Embryos With Preimplantation Genetic Testing for Aneuploidies (PGT-A) Inconclusive Result: Clinical Implications

NCT04734769 | Unknown

• 1 other identifier: 2011-VGO-095-EM
• Study Type: observational
• Target: 600
• Locations: 0 countries
• Sites: N/A

Brief Summary

One of the most remarkable improvements in trophoectoderm cells biopsy is the robustness of diagnosis as result of analyzing multiple cells. However, there is a proportion of embryos that lack of diagnosis due to amplification failure or inconclusive results ranging between 0,4% and 6%. Information about embryo repeated biopsy after an inconclusive result in a first biopsy is very scarce. No specific conclusions can be drawn, due to the limited information currently available concerning reproductive outcomes for patients who had embryo transfer after a second biopsy, due to a first one having an inconclusive result. Investigators purpose a multicenter retrospective observational study with the aim to evaluate the reproductive potential of re-biopsied blastocyst with inconclusive results on preimplantation genetic screening for aneuploidy (PGT-A) using the implantation rate (IR) and ongoing pregnancy rate (OPR) as principal variables.

Conditions

Embryo Disorder

Outcome Measures

Primary Outcomes (1)

• Implantation rate

  Analyze implantation rate in the groups

  Since July 2019 to December 2020

Study Arms (2)

Cycles of embryo transfer from patients with at least one euploid embryo (no rebiopsy group)

Collect retrospectively clinical data on reproductive outcomes

Other: Collect retrospectively clinical data on reproductive outcomes

Rebiopsy group:

Collect retrospectively clinical data on reproductive outcomes

Other: Collect retrospectively clinical data on reproductive outcomes

Interventions

Collect retrospectively clinical data on reproductive outcomes OTHER

Collect retrospectively clinical data on reproductive outcomes

Cycles of embryo transfer from patients with at least one euploid embryo (no rebiopsy group); Rebiopsy group:

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

All patients with indication of PGT-A (advanced maternal age, male factor, recurrent pregnancy loss, recurrent implantation failure, previous aneuploidy pregnancy) with differed single embryo transfer.

You may qualify if:

• Cycles of embryo transfer from patients with at least one euploid embryo (no rebiopsy group):
• Women age 18-45 years.
• PGT-A Indication.
• All embryos with informative results.
• Women age 18-45 years.
• PGT-A Indication.
• At least one embryo result with lack of diagnosis.
• At least one rebiopsied embryo.
• At least one euploid result from rebiopsied embryo.
• Single embryo transfer.

You may not qualify if:

• Double embryo transfer

Sponsors & Collaborators

• IVI Vigo: lead
• Instituto Valenciano de Infertilidad, IVI VALENCIA: collaborator
• Juno Therapeutics, Inc., a Bristol-Myers Squibb Company: collaborator

Related Publications (2)

• Cobo A, Castello D, Vallejo B, Albert C, de los Santos JM, Remohi J. Outcome of cryotransfer of embryos developed from vitrified oocytes: double vitrification has no impact on delivery rates. Fertil Steril. 2013 May;99(6):1623-30. doi: 10.1016/j.fertnstert.2013.01.106. Epub 2013 Feb 14.

  PMID: 23415972 BACKGROUND

• Chen HH, Huang CC, Cheng EH, Lee TH, Chien LF, Lee MS. Optimal timing of blastocyst vitrification after trophectoderm biopsy for preimplantation genetic screening. PLoS One. 2017 Oct 5;12(10):e0185747. doi: 10.1371/journal.pone.0185747. eCollection 2017.

  PMID: 28982142 BACKGROUND

Study Officials

• Elkin Muñoz

  IVI Vigo

  STUDY DIRECTOR

Central Study Contacts

Elkin Muñoz

CONTACT

986021860; elkin.munoz@ivirma.com

Agustina Ramos Gutierrez

CONTACT

986021860; agustina.ramos@ivirma.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2021
• First Posted: February 2, 2021
• Study Start: February 20, 2021
• Primary Completion: February 21, 2021
• Study Completion: November 25, 2022
• Last Updated: February 2, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share