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Impact of Nuclear Human Sperm Quality on Embryo Development

Impact of Nuclear Quality of Human Sperm on Embryonic Development Kinetics Evaluated by Time Lapse Primovision®

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03320590
Acronym
PRIMOSPERMO
Enrollment
200
Registered
2017-10-25
Start date
2017-01-02
Completion date
2020-01-01
Last updated
2017-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Embryonic Kinetics, Spermatic Parameters

Keywords

Time lapse Primovision, Spermatic nuclear quality, intracytoplasmic sperm injection (ICSI), Embryonic kinetics

Brief summary

To date, none study shows the impact of human spermatozoa nuclear alteration on embryonic development kinetic with morpho-kinetics tools. In this study, Investigator analyze the possible influence of sperm nuclear quality on embryonic development kinetics. Moreover, Investigator will evaluate possible new sperm biomarkers and try to better understand the pathophysiology of male infertility.

Detailed description

In recent years, there has clearly been a significant decline in male fertility in industrialized countries, particularly sperm quality. Furthermore, it is known that the quality of sperm DNA affects embryonic development and pregnancy outcomes. However, few elements are known about the effects of spermatozoa nuclear alterations on the embryonic development kinetics. Thus, the aim of this study is to analyze the possible influence of sperm nuclear quality on the embryonic development kinetics. In order to answer this question, Investigator will study the spermatozoa quality of patients whose torque is supported by ICSI. On these spermatozoa, Investigator will analyze DNA fragmentation, oxidation by measuring the 8-OHdG residues, chromatin compaction and nuclear methylation degree. This will allow to determine the spermatic nuclear parameters in relation to an ICSI fertilization rate (normal\> 60%) and a good blastocyst rate (≥ B3 in the Gardner classification). And finally, by this study, Investigator will probably find new biological markers spermatic. Moreover, the data will help to better understand the physiopathology of male infertility.

Interventions

DIAGNOSTIC_TESTTime Lapse (material to observe embryonic development)

The embryonic kinetics are recorded by Time lapse Primovision™ (Vitrolife). These kinetic parameters are analysed and annotated by only one person with expertise in this technology.

Sponsors

Service Biologie de la reproduction-CECOS
CollaboratorUNKNOWN
University Hospital, Clermont-Ferrand
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 37 Years
Healthy volunteers
No

Inclusion criteria

* Couple whose wife is younger than 37 * First or second ICSI attempt at Clermont-Ferrand University hospital * Spermatozoa's concentration after Percoll gradients discontinuous technique is greater than or equal 0.5 million of spermatozoa * Number of oocytes injected in ICSI greater than or equal to 6

Exclusion criteria

* If ICSI performed with testicular, epididymal or frozen spermatozoa * If one or both of the couple take antioxidant treatments

Design outcomes

Primary

MeasureTime frameDescription
embryonic development kinetics6 days after ICSIfrom the records obtained with Time Lapse Primovision, we will be able to determine the precise times of embryonic development to obtain a good quality blastocyst and finally a pregnancy

Secondary

MeasureTime frameDescription
Spermatic DNA fragmentationat day 1the spermatic DNA fragmentation can be quantified by TUNEL method. The result will be expressed as a percentage of fragmented DNA
Spermatic DNA Compactionat day 1The spermatic DNA Compaction will be determinated by chromomycine A3 labelling (CMA3). A sperm is good when il has at least 30% of positive spermatozoa to CMA3 assay
Spermatic DNA Oxidationat day 1The spermatic DNA oxidation will be quantified by 8-OHdG residue detection. The result will be expressed as a percentage of oxidized DNA
Spermatic DNA methylationat day 1Spermatic DNA methylation quantified by 5-mC residue immune-detection by Elisa assay. In control population, a rate of 13% of methylated spermatozoa is considered as normal

Countries

France

Contacts

Primary ContactPatrick LACARIN
placarin@chu-clermontferrand.fr04 73 75 11 95

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026