NCT03604107

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
237

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2018

Typical duration for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 14, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 27, 2018

Completed
3 days until next milestone

Study Start

First participant enrolled

July 30, 2018

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

January 14, 2022

Status Verified

January 1, 2022

Enrollment Period

2.2 years

First QC Date

June 14, 2018

Last Update Submit

January 13, 2022

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

Preimplantation Genetic Testing-AneuploidyGENETIC

trophectoderm biopsy samples will be analyzed for karyotype after clinical outcome is determined

Eligibility Criteria

Age18 Years - 42 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Infertile couples attempting conception through in vitro fertilization

You may qualify if:

  • Couples electing embryonic aneuploidy screening (PGS)
  • Couples electing single embryo transfer

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Reproductive Medicine Associates of Florida

Lake Mary, Florida, 32746, United States

Location

Reproductive Medicine Associates of New Jersey

Basking Ridge, New Jersey, 07960, United States

Location

Reproductive Medicine Associates of Pennsylvania

Allentown, Pennsylvania, 18104, United States

Location

Reproductive Medicine Associates of Philadelphia

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (1)

  • 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.

    PMID: 32863013DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

serum, buccal swab, rectal/vaginal swab, endometrial biopsy and aspirate, discarded specimens leftover after an IVF procedure

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Richard T Scott Jr., MD, HCLD

    IVI RMA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2018

First Posted

July 27, 2018

Study Start

July 30, 2018

Primary Completion

September 30, 2020

Study Completion

December 1, 2020

Last Updated

January 14, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

US(4)