InfertilityNCT02480491
Study of Free DNA Content of Embryo Culture Medium as a Non-Invasive Tool for Embryo Assessment
An observational study of Infertility, run by Sadat City University.
Trial summary
Study of Cell Free DNA Content of Human Embryo Culture Medium as a Non-Invasive Tool for Embryo Assessment in intra cytoplasmic sperm injection Treatment Cycles. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- measuring cell freeDNA
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to May 2015
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: ICSI Treatment Cycles females
Who may be able to join
- third day embryos
Who cannot join
- less than third day embryos
About this study
Official title: Study of Cell Free DNA Content of Human Embryo Culture Medium as a Non-Invasive Tool for Embryo Assessment in ICSI Treatment Cycles
Study of Cell Free DNA Content of Human Embryo Culture Medium as a Non-Invasive Tool for Embryo Assessment in intra cytoplasmic sperm injection Treatment Cycles.
Read the detailed description
The aim of the present study is to determine whether cell free DNA content of the culture medium of the human embryo correlates with the quality and reproductive potential of embryos in ICSI cycles and, thus, to look for a new non invasive tool of assessing embryo quality beside morphological assessment. Determining a rapid, noninvasive method for the assessment of the developmental potential of embryos may be a great achievement
- Conditions
- Infertility
- Being tested
- measuring cell freeDNA
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
measuring cell freeDNAOther
measuring cell free DNA using PCR
| Study group | Role | What they receive |
|---|---|---|
| Third day embryos | embryos culture media during third day after fertilization Receives: Other: measuring cell freeDNA | |
| Fifth day embryos | embryos culture media during fifth day after fertilization Receives: Other: measuring cell freeDNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
correlations between levels of measured cell free DNA and embryo quality.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2015 (estimated)
- Study startJan 2014
- Primary completionFeb 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies 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
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sadat City University
- Sponsor type
- University, hospital or other
- Collaborators
- Ain Shams University
- Responsible party
- Principal investigator, Azza Awad Abdel Razik Mohamed, Sadat City University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02480491
- Sponsor's protocol ID
- SCS-1
- Status last verified
- Jun 2015
- First submitted
- 20 Jun 2015
- Last updated
- 24 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Cell Free DNA Content of Human Embryo Culture Medium as a Non-Invasive Tool for Embryo Assessment in ICSI Treatment Cycles
- ClinicalTrials.gov ID
- NCT02480491
- Acronym / sponsor ID
- SCS-1
- Conditions
- Infertility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Sadat City UniversityUniversity, hospital or other
- Collaborators
- Ain Shams University
- Study start
- Jan 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 24 Jun 2015 (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.
Study of Cell Free DNA Content of Human Embryo Culture Medium as a Non-Invasive Tool for Embryo Assessment in intra cytoplasmic sperm injection Treatment Cycles.
Detailed description
The aim of the present study is to determine whether cell free DNA content of the culture medium of the human embryo correlates with the quality and reproductive potential of embryos in ICSI cycles and, thus, to look for a new non invasive tool of assessing embryo quality beside morphological assessment. Determining a rapid, noninvasive method for the assessment of the developmental potential of embryos may be a great achievement
Study design
- Observational model
- Cohort
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Third day embryos | – | Other: measuring cell freeDNAembryos culture media during third day after fertilization |
| Fifth day embryos | – | Other: measuring cell freeDNAembryos culture media during fifth day after fertilization |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- ICSI Treatment Cycles females
Key inclusion criteria (1 listed)
- third day embryos
Key exclusion criteria (1 listed)
- less than third day embryos
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 |
|---|---|---|
| measuring cell freeDNAmeasuring cell free DNA using PCR | Other | Fifth day embryos, Third day embryos |
Primary outcome
correlations between levels of measured cell free DNA and embryo quality.
Time frame: 12 months
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 24 Jun 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, run by Sadat City University.
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 1 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 24 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
correlations between levels of measured cell free DNA and embryo quality. (time frame: 12 months). 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 24 Jun 2015.