Correlation of the Genetic Constitution of the Spent Blastocyst Media

NCT06780605 | Completed

• 1 other identifier: IGX1-GCO-CR-23-04
• Study Type: observational
• Target: 230
• Locations: 1 country
• Sites: 2

Brief Summary

The main objective of this study is to improve niPGT-A (non-invasive Preimplantation Genetic Testing for Aneuploidies) to avoid the need of a biopsy to perform the genetic analysis of the embryo and to help in understanding the genetic constitution of different parts of the blastocyst (early stage of an embryo development). For this purpose, we aim to analyses the genetic material released by the embryo to the culture medium (also called Spent Blastocyst Media, SBM) from about 200 blastocysts donated to research by participants of assisted reproduction treatments. The results will be correlated with the ones obtained from performing the same analysis on biopsies taken from the outer (trophectoderm, TE) and the inner (inner cell mass, ICM) layer of cells in different locations to investigate the mechanisms and origin of the blastocyst genetic content released to the culture medium during preimplantation embryo development.

Conditions

Infertility (IVF Patients)

Keywords

PGT-A; Trophectoderm; Inner cell mass; Blastocyst; Infertility; In vitro fertilization; niPGT-A; Embryo development; Embryonic cell-free DNA; Embryo selection

Outcome Measures

Primary Outcomes (1)

• Chromosomal status of the embryos

  Concordance of the genetics results between SBM and TE and ICM biopsies samples analysis results.

  Up to 6/7 days of embryo development

Study Arms (1)

Embryos donated for research after an assisted reproduction treatment

Study specific procedures will start only when the potential participant couples have undergone their scheduled IVF/ICSI and/or PGT-A cycles following clinics´ standard practice to obtain blastocysts that will be vitrified. If they accept to donate the surplus blastocysts not used in their reproductive treatment to the current study by signing the informed consent, lab operators will carry out embryo warming and will select the appropriate blastocysts to go through the study protocol procedures (collection of SBM and TE/ICM biopsies). No drugs or medical devices will be used.

Genetic: niPGT-A; Genetic: Multifocal TE biopsies and ICM biopsy

Interventions

niPGT-A GENETIC

After being thawed following the standard lab practice, any donated blastocyst usable for the study will be washed individually to remove any trace of cumulus DNA and will be transferred to a new culture dish with a drop of 10-15µl. Day-5 blastocysts with proper re-expansion after thawing, will be cultured overnight (≈24 hours) before media collection and TE/ICM biopsies. Day-6 blastocysts will be cultured a total of 8 hours after thawing, before media collection and TE/ICM biopsies. On day 6/7, the embryos' media will be collected with an automatic pipette for niPGT-A and additional genetic analysis. The same protocol will be used to analyze SBM and blastocyst biopsies.

Embryos donated for research after an assisted reproduction treatment

Multifocal TE biopsies and ICM biopsy GENETIC

For biopsy, blastocysts will be transferred to the biopsy dish and multi-focal TE biopsies will be performed in three locations related to the position of the ICM. ICM biopsies will be performed following a published protocol provided to the participant centers. ICM and TE sections will be aspirated with the use of micropipettes adapted to a micromanipulation and laser microscope system. For the genetic study of the samples, the same protocol will be used to analyze embryo biopsies and SBM.

Embryos donated for research after an assisted reproduction treatment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Donated embryos to research from patients undergoing IVF/ICSI or PGT-A cycles will be eligible for the study after informed consent signature.

You may qualify if:

• Study informed consent form, approved by the Ethics Committee, signed.
• Any patient with aneuploid or euploid blastocysts from PGT-A cycles donated for research.
• Patients undergoing regular IVF/ICSI cycles aiming to donate surplus embryos for research.
• Embryos from own or donated oocytes can be included.
• Embryos fertilized with donated sperm can be included.
• Only blastocysts with proper re-expansion and good quality after thawing will be included.

You may not qualify if:

• Blastocysts that had not survived to vitrification, that had not re-expanded properly or having poor ICM or TE quality.

Sponsors & Collaborators

• Igenomix: lead

Study Sites (2)

British Cyprus IVF Hospital

Nicosia, 2681, Cyprus

Location

Ventus IVF Center

Nicosia, 99010, Cyprus

Location

Biospecimen

Retention: SAMPLES WITH DNA

Biopsies of blastocyst trophectoderm and inner cell mass. Spent blastocyst media with embryonic cell-free DNA.

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Pere Mir Pardo, PhD

  Igenomix

  PRINCIPAL INVESTIGATOR

• Luis Navarro Sanchez, PhD

  Igenomix

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: January 17, 2025
• Study Start: October 1, 2024
• Primary Completion: November 7, 2025
• Study Completion: November 7, 2025
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CY (2)