Predictive Value of Embryonic Testing | NCT03604107

Studies
Predictive Value of Embryonic Testing

NCT03604107

Sponsor

Reproductive Medicine Associates of New Jersey

Status

Completed

Last Update Posted

Jan 14, 2022Actual

Enrollment

237Actual

Phase

Not provided

Conditions

Infertility

Interventions

Preimplantation Genetic Testing-Aneuploidy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 30, 2018Actual

Primary Completion Date

Sep 30, 2020Actual

Completion Date

Dec 1, 2020Actual

First Submitted Date

Jun 14, 2018

First Submission Date that Met QC Criteria

Jul 19, 2018

First Posted Date

Jul 27, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 13, 2022

Last Update Posted Date

Jan 14, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

237Actual

Name	Type	Description	Arm Group Labels	Other Names
Preimplantation Genetic Testing-Aneuploidy	Genetic	trophectoderm biopsy samples will be analyzed for karyotype after clinical outcome is determined

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Predictive Value of Aneuploidy Screening	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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

42 Years

Standard Ages

Adult

Study Population

Infertile couples attempting conception through in vitro fertilization

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Richard T Scott Jr., MD, HCLD	IVI RMA	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Reproductive Medicine Associates of Florida		Lake Mary	Florida	32746	United States
Reproductive Medicine Associates of New Jersey

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32863013	Derived	Tiegs AW, Tao X, Zhan Y, Whitehead C, Kim J, Hanson B, Osman E, Kim TJ, Patounakis G, Gutmann J, Castelbaum A, Seli E, Jalas C, Scott RT Jr. A multicenter, prospective, blinded, nonselection study evaluating the predictive value of an aneuploid diagnosis using a targeted next-generation sequencing-based preimplantation genetic testing for aneuploidy assay and impact of biopsy. Fertil Steril. 2021 Mar;115(3):627-637. doi: 10.1016/j.fertnstert.2020.07.052. Epub 2020 Aug 28.

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases