Balanced Chromosomal TranslocationNCT02178865
Predicting Normal vs. Carrier Status in Euploid Embryos of Translocation Carriers
An observational study of Balanced Chromosomal Translocation, run by Reproductive Medicine Associates of New Jersey at 1 site in United States.
Trial summary
The purpose of this study is to assess the accuracy of predicting the normal or carrier status of human embryos resulting from in vitro-fertilization (IVF) from patients carrying a balanced translocation. Read more about this study
- Who is it for?
- Ages 7 years and olderHealthy volunteers can take part
- Conditions the study is for
- Balanced Chromosomal Translocation
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Feb 2017
- 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 7 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: patients with balanced translocations
Who may be able to join
- patients with balanced translocations who have undergone IVF
Who cannot join
- those who do not wish to know their child(s) karyotype
Trial locations and contacts
1 site in 1 country.
United States1 site
Reproductive Medicine Associates of New Jersey
Basking Ridge, New Jersey, 07920
About this study
Official title: Evaluation of the Accuracy of Predicting Normal or Carrier Status in Euploid Embryos Produced by Patients With Balanced Translocations
The purpose of this study is to assess the accuracy of predicting the normal or carrier status of human embryos resulting from in vitro-fertilization (IVF) from patients carrying a balanced translocation.
Read the detailed description
This study aims to evaluate the validity of using informative SNPs to distinguish balanced from normal embryos. This will involve acquiring material from families to set phase for informative SNPs, evaluation of existing and new embryo SNP array data, and follow up analysis of children born after applying the procedure.
- Conditions
- Balanced Chromosomal Translocation
- Keywords
- translocation
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 |
|---|---|---|
| translocation carrier | balanced translocation carriers who have undergone IVF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of correct predictions of normal vs. balanced ploidy status as compared to conventional karyotype
Measured: up to 12 months once pregnant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2015
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Balanced Chromosomal TranslocationStudies 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
- Case only
- Time perspective
- Other
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reproductive Medicine Associates of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard T Scott, MD, HCLD, Principal investigator, Reproductive Medicine Associates of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02178865
- Sponsor's protocol ID
- RMA-2014-01
- Status last verified
- Mar 2017
- First submitted
- 26 Jun 2014
- Last updated
- 17 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Accuracy of Predicting Normal or Carrier Status in Euploid Embryos Produced by Patients With Balanced Translocations
- ClinicalTrials.gov ID
- NCT02178865
- Acronym / sponsor ID
- RMA-2014-01
- Conditions
- Balanced Chromosomal Translocation
- Keywords
- translocation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Reproductive Medicine Associates of New JerseyUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 1 Jul 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 purpose of this study is to assess the accuracy of predicting the normal or carrier status of human embryos resulting from in vitro-fertilization (IVF) from patients carrying a balanced translocation.
Detailed description
This study aims to evaluate the validity of using informative SNPs to distinguish balanced from normal embryos. This will involve acquiring material from families to set phase for informative SNPs, evaluation of existing and new embryo SNP array data, and follow up analysis of children born after applying the procedure.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| translocation carrier | – | –balanced translocation carriers who have undergone IVF |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with balanced translocations
Key inclusion criteria (1 listed)
- patients with balanced translocations who have undergone IVF
Key exclusion criteria (1 listed)
- those who do not wish to know their child(s) karyotype
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
Proportion of correct predictions of normal vs. balanced ploidy status as compared to conventional karyotype
Time frame: up to 12 months once pregnant
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 17 Mar 2017.
- Individual participant dataSharing planned: No
Related trials for Balanced Chromosomal Translocation
Active, not recruiting
Insulin Balanced Infusion System
Hyperglycemia, Diabetes
Not yet recruiting
NutrImmune: Precision Nutrition to Improve Immunity in Individuals With Obesity
Obesity (BMI>30), Immune Abnormalities
RecruitingPhase 3
A Phase III Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With CKD Stage 3b and 4 (BalanceD-CKD)
Renal Insufficiency, Chronic
Not yet recruiting
Bioelectrical Response to Preoperative Hydration in Colorectal Surgery
Postoperative Complications
Not yet recruitingPhase 1/2
Propofol-Dexmedetomine Adjunction in Balanced Anesthesia for Minimally Invasive Cardiac Valve Surgery :Effect on Anesthetic Consumption ,Perioperative Outcomes,and Early Recovery
Balanced Anesthesia for Minimally Invasive Cardiac Valve Surgery
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.
Richard T Scott, MD, HCLD principal investigator
Reproductive Medicine Associates of New Jersey
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 Balanced Chromosomal Translocation, run by Reproductive Medicine Associates of New Jersey at 1 site in United States.
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 17 Mar 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 United States. 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?
Proportion of correct predictions of normal vs. balanced ploidy status as compared to conventional karyotype (time frame: up to 12 months once pregnant). 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 17 Mar 2017.