AneuploidyPolar BodyNCT01574404
Polar Body Biopsy for Preimplantation Genetic Screening
A study testing Polar body biopsy with PGS in people with Aneuploidy, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
People with infertility undergoing in vitro fertilization (IVF) can test the embryos using a method called preimplantation genetic screening (PGS) before they are implanted in the uterus to possibly increase their chances of having a successful pregnancy. One or more cells are removed from the embryo. Read more about this study
- Who is it for?
- Ages 18 to 42 yearsHealthy volunteers can take part
- Conditions the study is for
- Aneuploidy
- What is being tested?
- Polar body biopsy with PGS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Dec 2014
- 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 18 to 42 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Are undergoing IVF/Intracytoplasmic sperm injection(ICSI)
- Are considering preimplantation genetic screening for aneuploidy
- Are between ages 18 and 42 inclusive (female partner)
Who cannot join
- Using sperm from a testicular source
- Fewer than 10 oocytes retrieved
- Fewer than 6 oocytes fertilized normally
- Complete fertilization failure (no oocytes fertilize)
Trial locations and contacts
1 site in 1 country.
United States1 site
Ronald O. Perelmand and Claudia Cohen Center for Reproductive Medicine
New York, New York, 10021
About this study
Official title: Polar Body Biopsy (PB) for Preimplantation Genetic Screening
People with infertility undergoing in vitro fertilization (IVF) can test the embryos using a method called preimplantation genetic screening (PGS) before they are implanted in the uterus to possibly increase their chances of having a successful pregnancy. One or more cells are removed from the embryo. The chromosomes inside the cells are then tested to identify normal or aneuploid embryo(s).
The investigators propose to evaluate a test called micro array analysis on the chromosomes of the first polar body. This method tests part of the egg that would normally be lost and may help us choose the embryo most likely to become a healthy baby.
Read the detailed description
The polar body (PB) technique makes use of the 23 chromosomes contained in the first polar body, a part of the egg that is extruded at ovulation. Normally the first polar body disintegrates. However, it can be salvaged by polar body biopsy prior to this so that the chromosomes within can be analyzed. PB has three distinct advantages over conventional Fluorescent in-situ Hybridization (FISH) analysis. First, the polar body biopsy is performed on the day that the oocyte is retrieved (day 0) rather than day 3 so results are available earlier. Secondly, this methodology does not remove cells from the growing embryo. The polar body biopsy removes genetic material that would otherwise degrade. Finally, microarray analysis evaluates all 23 chromosomes while only 9-10 chromosomes can be studied with FISH analysis.
The investigators propose to perform microarray analysis in 50 IVF/ICSI (intracytoplasmic sperm injection) patients undergoing PGS.
Day 0 ICSI; PB* Day 1 Day 2 Day 3 Embryo biopsy with FISH or Microarray analysis Day 4 Day 5 Embryo transfer or embryo biopsy with Microarray analysis followed by Embryo Cryopreservation
Polar body biopsies will be frozen and later analyzed, The PB results will remain undisclosed until the end of the study period. PB results will not be used to guide treatment or clinical management. Embryos will be chosen or deselected for transfer solely based on the standard of care treatment aneuploidy screening analysis.
The three specific aims of the project are as follows:
- To determine the efficacy of PB biopsy and analysis by comparing the PB results to the Fluorescent in-situ Hybridization (FISH)/microarray results
- To evaluate the safety of PB by comparing the implantation , miscarriage, pregnancy, and delivery rates
- To determine the error rate of FISH analysis by analyzing the remaining cells in embryos determined to be abnormal by initial FISH/microarray analysis
- Conditions
- Aneuploidy
- Being tested
- Polar body biopsy with PGS
- Keywords
- PGS,PGD, IVF, Polar Body Biopsy, FISH, Microarray analysis
- Medical subject headings
- Aneuploidy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polar body biopsy with PGSProcedure or surgery
PB biopsy and analysis by comparing the PB results to the FISH/microarray results
| Study group | Role | What they receive |
|---|---|---|
| Polar Body Biopsy with PGS | Experimental | Polar Body Biopsy with Pre implantation genetic screening Receives: Procedure: Polar body biopsy with PGS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of polar biopsy and preimplantation genetic analysis
To determine the efficacy of PB biopsy and analysis by comparing the PB results to the FISH/microarray results
Measured: 1 year
Secondary outcomes (1)
Safety of polar biopsy
To evaluate the safety of polar biopsy by comparing the implantation, miscarriage, pregnancy, and delivery rates
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 Apr 2012 (estimated)
- Study startSep 2011
- Primary completionJul 2012
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AneuploidyStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Glenn Schattman, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01574404
- Sponsor's protocol ID
- 0911010734
- Acronym
- Polar Body
- Status last verified
- Jun 2015
- First submitted
- 16 Mar 2012
- Last updated
- 11 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polar Body Biopsy (PB) for Preimplantation Genetic Screening
- ClinicalTrials.gov ID
- NCT01574404
- Acronym / sponsor ID
- Polar Body / 0911010734
- Conditions
- Aneuploidy
- Keywords
- PGS,PGD, IVF, Polar Body Biopsy, FISH, Microarray analysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 10 Apr 2012 (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.
