Cylinical EmbryoNCT02155179
Sperm Pathology Samples and Morphokinetics
An observational study of Cylinical Embryo and Oligospermia, run by IVI Madrid at 2 sites in Spain.
Trial summary
The embryo kinetics may be a new prognostic factor for choosing the 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cylinical Embryo, Oligospermia
- How many people
- 112 participants
- Where
- 2 sitesSpain
- Study dates
- Aug 2014to Dec 2018
- 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 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Sperms samples of assisted reproduction treatments
Who may be able to join
- Sperm samples with more than 15 mill/ml of sperms, more than 40% of mobile sperms
- Sperm samples with less than 5 mill/ml of sperms, less than 10% of mobile sperms
Who cannot join
- sperm samples between 5 to 15 mil/ml of sperms and between 10% to 40% of mobile sperms
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Embryo Kinetics and Sperm Quality. Depends on the Sperm Quality the Embryo Cleavage Rate?
The embryo kinetics may be a new prognostic factor for choosing the 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 semen quality in the embryo kinetic.
In this study The investigators propose that the sperm quality may has influence in the embryo division.
- Conditions
- Cylinical Embryo, Oligospermia
- Medical subject headings
- Oligospermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Good prognosis | Sperm samples >15mill/ml >30% progresive sperms | |
| bad prognosis | Sperm samples <5mill/ml <5% progresive sperms |
What is being measured
The primary outcome is the main question the study is designed to answer.
embryo division in 2, 3, 4, 5, 6, 7, 8, cells and blastocyst formation
Exact time of cell cleavages
Measured: between day 0 and day 5 of development
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2014 (estimated)
- Study startAug 2014
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cylinical EmbryoStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- IVI Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- david agudo, PhD, Principal investigator, lab coordinator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02155179
- Sponsor's protocol ID
- semen-esd
- Status last verified
- Aug 2019
- First submitted
- 2 Jun 2014
- Last updated
- 13 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Embryo Kinetics and Sperm Quality. Depends on the Sperm Quality the Embryo Cleavage Rate?
- ClinicalTrials.gov ID
- NCT02155179
- Acronym / sponsor ID
- semen-esd
- Conditions
- Cylinical Embryo, Oligospermia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- IVI MadridUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 4 Jun 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 embryo kinetics may be a new prognostic factor for choosing the 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 semen quality in the embryo kinetic.
In this study The investigators propose that the sperm quality may has influence in the embryo division.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Good prognosis | – | –Sperm samples >15mill/ml >30% progresive sperms |
| bad prognosis | – | –Sperm samples <5mill/ml <5% progresive sperms |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Sperms samples of assisted reproduction treatments
Key inclusion criteria (2 listed)
- Sperm samples with more than 15 mill/ml of sperms, more than 40% of mobile sperms
- Sperm samples with less than 5 mill/ml of sperms, less than 10% of mobile sperms
Key exclusion criteria (1 listed)
- sperm samples between 5 to 15 mil/ml of sperms and between 10% to 40% of mobile sperms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
embryo division in 2, 3, 4, 5, 6, 7, 8, cells and blastocyst formation
Time frame: between day 0 and day 5 of development
Exact time of cell cleavages
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2019.
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.
david agudo, PhD principal investigator
lab coordinator
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cylinical Embryo and Oligospermia, run by IVI Madrid at 2 sites 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 13 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
embryo division in 2, 3, 4, 5, 6, 7, 8, cells and blastocyst formation (time frame: between day 0 and day 5 of development). 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 Aug 2019.