Blastocyst TimeMACs-ESDNCT02214537
Does DNA Sperm Fragmentation Affects Embryo Morphokinetic?
A study testing MACS in people with Blastocyst Time and Pronuclear Appearance, run by IVI Madrid at 1 site in Spain.
Trial summary
The embryokinetics may be a new prognostic factor for choosing the human embryos with the highest implantation potential. In order to identify the factors that may affect the rate of embryo cleavage, there are many studies about morphokinetics and culture medium, oxygen tension, oocyte quality or type of medication… Read more about this study
- Who is it for?
- Ages 36 to 38 years
- Conditions the study is for
- Blastocyst Time, Pronuclear Appearance, Pronuclear Fading
- What is being tested?
- MACS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2016to Feb 2018
- Phase
- Interventional
- 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 36 to 38 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients 36 to 38 years
- Fresh sample semen
- Minimum 6 oocytes
- Semen sample with at least 5 million/ml and at least 30% of progressive motile sperm.
Who cannot join
- Patients younger than 36 or older than 38 years old
- Frozen semen sample
- Less tan 6 oocytes.
- Semen samples with less than 5 million / ml or less than 30% of motile sperm.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Embryo Development Measure Depending on the DNA Sperm Fragmentation
The embryokinetics may be a new prognostic factor for choosing the human embryos with the highest implantation potential. In order to identify the factors that may affect the rate of embryo cleavage, there are many studies about morphokinetics and culture medium, oxygen tension, oocyte quality or type of medication used for ovarian stimulation. However there are no published data with respect to the influence of sperm DNA fragmentation in the embryo kinetic.
- Conditions
- Blastocyst Time, Pronuclear Appearance, Pronuclear Fading, Embryo Compaction, Cleavage Times
- Being tested
- MACS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MACSOther
| Study group | Role | What they receive |
|---|---|---|
| MACS | Experimental | Patients with MACS Selection Receives: Other: MACS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of pronuclear appearance in hours.
We want to study whether differences exist in the time of appearance of pronuclei in those embryos that derived from semen samples from the two study groups
the minimum value of the difference to be detected; we said that about 3 hours apart.
Measured: The mean time of appearance of pronuclei is 3.3951 hours in our patients. We are going to evaluate pronuclear appearence time in hours in our study groups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2014 (estimated)
- Study startFeb 2016
- Primary completionFeb 2018
- Study completionFeb 2018
Why it stopped: Because we don´t have the necessary technology anymore
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blastocyst TimeStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- IVI Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Agudo Garcillan, IVI Madrid
- Investigators
- Manuela Alonso, Study director, IVI MadridDavid Agudo, PhD, Study director, IVI MadridMaria Testillano, Study chair, IVI MadridAlberto Pacheco, PhD, Study director, IVI Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02214537
- Sponsor's protocol ID
- MADDA12201301
- Acronym
- MACs-ESD
- Status last verified
- Apr 2018
- First submitted
- 25 Jul 2014
- Last updated
- 4 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Embryo Development Measure Depending on the DNA Sperm Fragmentation
- ClinicalTrials.gov ID
- NCT02214537
- Acronym / sponsor ID
- MACs-ESD / MADDA12201301
- Conditions
- Blastocyst Time, Pronuclear Appearance, Pronuclear Fading, Embryo Compaction, Cleavage Times
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Because we don´t have the necessary technology anymore
- Enrolment
- 60 participants (actual)
- Lead sponsor
- IVI MadridUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 12 Aug 2014 (estimated)
- 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.
The embryokinetics may be a new prognostic factor for choosing the human embryos with the highest implantation potential. In order to identify the factors that may affect the rate of embryo cleavage, there are many studies about morphokinetics and culture medium, oxygen tension, oocyte quality or type of medication used for ovarian stimulation. However there are no published data with respect to the influence of sperm DNA fragmentation in the embryo kinetic.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MACS | Experimental | Other: MACSPatients with MACS Selection |
Who may qualify
- Ages
- 36 to 38 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients 36 to 38 years
- Fresh sample semen
- Minimum 6 oocytes
- Semen sample with at least 5 million/ml and at least 30% of progressive motile sperm.
Key exclusion criteria (4 listed)
- Patients younger than 36 or older than 38 years old
- Frozen semen sample
- Less tan 6 oocytes.
- Semen samples with less than 5 million / ml or less than 30% of motile sperm.
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 |
|---|---|---|
| MACS | Other | MACS |
Primary outcome
Time of pronuclear appearance in hours.
Time frame: The mean time of appearance of pronuclei is 3.3951 hours in our patients. We are going to evaluate pronuclear appearence time in hours in our study groups
We want to study whether differences exist in the time of appearance of pronuclei in those embryos that derived from semen samples from the two study groups the minimum value of the difference to be detected; we said that about 3 hours apart.
Results and safety
The study was stopped early (reason given: Because we don´t have the necessary technology anymore). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2018.
Related trials for Blastocyst Time
RecruitingObservational study
Study of Abnormally Fertilized Embryos
Infertility (IVF Patients)
Enrolling by invitationObservational study
Blastocyst AI Assisted Morphokinetics in ART
Infertility Assisted Reproductive Technology, Infertility (IVF Patients)
Recruiting
Impact of Dry vs Humidified Culture Conditions on Blastocyst Development and Aneuploidy: A Time-lapse Sibling Oocyte Study
Incubator Stay, Total Blastulation
RecruitingObservational study
International Pilot Study for Dual Non-invasive Assesment of Embryo Development
Infertility
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.
Manuela Alonso study director
IVI Madrid
David Agudo, PhD study director
IVI Madrid
Maria Testillano study chair
IVI Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MACS in people with Blastocyst Time and Pronuclear Appearance, run by IVI Madrid at 1 site in Spain.
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 4 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: stopped early, as of the sponsor's last update on 4 Apr 2018. 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 Spain. 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?
The study was stopped early (reason given: Because we don´t have the necessary technology anymore). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time of pronuclear appearance in hours. (time frame: The mean time of appearance of pronuclei is 3.3951 hours in our patients. We are going to evaluate pronuclear appearence time in hours in our study groups). 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 4 Apr 2018.