- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03604107
Predictive Value of Embryonic Testing (PROV-ET)
January 13, 2022 updated by: Reproductive Medicine Associates of New Jersey
Evaluation of the Efficacy of Preimplantation Genetic Screening (PGS) in Predicting Embryonic Ploidy and Subsequent Pregnancy Outcomes in in Vitro Fertilization (IVF) Cycles
The primary objective of this study is to determine the predictive value of preimplantation genetic screening (PGS) as a marker of embryonic competence.
Secondary objectives are to define the related or independent predictive values of other proposed markers of embryonic and maternal reproductive competence in assisted reproductive technology (ART) cycles.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Patients participating in the study will undergo a routine in vitro fertilization cycle.
Trophectoderm biopsy will be performed on all blastocysts however biopsy samples will not be analyzed till the clinical outcome has been determined.
The single, morphologically best embryo available will be selected for transfer.
All clinical and laboratory care is identical to that of which subjects would receive if they were not participating in the study.
This includes all pretreatment screening, in-cycle treatment, embryology procedures, single embryo transfer, pregnancy testing, and pregnancy follow-up (if pregnancy occurs).
Study Type
Observational
Enrollment (Actual)
237
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Florida
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Lake Mary, Florida, United States, 32746
- Reproductive Medicine Associates of Florida
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New Jersey
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Basking Ridge, New Jersey, United States, 07960
- Reproductive Medicine Associates of New Jersey
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Pennsylvania
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Allentown, Pennsylvania, United States, 18104
- Reproductive Medicine Associates of Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
- Reproductive Medicine Associates of Philadelphia
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 42 years (Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Infertile couples attempting conception through in vitro fertilization
Description
Inclusion Criteria:
- Couples electing embryonic aneuploidy screening (PGS)
- Couples electing single embryo transfer
Exclusion Criteria:
- Any prior failed IVF cycle
- Diagnosis of endometrial insufficiency: prior cycle with maximal endometrial thickness ≤ 6mm, abnormal endometrial pattern (failure to attain a trilaminar appearance), persistent endometrial fluid
- Diagnosis of chronic endometritis
- Maximum day 3 FSH level of 12 or higher
- Anti-mullerian hormone level less than 0.5 g/mL, tested within previous year
- Total basal antral follicle count less than 8 follicles
- Male partner with <100,000 total motile spermatozoa per ejaculate (donor sperm is acceptable)
- BMI <18.5 or > 35
- Personal history of recurrent pregnancy loss (two or more pregnancy losses)
- Use of oocyte donation
- Use of gestational carrier
- Medical condition predisposing patient to high risk pregnancy
- Use of surgical procedures to obtain sperm
- Presence of hydrosalpinges that communicate with endometrial cavity
- Any contraindications to undergoing in vitro fertilization or gonadotropin stimulation
- Single gene disorder or chromosomal rearrangement requiring a more detailed embryonic genetic analysis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Predictive Value of Aneuploidy Screening
Time Frame: approximately 1 month post clinical outcome
|
Determine confidence intervals that a euploid embryo will implant, an aneuploid embryo will not implant, and the likelihood of mosaic and segmental aneuploid embryos implanting and describe their outcomes.
|
approximately 1 month post clinical outcome
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Richard T Scott Jr., MD, HCLD, IVI RMA
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 30, 2018
Primary Completion (Actual)
September 30, 2020
Study Completion (Actual)
December 1, 2020
Study Registration Dates
First Submitted
June 14, 2018
First Submitted That Met QC Criteria
July 19, 2018
First Posted (Actual)
July 27, 2018
Study Record Updates
Last Update Posted (Actual)
January 14, 2022
Last Update Submitted That Met QC Criteria
January 13, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RMA-2018-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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