphoma

Keywords

epigenetic; chemotherapy; male gametes

Outcome Measures

Primary Outcomes (2)

• Alterations in DNA methylation patterns in spermatozoa

  Sperm analysis : Methyl-C Capture Sequencing (MCC-seq)

  Before chemotherapy, month 6, month 12, month 18, month 24 after chemotherapy

• Alterations of histone 3 H3k4me3 retention sites in spermatozoa

  Sperm analysis : chromatin immunoprecipitation followed by sequencing (ChIP-seq)

  Before chemotherapy, month 6, month 12, month 18, month 24 after chemotherapy

Secondary Outcomes (2)

• Spermogram exam

  Before chemotherapy, month 6, month 12, month 18, month 24 after chemotherapy

• Identification of known environmental factors impacting spermatogenesis

  Month 24 after chemotherapy

Study Arms (1)

Epigenetic analysis in semen samples

EXPERIMENTAL

30 men with hodgkin lymphoma will be followed during 24 months in order to search epigenetic modifications in male gametes

Other: Additional semen samples

Interventions

Additional semen samples OTHER

5 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.

Epigenetic analysis in semen samples

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• Beneficiaries of the French social security system
• Not opposed to participating in research

You may not qualify if:

• Patient receiving abdominal radiotherapy

Sponsors & Collaborators

• Rennes University Hospital: lead
• Institut National de la Recherche Scientifique - Centre Armand Frappier Santé Biotechnologie: collaborator

Study Sites (1)

Centre Hospitalier Universitaire de Rennes

Rennes, 35033, France

Location

Study Officials

• Géraldine DELBES, PhD

  Institut National de la Recherche Scientifique (INRS), Québec, Canada

  STUDY CHAIR

Central Study Contacts

Tony MARCHAND, MD, PhD

CONTACT

02 99 28 42 91; tony.marchand@chu-rennes.fr

Célia RAVEL, MD, PhD

CONTACT

02 99 26 59 16; celia.ravel@chu-rennes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: March 4, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030
• Last Updated: May 14, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)