Use of discarded biological materials for research
Discarded biological materials from assisted reproduction treatments
After all IVF (in-vitro fertilization) procedures, there are left over cells and tissues which are not used for creating a pregnancy, and which otherwise are routinely discarded.
This biological material may consist of:
- Somatic cells (i.e. cells, other than eggs that are aspirated from the ovarian follicles during the egg retrieval process). These include cumulus cells and granulosa cells, which are found surrounding the egg in each follicle. These are removed from the egg or they are floating in the follicular fluid.
- Follicular fluid (fluid from the egg sacs that are aspirated during the egg retrieval process).
- Eggs which failed to fertilize or are abnormal, and therefore are not capable of developing into healthy embryos.
- Abnormal embryos which stopped dividing (arrested) or underwent extensive fragmentation (degenerated) or have been shown to have chromosomal abnormalities and therefore are not suitable for transfer to the uterus or freezing.
- Excess sperm and seminal fluid samples left over after use for egg fertilization.
ALL of these are normally discarded in a biological waste container and then sent to a biologic waste handling facility for disposal.
As an alternative to discarding this material, it could be used by the research laboratory for various research studies which can serve to promote advances in the diagnosis and treatment of infertility, such as improve IVF techniques, or to increase medical knowledge about the causes of congenital diseases, miscarriages and infertility.
How discarded biological materials can be used for research
With informed consent for the use of your biological waste materials for research projects, the consented materials would be used in an anonymized, coded fashion for research projects that have been reviewed and approved by the research ethics board at Sunnybrook Health Sciences Centre, Women’s College Hospital or the University of Toronto. Information from your medical chart such as your age, sex, weight, medical diagnoses and hormonal levels/medication used during stimulation cycles may need to be collected by a nurse or researcher to correlate to sample information, but this information will be coded, and no patient identifier information will be associated with the analysis of biological samples.
Examples of research projects
- We can study the molecules that are made by cumulus and granulosa cells to better understand their role in regulating egg development during ovulation and causes of infertility in some groups of patients, for example in polycystic ovarian syndrome.
- Follicular fluid (fluid from the egg sacs that are aspirated during the egg retrieval process). The follicular fluid contains large amounts of molecules which together with the cells discussed above make up the environment for egg development and maturation. Again, studying the components of the follicular fluid in different infertile patient groups can lead to a better understanding of causes of infertility.
- Excess sperm samples from fertile and infertile men can be used to test various methods of sperm freezing and preservation and improve artificial reproduction techniques. In other research projects, they can be used to look for chromosomal abnormities and genetic mutations in specific patient groups, in order to further our understanding of the process of fertilization and male infertility.
- Eggs that are abnormal can be used to study molecular and genetic factors such as chromosome copy numbers, number of specialized cell organelles (such as mitochondria) that are important for regulating the “energy levels” of an oocyte, or specific genes that are thought to be important for egg maturation and activation during the fertilization process. These can be compared between certain groups of patients, for example those with low fertilization rates vs. normal fertilization rates, to better understand the causes of infertility.
- Embryos that fail to develop properly and arrest at early stages can be used to identify and learn more about factors required for proper embryo development.
How research results are reported
Because our studies are anonymized, the results from a specific patient’s samples cannot be communicated to an individual patient. However, if a doctor feels the results can impact the treatment course outcome or reproductive choices of a patient, in this case the doctor alone could access the code key to retrace the information to a specific patient chart.
Results of completed studies are typically shared with the medical and research community through presentations at local, national and international conferences or through publication in medical and scientific journals. All published material is available to patients upon request or it may be found on the internet. No patient-identifying information will be published; samples are coded and anonymized prior to analysis. The anonymized results of studies will also be posted on the CReATe website & Research Board.