Impact of Nuclear Human Sperm Quality on Embryo Development

Spermatic Parameters Clinical Trial

— PRIMOSPERMO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03320590
• Other study ID #: CHU-353
• Status: Recruiting
• Phase: N/A
• First received: October 2, 2017
• Last updated: November 9, 2017
• Start date: January 2, 2017
• Est. completion date: January 1, 2020

Study information

• Verified date: November 2017
• Source: University Hospital, Clermont-Ferrand
• Contact: Patrick LACARIN
• Phone: 04 73 75 11 95
• Email: placarin[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 1, 2020
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 37 Years

Eligibility

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

Related Conditions & MeSH terms

• Embryonic Kinetics
• Spermatic Parameters

Intervention

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.

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	Service Biologie de la reproduction-CECOS

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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