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Impact of Nuclear Human Sperm Quality on Embryo Development

NCT ID: NCT03320590

Last Updated: 2017-11-13

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-02

Study Completion Date

2020-01-01

Brief Summary

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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

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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.

Conditions

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Spermatic Parameters Embryonic Kinetics

Keywords

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Couple

Couple with female aged under 37 years

Time Lapse (material to observe embryonic development)

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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Time 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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

37 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Service Biologie de la reproduction-CECOS

UNKNOWN

Sponsor Role collaborator

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Florence BRUGNON

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

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CHU Clermont-Ferrand

Clermont-Ferrand, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Patrick LACARIN

Role: CONTACT

Phone: 04 73 75 11 95

Email: [email protected]

Facility Contacts

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Patrick LACARIN

Role: primary

Other Identifiers

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CHU-353

Identifier Type: -

Identifier Source: org_study_id