Observational Study to Investigate the Correlation of the Genetic Constitution of the Spent Blastocyst Media (SBM) with the Inner Cell Mass (ICM) and Multifocal Trophectoderm (TE) Biopsies

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Genetic
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Cyprus
British Cyprus IVF Hospital
RECRUITING
Nicosia
Ventus IVF Center
RECRUITING
Nicosia
Contact Information
Primary
Carlos A Gomez De La Cruz, BSc MSc
carlos.gomez@igenomix.com
+34963905310
Backup
Carmen Rubio Lluesa, PhD
carmen.rubio@igenomix.com
+34963905310
Time Frame
Start Date: 2024-10-01
Estimated Completion Date: 2025-09
Participants
Target number of participants: 200
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Igenomix

This content was sourced from clinicaltrials.gov