Unlocking the Future of IVF: Navigating the Complex World of IVF Genomics
Unlocking the Future of IVF: Navigating the Complex World of IVF Genomics
Date: June 27, 2025
Author: Christine S. Allen, PhD and Nick Murphy, PhD
In the rapidly evolving and adapting field of reproductive medicine, we're at a pivotal and transformational stage. The intersection of IVF and genomics is presenting new opportunities and challenges. In this blog post, we delve into preimplantation genetic testing for aneuploidy (PGT-A), exploring typical modern practice, the rise of whole-genome sequencing (PGT-WGS), and the complexities of utilizing polygenic risk scores. Understanding these technologies and their nuances, setting realistic expectations based on the potential and the limitations of each, and considering socioeconomic and ethical aspects related to insights gleaned from these advances, are crucial for making the most of their potential and fostering open discourse in the field.
Navigating the Hierarchy of Testing
With embryo screening, it’s a paradigm shift to see tests as on a continuum, rather than all having identical insights. As practitioners, when considering WGS our primary focus should be on definitive pathogenic mutations—both inherited and de novo—that cause severe genetic diseases.
When exploring less established genetic states, we have to mindful of variable penetrance and severity, the availability of effective interventions, the strength of supporting evidence, and limitations to how a test was developed. Moreover, ideally as clinicians we want to be familiar with these issues so that we can better counsel our patients, as well select PGT-A and WGS vendors that provide a reasonable balance of informative results and skilled genetic counseling for patients.
PGT-A: The Typical Approach and Its Limitations
For over a decade, preimplantation genetic testing has been the core approach to aneuploidy screening. This technology can be used for larger chromosomal abnormalities in embryos as PGT-A and PGT-M can be used to screen for single-gene disorders in families with known hereditary conditions. However, the resolution threshold for PGT-A is around 5 to 10 million base pairs (5-10Mb), meaning that there can be smaller segmental aneuploidies not detected with typical assessment. The lower resolution of PGT-A is directly linked to its affordability compared to PGT-WGS, which requires at least 1,000 times more reads, adding to cost.
PGT-WGS: Pushing the Boundaries
If knowledge is power, then greater resolution with genetic analysis can provide information that may add value in identifying embryos with lower chances of implantation and higher chances of miscarriage. The balance of insight and economics is evolving, where the human genome project cost several billion dollars a quarter of a century ago, but now exome sequencing can be performed for $100-$1000 readily. For deeper embryonic analysis, PGT-WGS has the potential to be groundbreaking, though proper validation and interpretation remains essential. Proprietary technologies have been developed employing whole-genome sequencing and parental WGS support to screen for inherited and de novo mutations, covering everything from entire chromosomes to single base pairs. This comprehensive approach offers unprecedented insight into the genetic makeup of embryos.
Recognizing that any embryo can have a de novo mutation or an inherited disease, even in 'low-risk' couples, as PGT-WGS advances, it shifts our perspective from, “Ranking euploid embryos so as to improve ongoing pregnancy rates per transfer," to “Ranking embryos likely free of clinically significant genetic variants to improve ongoing pregnancy rates per transfer as well as to lower the likelihood of pathogenic but viable mutations."
The Polygenic Risks
Polygenic risk screening is an exciting addition to the IVF genomics toolkit. The potential of combining clinical risk with polygenic risk to maximize utility presents itself as a benefit. However, the success of polygenic risk models depends on factors such as gender, ethnic background, and family history, where all of these factors play a role in the reliability of the tests offered.
The key difference between Polygenic Risk – Absolute Risk guided by family history and Polygenic Risk – Relative Risk lies in the actionability and interpretability of the results. Absolute risk offers a personalized assessment of an embryo's likelihood of developing certain diseases based on family history, while relative risk provides a general insight into genetic predisposition compared to the population average. As more WGS is performed on our population as a whole, as well as with prospective studies through IVF, the better our modeling and prediction will become. This is important since we have barely scratched the surface of potential genetic understanding and what may be of limited predictive value at this time may evolve to far better insights in the future.
Proposed Hierarchy of Genomic Testing
When using genetic testing to guide effective care for patients undergoing standard IVF, a sequential evidence-based hierarchy of genomic testing should be considered:
- Euploidy assessment: For couples wanting to understand the genetics of their embryos, euploidy assessment can provide insight. Though PGT-A adds cost and does not inherently change the euploidy of an embryo, it can offer value through:
- Accelerating time to conception through not transferring aneuploid embryos.
