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Impact of Nuclear Human Sperm Quality on Embryo Development (PRIMOSPERMO)

U

University Hospital, Clermont-Ferrand

Status

Unknown

Conditions

Spermatic Parameters
Embryonic Kinetics

Treatments

Diagnostic Test: Time Lapse (material to observe embryonic development)

Study type

Observational

Funder types

Other

Identifiers

NCT03320590
CHU-353

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 estimated patients

Sex

All

Ages

18 to 37 years old

Volunteers

No Healthy Volunteers

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

Trial design

200 participants in 1 patient group

Couple
Description:
Couple with female aged under 37 years
Treatment:
Diagnostic Test: Time Lapse (material to observe embryonic development)

Trial contacts and locations

1

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Central trial contact

Patrick LACARIN

Data sourced from clinicaltrials.gov

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