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Impact of Ionizing Treatment on the Nuclear Structure of Human Spermatozoa.

NCT04715828 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2021-01-20

No results posted yet for this study

Summary

Differentiated thyroid cancer is the third cause of cancer in young men of childbearing age. Its treatment by irradiation with Radioactive Iodine 131 therapy (RAT) could alter spermatogenesis and result in azoospermia and permanent infertility. A preventive gametes cryopreservation was recommended before RAT, but without mentioning a period of teratogenic risk transmissible to the offspring. To date, RAT impact on human sperm nucleus is poorly known or even unknown, notably on telomere length.

Our objective is to define RAT effects on human sperm nucleus by in vitro irradiation exposure of human spermatozoa to mimicking that of the gonads in the context of irradiation with iodine131 used for thyroid cancer. We will analyze standard sperm parameters, major DNA alterations and telomere length using molecular and cellular assays. Nucleus morphology and chromatin organization will also be analyzed using 3D bio-imaging. This study will permit to optimize the indications for the preservation of fertility.

Conditions

  • Sperm Preservation
  • Irradiated Semen

Interventions

OTHER

Cryopreserved semen

sperm will be frozen in Cryosperm® cryoprotectant medium (Origio). The samples will be packaged in previously identified high security straws (Cryobiosystem). Slow freezing of the straws will be carried out using the Nanodigicool® programmable device (Cryobiosystem).

OTHER

Acute and low irradiation

sperm sample will be placed on the scanner's processing table to be exposed for 1 to 2 seconds. Several dose levels will then be made in order to limit the value of 17 mGy

OTHER

Long and low irradiation

sperm sample will be exposed to gamma radiation by adding a solution of Tc99m for 3 hours.

OTHER

Long and medium irradiation

sperm sample will be exposed to gamma radiation by adding a solution of I131 for 3 hours

Sponsors & Collaborators

  • Agence de La Biomédecine

    collaborator OTHER_GOV

  • University Hospital, Clermont-Ferrand

    lead OTHER

Principal Investigators

  • Hanae PONS-REJRAJI, PhD · CHU de Clermont-Ferrand

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-01
Primary Completion
2022-01-01
Completion
2022-01-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04715828 on ClinicalTrials.gov