Impact of Ionizing Treatment on the Nuclear Structure of Human Spermatozoa.
NCT ID: NCT04715828
Last Updated: 2021-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
200 participants
OBSERVATIONAL
2018-01-01
2022-01-01
Brief Summary
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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.
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Detailed Description
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The secondary objectives are :
* to measure RAT impact on sperm parameters (vitality, motility and morphology)
* to measure the impact of cryopreservation on chromatin organisation and nucleus morphology
* to evaluate RAT impact on human sperm cells in comparison with cryopreservation
* to evaluate the impact of different doses and types of irradiation on human sperm cells
* to establish relations between potential alterations of standards sperm parameters (vitality, motility and morphology) and nuclear sperm parameters (DNA fragmentation and oxidation, chromatin condensation and organisation, nucleus morphology and STL.
Our final goal is to provide a significant improvement of men fertility diagnosis and optimize our fertility preservation practices.
To this end, we will expose ejaculated human spermatozoa (n = 90) at different (low and moderate) doses of gamma or X photons to mimic gonads irradiation. Absorbed doses by the samples were calculated using the GATE Monte Carlo platform (version 8.2). Experiment geometry settings were modelled as three dimension voxelized volumes inside the software by assigning a shape, size, distance and density for all the volumes created. All measurements will be made on surplus samples from men undergoing routine semen analysis at the Center for Reproductive Medicine, after receiving their written informed consent. Semen samples are collected and subdivided into 3 arms to analyse sperm quality after:
* irradiation exposure (3 conditions);
* a freezing- thawing cycle;
* fresh state: negative control without treatment.
Before (fresh state) and after each treatment we will analyse:
* standard semen parameters (vitality, motility and morphology) in accordance with WHO, 2010;
* STL using Flow FISH, q-PCR and q-FISH;
* chromatin condensation (chromomycin A3);
* DNA oxidization (8-OHdG residues);
* DNA fragmentation (TUNEL);
* 3D nucleus structure using 3D bio-imaging.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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control arm "fresh"
Fresh semen treated without irradiation before cryopreservation
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).
control arm "cryopreserved"
cryopreserved semen without irradiation (n=60)
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).
acute irradiation at low dose
Pelvis scanning : acute irradiation (1 or 2 second) using low dose (n=30),
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
long irradiation at low dose
Bone scintigraphy : long irradiation (3h) using low dose (n=30),
Long and low irradiation
sperm sample will be exposed to gamma radiation by adding a solution of Tc99m for 3 hours.
long irradiation at medium dose
Radioactive Iodine 131 therapy (RAT) applied for thyroid cancer : long irradiation (3h) using medium dose (n=60),
Long and medium irradiation
sperm sample will be exposed to gamma radiation by adding a solution of I131 for 3 hours
Interventions
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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).
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
Long and low irradiation
sperm sample will be exposed to gamma radiation by adding a solution of Tc99m for 3 hours.
Long and medium irradiation
sperm sample will be exposed to gamma radiation by adding a solution of I131 for 3 hours
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
18 Years
45 Years
MALE
No
Sponsors
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Agence de La Biomédecine
OTHER_GOV
University Hospital, Clermont-Ferrand
OTHER
Responsible Party
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Principal Investigators
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Hanae PONS-REJRAJI, PhD
Role: STUDY_CHAIR
CHU de Clermont-Ferrand
Locations
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CHU de Clermont-Ferrand
Clermont-Ferrand, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2020 PONS-REJRAJI
Identifier Type: -
Identifier Source: org_study_id
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