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

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

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.

Study Overview

• Status: Unknown
• Conditions: Spermatic Parameters; Embryonic Kinetics
• Intervention / Treatment: Diagnostic test: Time Lapse (material to observe embryonic development)

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.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63003
    • Recruiting
    • CHU Clermont-Ferrand
    • Sub-Investigator: Solène VORILHON

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 37 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Couple with female aged under 37 years

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Couple; Couple with female aged under 37 years	Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
embryonic development kinetics	from 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	6 days after ICSI

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spermatic DNA fragmentation	the spermatic DNA fragmentation can be quantified by TUNEL method. The result will be expressed as a percentage of fragmented DNA	at day 1
Spermatic DNA Compaction	The 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	at day 1
Spermatic DNA Oxidation	The spermatic DNA oxidation will be quantified by 8-OHdG residue detection. The result will be expressed as a percentage of oxidized DNA	at day 1
Spermatic DNA methylation	Spermatic 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	at day 1

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Collaborators: Service Biologie de la reproduction-CECOS

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2017
• Primary Completion (Anticipated): July 1, 2019
• Study Completion (Anticipated): January 1, 2020

Study Registration Dates

• First Submitted: October 2, 2017
• First Submitted That Met QC Criteria: October 19, 2017
• First Posted (Actual): October 25, 2017

Study Record Updates

• Last Update Posted (Actual): November 13, 2017
• Last Update Submitted That Met QC Criteria: November 9, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Spermatic nuclear quality; intracytoplasmic sperm injection (ICSI); Time lapse Primovision; Embryonic kinetics
• Other Study ID Numbers: CHU-353

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No