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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05461079
Other study ID # RME12072017
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 1, 2017
Est. completion date December 31, 2023

Study information

Verified date March 2024
Source University of Basel
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Testicular dysgenesis syndrome (TDS) is known to cause epigenetic abnormalities in spermatozoa. Anogenital distance (AGD) is considered to be a suitable clinical marker of TDS, but the direct link between AGD and epigenetic abnormalities is still missing. Infertile men (n=10) presenting with shortened AGD and a control group of normal semen donors (n=10) with normal AGD will then be asked to provide one semen sample each. Using a flow cytometer and sorter (FACS) their spermatozoa will be sorted into populations of spermatozoa with/without DNA fragmentation or with/without chromatin decondensation. These sorted populations of spermatozoa will then be examined for differences in epigenetic imprinting differences using whole genome expression analysis. Whereas the sorting of spermatozoa will be carried out in Basel, the epigenetic analysis will be carried at the University of Geneva.


Description:

A subset of 10 men with shortened AGD (together with a control group of 10 fertile donors with normal AGD) will be asked to provide up to three semen samples, each of which then will be sorted with FACS into subpopulations with/without DNA fragmentation and into subpopulations with/without chromatin decondensation. Spermatozoa with fragmented DNA will be separated through FACS-sorting of spermatozoa with intact DNA using the YoPro 1-dye, which has been shown to correlate significantly with the degree of DNA fragmentation in the nuclei of sperm. In addition, spermatozoa with abnormal chromatin remodelling will be separated through sorting from spermatozoa with condensed chromatin using the fluorochrome chromomycin A3 (CMA3), which competes for protamin for binding to the minor groove of DNA thereby correlating with the persistence of histones in the sperm nuclei. Pilot experiments have demonstrated the highly significant and close correlation of CMA3 with anilin blue staining. Anilin blue staining is not suitable for the sorting experiment, because it requires fixation of the spermatozoa. Sorting based on CMA3 can be carried out with living spermatozoa. The sorted and anonymized samples will then be sent frozen in dry ice to a laboratory at the University of Geneva for the assessment of differences in the epigenetic imprinting of the DNA using whole genome expression studies.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date December 31, 2023
Est. primary completion date January 30, 2021
Accepts healthy volunteers
Gender Male
Age group 20 Years to 55 Years
Eligibility Inclusion Criteria: - infertile men with known anogenital distance Exclusion Criteria: - sperm concentration must be more than 15 million/ml to allow appropriate sorting with flow cytometry...

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
obtention of up to three semen samples
sorting of spermatozoa with flow cytometry. In the presence of insufficient numbers of spermatozoa after sorting (<15 mill), up to three semen samples will be collected.

Locations

Country Name City State
Switzerland Christian De Geyter Basel

Sponsors (2)

Lead Sponsor Collaborator
University of Basel University of Geneva, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary anogenital distance and epigenetics number of differentially methylated transposable regulatory sequences in the genome of sorted spermatozoa. 6 months
Secondary sperm phenotype 1 based on conventional semen analysis: concentration of spermatozoa (in mill/ml). 6 months
Secondary sperm phenotype 2 based on conventional semen analysis: progressive motility (in %). 6 months
Secondary sperm phenotype 3 based on conventional semen analysis: normal morphology (in %), staining). 6 months
Secondary sperm phenotype 4 chromatin decondensation (as given by % of CMA3 staining). 6 months
Secondary sperm phenotype 5 DNA fragmentation (% of YoPro 1-staining). 6 months
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