People with infertility undergoing in vitro fertilization (IVF) can test the embryos using a method called preimplantation genetic screening (PGS) before they are implanted in the uterus to possibly increase their chances of having a successful pregnancy. One or more cells are removed from the embryo. The chromosomes inside the cells are then tested to identify normal or aneuploid embryo(s).
The investigators propose to evaluate a test called micro array analysis on the chromosomes of the first polar body. This method tests part of the egg that would normally be lost and may help us choose the embryo most likely to become a healthy baby.
Detailed description
The polar body (PB) technique makes use of the 23 chromosomes contained in the first polar body, a part of the egg that is extruded at ovulation. Normally the first polar body disintegrates. However, it can be salvaged by polar body biopsy prior to this so that the chromosomes within can be analyzed. PB has three distinct advantages over conventional Fluorescent in-situ Hybridization (FISH) analysis. First, the polar body biopsy is performed on the day that the oocyte is retrieved (day 0) rather than day 3 so results are available earlier. Secondly, this methodology does not remove cells from the growing embryo. The polar body biopsy removes genetic material that would otherwise degrade. Finally, microarray analysis evaluates all 23 chromosomes while only 9-10 chromosomes can be studied with FISH analysis.
The investigators propose to perform microarray analysis in 50 IVF/ICSI (intracytoplasmic sperm injection) patients undergoing PGS.
Day 0 ICSI; PB* Day 1 Day 2 Day 3 Embryo biopsy with FISH or Microarray analysis Day 4 Day 5 Embryo transfer or embryo biopsy with Microarray analysis followed by Embryo Cryopreservation
Polar body biopsies will be frozen and later analyzed, The PB results will remain undisclosed until the end of the study period. PB results will not be used to guide treatment or clinical management. Embryos will be chosen or deselected for transfer solely based on the standard of care treatment aneuploidy screening analysis.
The three specific aims of the project are as follows:
- To determine the efficacy of PB biopsy and analysis by comparing the PB results to the Fluorescent in-situ Hybridization (FISH)/microarray results
- To evaluate the safety of PB by comparing the implantation , miscarriage, pregnancy, and delivery rates
- To determine the error rate of FISH analysis by analyzing the remaining cells in embryos determined to be abnormal by initial FISH/microarray analysis
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Polar Body Biopsy with PGS | Experimental | Procedure: Polar body biopsy with PGSPolar Body Biopsy with Pre implantation genetic screening |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Are undergoing IVF/Intracytoplasmic sperm injection(ICSI)
- Are considering preimplantation genetic screening for aneuploidy
- Are between ages 18 and 42 inclusive (female partner)
Key exclusion criteria (4 listed)
- Using sperm from a testicular source
- Fewer than 10 oocytes retrieved
- Fewer than 6 oocytes fertilized normally
- Complete fertilization failure (no oocytes fertilize)
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 |
|---|---|---|
| Polar body biopsy with PGSPB biopsy and analysis by comparing the PB results to the FISH/microarray results | Procedure or surgery | Polar Body Biopsy with PGS |
Primary outcome
Efficacy of polar biopsy and preimplantation genetic analysis
Time frame: 1 year
To determine the efficacy of PB biopsy and analysis by comparing the PB results to the FISH/microarray results
1 secondary outcome
Safety of polar biopsy
Time frame: 1 year
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 11 Jun 2015.
- Related InfoLink provided by the sponsor.
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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.
Glenn Schattman principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polar body biopsy with PGS in people with Aneuploidy, run by Weill Medical College of Cornell University 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 3 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: finished, as of the sponsor's last update on 11 Jun 2015. 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?
Efficacy of polar biopsy and preimplantation genetic analysis (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 11 Jun 2015.