Impact of Ionizing Treatment on the Nuclear Structure of Human Spermatozoa.
1 other identifier
observational
200
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2018
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2018
CompletedFirst Submitted
Initial submission to the registry
January 15, 2021
CompletedFirst Posted
Study publicly available on registry
January 20, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2022
CompletedJanuary 20, 2021
January 1, 2021
4 years
January 15, 2021
January 15, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To measure in vitro the impact of an ionizing radiation treatment on sperm nuclear quality and in particular the size of telomeres.
To achieve this goal, we will expose human sperm to an irradiation dose of I131 to mimic the irradiation of gonads and sperm. Reliquat of semen will be cryopreserved (control condition). After thawing, the same sample will be subdivised into 2 groups in order to analyze the sperm quality : * After an irradiation dose of I131 * After a cryopreservation
01/01/2018-01/01/2022
Secondary Outcomes (6)
To measure in vitro the impact of an irradiation dose of I131 on sperm nuclear quality, notably on STL.
01/01/2018-01/01/2022
to measure RAT impact on sperm parameters (vitality, motility and morphology)
01/01/2018-01/01/2022
To measure in vitro the impact of cryopreservation on sperm nuclear quality, notably on STL, chromatin organisation and nucleus morphology
01/01/2018-01/01/2022
to evaluate RAT impact on human sperm cells in comparison with cryopreservation
01/01/2018-01/01/2022
to evaluate the impact of different doses and types of irradiation on human sperm cells
01/01/2018-01/01/2022
- +1 more secondary outcomes
Study Arms (5)
control arm "fresh"
Fresh semen treated without irradiation before cryopreservation
control arm "cryopreserved"
cryopreserved semen without irradiation (n=60)
acute irradiation at low dose
Pelvis scanning : acute irradiation (1 or 2 second) using low dose (n=30),
long irradiation at low dose
Bone scintigraphy : long irradiation (3h) using low dose (n=30),
long irradiation at medium dose
Radioactive Iodine 131 therapy (RAT) applied for thyroid cancer : long irradiation (3h) using medium dose (n=60),
Interventions
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).
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
sperm sample will be exposed to gamma radiation by adding a solution of Tc99m for 3 hours.
sperm sample will be exposed to gamma radiation by adding a solution of I131 for 3 hours
Eligibility Criteria
All measurements are made on surplus samples from men undergoing routine semen analysis at the Center for Reproductive Medicine, after receiving their written informed consent
You may qualify if:
- Man less than 45 years
- Man undergoing routine semen analysis at the Center for Reproductive Medicine, accepting the research protocol and signing the associated consent will be included in the protocol without distinction of physical criteria.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Clermont-Ferrandlead
- Agence de La Biomédecinecollaborator
Study Sites (1)
CHU de Clermont-Ferrand
Clermont-Ferrand, 63000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Hanae PONS-REJRAJI, PhD
CHU de Clermont-Ferrand
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 15, 2021
First Posted
January 20, 2021
Study Start
January 1, 2018
Primary Completion
January 1, 2022
Study Completion
January 1, 2022
Last Updated
January 20, 2021
Record last verified: 2021-01