Prospective Randomized Trial of Preimplantation Genetic Testing for Aneuploidy (PGT-A) in Women Over 36 Years of Age
Preimplantation Genetic Testing for Aneuploidy (PGT-A) in Women Over 36 Years of Age
Sponsors
Lead Sponsor
Collaborators
Source
Stanford University
Oversight Info
Has Dmc
No
Is Fda Regulated Drug
No
Is Fda Regulated Device
No
Brief Summary
To compare pregnancy and live birth rates after untested blastocyst transfer compared to
transfer of a single euploid blastocyst after PGT-A among women over age 36 using an intent
to treat analysis.
Detailed Description
Pre-implantation genetic testing for aneuploidy (PGT-A) is routinely performed as part of in
vitro fertilization (IVF) with the goal of screening for large chromosomal deletions or
duplications and identifying chromosomally normal, or euploid, embryos for subsequent
transfer. PGT-A is currently offered to any infertile patient pursuing IVF treatment. By
screening a cohort of embryos created from IVF using PGT-A and selecting the chromosomally
normal embryos for transfer, PGT-A has been shown in several studies of infertile patients to
decrease time to pregnancy and decrease miscarriage rates. The likelihood of chromosomal
abnormalities in an embryo is strongly correlated with maternal age, with increasing maternal
age also associated with increased miscarriage rate. The benefit of PGT-A for improving live
birth rate and decreasing miscarriage rate has been shown among young patients (less than 35
years of age) who typically have several embryos from a single IVF cycle, thus can utilize
PGT-A as a selection tool to prioritize chromosomally normal embryos for transfer. Patients
undergoing PGT-A, regardless of age, are encouraged to obtain standard antenatal screening as
recommended by their obstetrician and PGT-A does not replace any non-invasive or invasive
antenatal screening test.
The benefit of PGT-A for improving clinical outcomes in poor prognosis, older patients,
however, is not well established. In this patient population the risks, benefits and costs of
PGT-A may vary. Older patients have a higher risk of having chromosomally abnormal embryos
from an IVF cycle, which are not recommended for subsequent embryo transfer. Older patients
also typically have lower ovarian reserve, and therefore a smaller number of embryos from a
single IVF cycle. Therefore, older patients who elect for PGT-A have a risk of having no
chromosomally normal embryos for transfer due to a small number of embryos in the cohort and
a high rate of chromosomal abnormalities (for example, 80% of embryos from a 40 year old
patient would be expected to be chromosomally abnormal). Risks of PGT-A include damage to the
embryo as part of the embryo biopsy and freeze/thaw cycle and cost. The risk/benefit ratio of
PGT-A among older patients has not been rigorously evaluated. As a tangible first step, our
current objective is to conduct a prospective randomized study evaluating the benefit of
PGT-A in poor prognosis patients. To achieve this objective, the investigators propose the
following specific aim: To compare pregnancy and live birth rates after untested blastocyst
transfer compared to transfer of a single euploid blastocyst after PGT-A among women over age
36 using an intent to treat analysis.
Funding for this study is provided by Genomic Prediction, LLC
Overall Status
Not yet recruiting
Start Date
2020-01-01
Completion Date
2024-01-01
Primary Completion Date
2023-01-01
Phase
N/A
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
Live birth rate |
Up to 18 months |
Secondary Outcome
Measure |
Time Frame |
|
Miscarriage rate |
Up to 18 months |
Enrollment
200
Condition
Intervention
Intervention Type
Procedure
Intervention Name
Description
24-chromosome screening for aneuploidy
Arm Group Label
PGT-A transfer
Other Name
Preimplantation genetic screening (PGS)
Eligibility
Criteria
Inclusion Criteria:
- Women with an indication for IVF between ages 36 0/12-42 11/12 at IVF cycle start
planning to perform PGT-A
- Utilization of ICSI or conventional insemination
- Utilization of ejaculated or testicular sperm
- Utilization of autologous or donor sperm
- All COH stimulation protocols
Exclusion criteria:
- Patients desiring PGT-A for sex selection
- Utilization of donor oocytes
- Utilization of gestational carrier
- PGD/single gene disorders
- Translocation carriers
Gender
Female
Minimum Age
36 Years
Maximum Age
42 Years
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
Ruth B Lathi, MD |
Principal Investigator |
Stanford Hospital and Clinics |
Overall Contact
Verification Date
2019-12-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Principal Investigator
Investigator Affiliation
Stanford University
Investigator Full Name
Ruth Bunker Lathi
Investigator Title
Principal Investigator
Has Expanded Access
No
Condition Browse
Number Of Arms
2
Arm Group
Arm Group Label
PGT-A transfer
Arm Group Type
Experimental
Description
Transfer of single chromosomally normal (euploid) blastocyst after PGT-A
Arm Group Label
Untested blastocyst transfer
Arm Group Type
No Intervention
Description
Transfer up to 2 untested blastocysts
Firstreceived Results Date
N/A
Overall Contact Backup
Reference
Citation
Practice Committees of the American Society for Reproductive Medicine and the Society for Assisted Reproductive Technology. Electronic address: [email protected]; Practice Committees of the American Society for Reproductive Medicine and the Society for Assisted Reproductive Technology. The use of preimplantation genetic testing for aneuploidy (PGT-A): a committee opinion. Fertil Steril. 2018 Mar;109(3):429-436. doi: 10.1016/j.fertnstert.2018.01.002. Review.
PMID
29566854
Citation
Yang Z, Liu J, Collins GS, Salem SA, Liu X, Lyle SS, Peck AC, Sills ES, Salem RD. Selection of single blastocysts for fresh transfer via standard morphology assessment alone and with array CGH for good prognosis IVF patients: results from a randomized pilot study. Mol Cytogenet. 2012 May 2;5(1):24. doi: 10.1186/1755-8166-5-24.
PMID
22551456
Citation
Forman EJ, Hong KH, Ferry KM, Tao X, Taylor D, Levy B, Treff NR, Scott RT Jr. In vitro fertilization with single euploid blastocyst transfer: a randomized controlled trial. Fertil Steril. 2013 Jul;100(1):100-7.e1. doi: 10.1016/j.fertnstert.2013.02.056. Epub 2013 Mar 30.
PMID
23548942
Citation
Scott RT Jr, Upham KM, Forman EJ, Hong KH, Scott KL, Taylor D, Tao X, Treff NR. Blastocyst biopsy with comprehensive chromosome screening and fresh embryo transfer significantly increases in vitro fertilization implantation and delivery rates: a randomized controlled trial. Fertil Steril. 2013 Sep;100(3):697-703. doi: 10.1016/j.fertnstert.2013.04.035. Epub 2013 Jun 1.
PMID
23731996
Acronym
GETSET
Patient Data
Sharing Ipd
No
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Single Group Assignment
Intervention Model Description
Prospective randomized open label clinical trial
Primary Purpose
Treatment
Masking
None (Open Label)
Study First Submitted
November 15, 2019
Study First Submitted Qc
November 15, 2019
Study First Posted
November 19, 2019
Last Update Submitted
December 13, 2019
Last Update Submitted Qc
December 13, 2019
Last Update Posted
December 17, 2019
ClinicalTrials.gov processed this data on January 15, 2020
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.