A trial for the clinical effectiveness of a Non-invasive Preimplantation Genetic Screening (PGS) method for determining the ploidy status of embryos of patients undergoing In Vitro Fertilisation (IVF) treatment that are not suitable for standard biopsy
- Conditions
- InfertilityEmbryo geneticsReproductive Health and Childbirth - Fertility including in vitro fertilisation
- Registration Number
- ACTRN12618001064291
- Lead Sponsor
- Repromed
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 73
1.Any patient for whom PGS is considered as a treatment option will be eligible
2.Patients that have blastocysts’ that are not suitable for standard biopsy and PGS.
Under the current Ethical guidelines on the use of assisted reproductive technology in clinical practice and research (2017), only patients that have already consented to the use of PGT to select against a genetic condition, disease or abnormality will be approached in this study. This is to recognise that the decision to have genetic testing requires serious ethical consideration and is to prevent patients consenting to this trial to access this technology without having considered the full ethical implications.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The proportion of embryos that are unable to be screened using standard biopsy and PGS that can be conclusively screened for aneuploidy using NEST4E. [When a conclusive result is obtained from NEST4E screening (sequencing of amplified DNA from the embryo culture media) for embryos that can not be biopsied.]
- Secondary Outcome Measures
Name Time Method