Spermatic ParametersPRIMOSPERMONCT03320590
Impact of Nuclear Human Sperm Quality on Embryo Development
An observational study of Spermatic Parameters and Embryonic Kinetics, run by University Hospital, Clermont-Ferrand at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 37 years
- Conditions the study is for
- Spermatic Parameters, Embryonic Kinetics
- What is being tested?
- Time Lapse (material to observe embryonic development)
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jan 2017to 1 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 37 years
- All sexes
- No healthy volunteers
- Adult
Study population: Couple with female aged under 37 years
Who may be able to join
- 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
Who cannot join
- If ICSI performed with testicular, epididymal or frozen spermatozoa
- If one or both of the couple take antioxidant treatments
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand, 63003
Patrick LACARIN, 04 73 75 11 95, placarin@chu-clermontferrand.fr
Florence BRUGNON
About this study
Official title: 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.
Read the 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.
- Conditions
- Spermatic Parameters, Embryonic Kinetics
- Being tested
- Time Lapse (material to observe embryonic development)
- Keywords
- Time lapse Primovision, Spermatic nuclear quality, intracytoplasmic sperm injection (ICSI), Embryonic kinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time Lapse (material to observe embryonic development)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.
| Study group | Role | What they receive |
|---|---|---|
| Couple | Couple with female aged under 37 years Receives: Diagnostic Test: Time Lapse (material to observe embryonic development) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 days after ICSI
Secondary outcomes (4)
Spermatic DNA fragmentation
the spermatic DNA fragmentation can be quantified by TUNEL method. The result will be expressed as a percentage of fragmented DNA
Measured: 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
Measured: 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
Measured: 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
Measured: at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2017
- Study start2 Jan 2017
- Primary completion1 Jul 2019 (estimated)
- Study completion1 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spermatic ParametersStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Service Biologie de la reproduction-CECOS
- Responsible party
- Sponsor
- Investigators
- Florence BRUGNON, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03320590
- Sponsor's protocol ID
- CHU-353
- Acronym
- PRIMOSPERMO
- Status last verified
- Nov 2017
- First submitted
- 2 Oct 2017
- Last updated
- 13 Nov 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Nuclear Quality of Human Sperm on Embryonic Development Kinetics Evaluated by Time Lapse Primovision®
- ClinicalTrials.gov ID
- NCT03320590
- Acronym / sponsor ID
- PRIMOSPERMO / CHU-353
- Conditions
- Spermatic Parameters, Embryonic Kinetics
- Keywords
- Time lapse Primovision, Spermatic nuclear quality, intracytoplasmic sperm injection (ICSI), Embryonic kinetics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Service Biologie de la reproduction-CECOS
- Study start
- 2 Jan 2017 (actual)
- Primary completion
- 1 Jul 2019 (estimated)
- Study completion
- 1 Jan 2020 (estimated)
- First posted
- 25 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Couple | – | Diagnostic Test: Time Lapse (material to observe embryonic development)Couple with female aged under 37 years |
Who may qualify
- Ages
- 18 to 37 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Couple with female aged under 37 years
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- If ICSI performed with testicular, epididymal or frozen spermatozoa
- If one or both of the couple take antioxidant treatments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | Couple |
Primary outcome
embryonic development kinetics
Time frame: 6 days after ICSI
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
4 secondary outcomes
Spermatic DNA fragmentation
Time frame: at day 1
Spermatic DNA Compaction
Time frame: at day 1
Spermatic DNA Oxidation
Time frame: at day 1
Spermatic DNA methylation
Time frame: at day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Florence BRUGNON principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spermatic Parameters and Embryonic Kinetics, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick LACARIN (04 73 75 11 95, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
embryonic development kinetics (time frame: 6 days after ICSI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2017.