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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Igenomix
- 入组人数
- 230
- 试验地点
- 2
- 主要终点
- Chromosomal status of the embryos
研究概览
简要总结
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.
详细描述
The study and selection of embryos before transfer is a key step for the success of infertility treatments in assisted reproduction. The current techniques applied are called preimplantation genetic testing of aneuploidies (PGT-A) and are highly sensitive and specific, although they require the retrieval of four to six cells (a biopsy) from an embryo at an early stage of development (blastocyst stage).
Nowadays, the alternatives for embryo selection given to young and healthy women or to couples that do not want to undergo PGT-A are based on studying the morphology and development of the embryos. Unfortunately, these are not reliable methods to know if the embryos have the right number of chromosomes.
A new method called non-invasive PGT-A (niPGT-A) analyses the genetic material released by the embryo to the culture medium (Spent Blastocyst Media, SBM) where the embryo grows in the IVF lab. This genetic material allows for identification of the chromosome number of the embryo. In a previous pilot study, the results of the analysis of the culture media were concordant with the results of the embryo biopsy in 85% of cases.
The current study will analyze the genetic constitution of the SBM and correlate the results of the same analysis on the inner cell mass (ICM) and trophectoderm (TE) cells taken in different locations (multifocal biopsy) to improve our understanding of the mechanisms and origin of the embryo genetic content released to the culture medium during its preimplantational development.
Once this prospective and observational study is approved by the competent Research Ethics Committee, the recruitment and selection of patients will follow. Every potential participant will be asked to sign the study informed consent only after finishing their assisted reproductive treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Blastocysts that had not survived to vitrification, that had not re-expanded properly or having poor ICM or TE quality.
- •Note: No exclusion criteria specific to the patients' background will be considered.
研究组 & 干预措施
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.
干预措施: niPGT-A (Genetic)
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.
干预措施: Multifocal TE biopsies and ICM biopsy (Genetic)
结局指标
主要结局
Chromosomal status of the embryos
时间窗: Up to 6/7 days of embryo development
Concordance of the genetics results between SBM and TE and ICM biopsies samples analysis results.
次要结局
未报告次要终点