NCT04715828|Unknown
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Sponsor study identifier
observational
200
1 country
1
Study Start
January 1, 2018
Actual (reported)Primary Completion
January 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1, 2018
Actual (reported)January 15, 2021
Actual (reported)January 20, 2021
Actual (reported)January 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
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)
Fresh semen treated without irradiation before cryopreservation
cryopreserved semen without irradiation (n=60)
Pelvis scanning : acute irradiation (1 or 2 second) using low dose (n=30),
Bone scintigraphy : long irradiation (3h) using low dose (n=30),
Radioactive Iodine 131 therapy (RAT) applied for thyroid cancer : long irradiation (3h) using medium dose (n=60),
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
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
CHU de Clermont-Ferrand
Clermont-Ferrand, 63000, France
Hanae PONS-REJRAJI, PhD
University Hospital, Clermont-Ferrand
First Submitted
January 15, 2021
First Posted
January 20, 2021
Study Start
January 1, 2018
Actual (reported)Primary Completion
January 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
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
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Study Completion
January 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 20, 2021
Record last verified: 2021-01
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Source: ClinicalTrials.gov.
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