Single-Gene DiseaseNCT02359747
Analysis of Human Genomic DNA in Embryo's Culture Media
An observational study of Single-Gene Disease, run by Cervesi Hospital, Cattolica, Italy at 2 sites in Italy.
Trial summary
try to find genomic DNA in culture medium after the embryos develop on Day 3 and Day 5 also in single step culture media. using direct PCR Polymerase Chain Reaction and also WGA Whole Genome Amplification before PCR and sequencing of the samples to find the point mutation Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Single-Gene Disease
- What is being tested?
- Polymerase Chain Reaction and Whole Genome Amplification
- How many people
- 100 participants
- Where
- 2 sitesItaly
- Study dates
- 12 Jan 2020to Dec 2022
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Study population: all the mediun descarted after embryos culture in vitro
Who may be able to join
- all the patients undergoing IVF treatment at Cervesi Hospital
Who cannot join
- patients with embryos that can't be cultured from day 0 (insemination day) to day 5/6 (blastocyst stage)
Trial locations and contacts
2 sites in 1 country.
Italy2 sites, 2 recruiting
- Recruiting
Cervesi Hospital
Cattolica, 47841
Luca Galluzzi, silviadestefani@ymail.com
- Recruiting
cervesi Hospital
Cattolica, 47841
silvia de stefani, silviadestefani@ymail.com
About this study
Official title: Analysis of Human Genomic DNA in Embryo's Culture Media Targeting on a Single Gene Disease and Point Mutations
try to find genomic DNA in culture medium after the embryos develop on Day 3 and Day 5 also in single step culture media. using direct PCR Polymerase Chain Reaction and also WGA Whole Genome Amplification before PCR and sequencing of the samples to find the point mutation
Read the detailed description
Human fertilized oocytes were individually cultured from Day 1 to Day 3, and from day 3 to days 5/6, in 10 ul medium. A total of 100 samples (50 spent media from Day 3 and 50 from Day 5/6) will be use in the study.
Double-stranded DNA (dsDNA) amplifiability will be evaluated in embryos culture media by quantitative PCR on a multicopy gene target (TBC1D3). Quantification will be made with a standard curve constructed with genomic DNA (with culture media -day 3 and day5-, to take into account media inhibitory effects) TSPY1 amplification will be use to assess the presence of Y chromosome WGA followed by PCR on a single copy gene (MTHFR gene) will be performed on a subset of some samples to monitor the C677T polymorphism (genotyping by sequencing) WGA followed by PCR on a single copy gene (MTHFR) will be also performed on blastocoele fluids
- Conditions
- Single-Gene Disease
- Being tested
- Polymerase Chain Reaction and Whole Genome Amplification
- Keywords
- free gDNA, culture media
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polymerase Chain Reaction and Whole Genome AmplificationGenetic
Polymerase Chain Reaction and Whole Genome Amplification
| Study group | Role | What they receive |
|---|---|---|
| In Vitro Fertilization treatment | culture medium discarded after IVF treatment Receives: Genetic: Polymerase Chain Reaction and Whole Genome Amplification |
What is being measured
The primary outcome is the main question the study is designed to answer.
genomic DNA in culture medium (pg)
Measured: 1 year
Secondary outcomes (1)
amplification of point mutation
amplification of point mutation with PCR (polymerase chain reaction)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2015 (estimated)
- Study start12 Jan 2020
- Primary completionNov 2021 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Single-Gene DiseaseStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cervesi Hospital, Cattolica, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Palini Simone, Cervesi Hospital, Cattolica, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02359747
- Sponsor's protocol ID
- PGD on culture media is easy
- Status last verified
- Feb 2021
- First submitted
- 3 Feb 2015
- Last updated
- 10 Feb 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Human Genomic DNA in Embryo's Culture Media Targeting on a Single Gene Disease and Point Mutations
- ClinicalTrials.gov ID
- NCT02359747
- Acronym / sponsor ID
- PGD on culture media is easy
- Conditions
- Single-Gene Disease
- Keywords
- free gDNA, culture media
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cervesi Hospital, Cattolica, ItalyUniversity, hospital or other
- Study start
- 12 Jan 2020 (actual)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 10 Feb 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.
try to find genomic DNA in culture medium after the embryos develop on Day 3 and Day 5 also in single step culture media. using direct PCR Polymerase Chain Reaction and also WGA Whole Genome Amplification before PCR and sequencing of the samples to find the point mutation
Detailed description
Human fertilized oocytes were individually cultured from Day 1 to Day 3, and from day 3 to days 5/6, in 10 ul medium. A total of 100 samples (50 spent media from Day 3 and 50 from Day 5/6) will be use in the study.
Double-stranded DNA (dsDNA) amplifiability will be evaluated in embryos culture media by quantitative PCR on a multicopy gene target (TBC1D3). Quantification will be made with a standard curve constructed with genomic DNA (with culture media -day 3 and day5-, to take into account media inhibitory effects) TSPY1 amplification will be use to assess the presence of Y chromosome WGA followed by PCR on a single copy gene (MTHFR gene) will be performed on a subset of some samples to monitor the C677T polymorphism (genotyping by sequencing) WGA followed by PCR on a single copy gene (MTHFR) will be also performed on blastocoele fluids
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| In Vitro Fertilization treatment | – | Genetic: Polymerase Chain Reaction and Whole Genome Amplificationculture medium discarded after IVF treatment |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- all the mediun descarted after embryos culture in vitro
Key inclusion criteria (1 listed)
- all the patients undergoing IVF treatment at Cervesi Hospital
Key exclusion criteria (1 listed)
- patients with embryos that can't be cultured from day 0 (insemination day) to day 5/6 (blastocyst stage)
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 |
|---|---|---|
| Polymerase Chain Reaction and Whole Genome AmplificationPolymerase Chain Reaction and Whole Genome Amplification | Genetic | In Vitro Fertilization treatment |
Primary outcome
genomic DNA in culture medium (pg)
Time frame: 1 year
1 secondary outcome
amplification of point mutation
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
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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.
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 Single-Gene Disease, run by Cervesi Hospital, Cattolica, Italy at 2 sites in Italy.
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: status not confirmed, as of the sponsor's last update on 10 Feb 2021. 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 Italy. 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 Simone Palini (+393394572101, simonepalini@yahoo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
genomic DNA in culture medium (pg) (time frame: 1 year). 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 10 Feb 2021.