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®
1 other identifier
observational
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2017
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 2, 2017
CompletedFirst Submitted
Initial submission to the registry
October 2, 2017
CompletedFirst Posted
Study publicly available on registry
October 25, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2020
CompletedNovember 13, 2017
November 1, 2017
2.5 years
October 2, 2017
November 9, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Spermatic DNA fragmentation
at day 1
Spermatic DNA Compaction
at day 1
Spermatic DNA Oxidation
at day 1
Spermatic DNA methylation
at day 1
Study Arms (1)
Couple
Couple with female aged under 37 years
Interventions
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.
Eligibility Criteria
Couple with female aged under 37 years
You may qualify if:
- 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
You may not qualify if:
- If ICSI performed with testicular, epididymal or frozen spermatozoa
- If one or both of the couple take antioxidant treatments
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Clermont-Ferrand
Clermont-Ferrand, 63003, France
Study Officials
- PRINCIPAL INVESTIGATOR
Florence BRUGNON
University Hospital, Clermont-Ferrand
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 2, 2017
First Posted
October 25, 2017
Study Start
January 2, 2017
Primary Completion
July 1, 2019
Study Completion
January 1, 2020
Last Updated
November 13, 2017
Record last verified: 2017-11