Clinical trial NCT03320590: Impact of Nuclear Human Sperm Quality on Embryo Development
Official title: Impact of Nuclear Quality of Human Sperm on Embryonic Development Kinetics Evaluated by Time Lapse Primovision®
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Spermatic Parameters
Embryonic Kinetics
Keywords: Time lapse Primovision
Spermatic nuclear quality
intracytoplasmic sperm injection (ICSI)
Embryonic kinetics
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Service Biologie de la reproduction-CECOS
First posted: 2017-10-25
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Couple with female aged under 37 years

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.

Eligibility criteria: 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

Primary outcomes:
measure: embryonic development kinetics
timeFrame: 6 days after ICSI
Secondary outcomes:
measure: Spermatic DNA fragmentation
timeFrame: at day 1
measure: Spermatic DNA Compaction
timeFrame: at day 1
measure: Spermatic DNA Oxidation
timeFrame: at day 1
measure: Spermatic DNA methylation
timeFrame: at day 1
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Florence BRUGNON
role: PRINCIPAL_INVESTIGATOR
References: