None listed
Conditions
Brief summary
The primary objective of this pilot study is to evaluate the clinical effectiveness of our NEST4E non-invasive method for screening embryo ploidy by determining the number of embryos that can that be successfully screened for aneuploidy using the NEST4E rather than invasive biopsy. Aim 1: For euploid embryos the percentage concordance of media sample screening will be confirmed using non-invasive NIPT based first trimester screening as early as 10 week pregnancy. For aneuploid embryos, we will determine the percentage of embryos with concordance by confirmatory trophectoderm biopsy and PGS screening. Aim 2: To determine clinical pregnancy rates and live birth outcomes of embryos that are transferred once screened as euploid. Fifteen patients will be recruited by informed consent to participate in this pilot study to assess the clinical efficacy of our NEST4E non-invasive PGS test to screen their embryos for aneuploidy. Participants will be made aware that their participation in the study is entirely voluntary and that they can withdraw at any point in time. As per standard protocol, patient confidentially will be strictly maintained and their identity will not be revealed in any reviews and reports of this study which may be published. Patients treatment will not be altered in any way and will proceed as per standard IVF cycle, including medications, oocyte retrieval, insemination and fertilization and embryo culture. Patient embryos will be cultured as per standard protocols; G1/G2 Plus media (Vitrolife) overlayed with oil (Ovoil, Vitrolife) in 6% CO2, 5% O2, 37 degrees. A 4 micro litre drop of the spent culture medium will be sampled using PCR grade filtered tips, under laminar flow, and placed into PCR grade 0.6 ml tubes and assessed for aneuploidy as described below. DNA from the culture media sample will be amplified. If this amplification should fail, the embryo will be removed from the trial and will revert to standard care which involves a biopsy followed by vitrification and sample screening. If the amplification is successful, the embryo will be vitrified and the DNA amplified from the media sample used for screening by NEST4E. If conclusive sequence data is obtained, euploid embryos will be made available for transfer.
Interventions
The purpose of this pilot trial is to test a non-invasive Preimplantation Genetic Screening (PGS) method for human embryos. The investigators have developed a method for amplifying cell-free DNA from human embryo culture medium and using Next Generation Sequencing (NGS) to determine embryo aneuploid vs euploid status of the embryo, This technology eliminates the need for an invasive embryo biopsy to perform preimplantation genetic screening. This trial will be conducted at Repromed on 15 patient
The purpose of this pilot trial is to test a non-invasive Preimplantation Genetic Screening (PGS) method for human embryos. The investigators have developed a method for amplifying cell-free DNA from human embryo culture medium and using Next Generation Sequencing (NGS) to determine embryo aneuploid vs euploid status of the embryo, This technology eliminates the need for an invasive embryo biopsy to perform preimplantation genetic screening. This trial will be conducted at Repromed on 15 patients undergoing IVF treatment that would benefit from preimplantation genetic screening. Spent media will be collected by the scientists from the embryo culture dish and used to determine if the embryo is aneuploid or euploid. Each embryo undergoes this method once only on a single occasion, with the exception that if the non-invasive screen does not provide a conclusive result, a trophectoderm biopsy will be reformed on the embryo that fails the non-invasive screen to detect aneuploidy/euploidy.
Sponsors
Repromed
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 53 Years
Healthy volunteers
Yes
Inclusion criteria
This study is a pilot study on fifteen couples (approximately 60 transferrable embryos) to assess the ability of this technology to screen embryos for aneuploidy. Participants will be consenting patients undergoing IVF treatment with PGS at Repromed, 180 Fullarton Rd., Dulwich, South Australia. Participation in the study will be offered to those patients whom PGS in general is discussed as a treatment option.
Exclusion criteria
1. Patients involved in the Donor program (oocyte and sperm) 2. Patients with a known infectious disease (HIV, HEP B, HEP C) 3. Patients using Preimplantation Genetic Diagnosis (PGD) for single genes or translocations.
Outcome results
None listed