- Potentially lowering miscarriage rates by not transferring aneuploid embryos.
- Reducing the risk of viable aneuploidies through not transferring embryos identified where this could be an issue.
- Potentially reducing costs in the long run through not transferring aneuploid embryos without a reasonable chance for conception (though this depends heavily on anticipated rates of aneuploidy).
- Shifting self-blame through identification of aneuploid embryos. When an embryo doesn’t implant, many patients blame themselves for non-conception or miscarriage and attribute it to lifestyle factors such as diet, sleep patterns, and stress, when in fact the outcome was driven by aneuploidy. Identifying embryos without reasonable probability of successful conception and then not transferring helps mitigate this issue.
PGT-A should be used judiciously based on each patient's needs and economic considerations.
- PGT-WGS for severe pathogenic mutations: PGT-WGS is a subsequent level of testing relative to PGT-A, offering a comprehensive analysis of an embryo's genetic makeup to identify severe pathogenic mutations, copy number variations (CNVs), structural aberrations, and tandem repeats that cause disease. With refinement through ongoing deeper insight, this in-depth analysis should improve ongoing pregnancy rates per transfer compared to traditional PGT-A or non-testing.
- PGT-PRS (personal risk screening) with family history: Polygenic risk screening guided by family history offers a personalized assessment of successful pregnancies developing certain diseases later in life. This approach offers a targeted evaluation based on the patient's genetic background and familial risk factors. This next level in the hierarchy is a step towards moving from single gene disorders to more complex interactions of genes for inheritance.
- PGT-WGS for variants of unknown significance (VUS's), low penetrance, and high risk from predictive algorithms and PGT-PRS without family history: Addressing the complexity of the human genome, this step considers VUS's, low penetrance variants, and high-risk predictions from advanced algorithms. While challenging to interpret, these findings can offer valuable insights into genetic risks. This step should be approached with caution and nuanced counseling as in many cases, modern data often will provide limited guidance regarding implications.
The Ethical and Targeted Discriminatory Social Risk
As we advance in genomic technologies forward, it is crucial to balance innovation with ethical responsibility. Equitable access and protecting the well-being of future generations will be critical compoents of acceptable use. Accurate results are essential, but they must coexist with socioeconomic and ethical considerations.
We can’t explore advances for genomic IVF technology without considering the risk of social and ethical misuse/abuse. Parents’ seeking certain traits such as high intelligence, physical appearance traits or athletic ability may lead to immense pressure on children, unrealistic standards, emotional and mental harm that may actually facilitate development of mental diseases and/or death[NM1] . Selecting embryos based on perceived “positive” trait selection shifts the discourse to eugenics and may lead to a societal divide where affluent families who can afford a technology seek higher social acceptability of “superior phenotypes and traits”. Exercising economic privilege in this manner can lead to discrimination and exacerbate social inequalities, as access to genetic trait selecting becomes limited to those who can afford it, furthering socio-economic disparities. At the same time, though it is appropriate to worry about these issues, we remain in an era where typically only half of women under 35 have a live birth through a single cycle of IVF (and fewer if older). When many still face the challenge of having a successful conception, for many this will take precedent over more nuanced selection for trait selection, even if selection issues are more likely to be an issue in our societal future.
Conclusion:
As we navigate the growth of IVF genomics, we’re motivated to understand each technology's strengths, limitations, and potential applications by encouraging transparency and discourse. By considering the well-being of prospective parents and their future children, as well as societal and ethical implications, we are better preparing ourselves for IVF’s inevitably complex genetic future.
About the Authors:
Christine S. Allen, PhD, ASRM Technology Committee Member and veteran embryologist who possesses more than 25 years of experience in the area of Assisted Human Reproduction Treatment. She is the COO of EliteIVF and former founder and COO of Cryoforlife automated cryogenics.
Nick Murphy, PhD, expert in embryonic WGS Founder and CEO Genembryomics Ltd Australia and Adjunct Faculty of Monash Pharmaceutical Sciences Dept. Disclosure: Monash Pharmaceutical Sciences Dept is the developer for the Panacea WGS for embryos.
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This episode of Fertility and Sterility On Air covers groundbreaking research on reproductive medicine, including PGTA in donor eggs, BMI effects, and ovarian transplantation. Listen to the Episode
Fertility and Sterility On Air - TOC: Dec 2024
Podcast episode discussing reproductive medicine highlights, including ASRM 2024 insights, meta-analysis integrity, donor ethics, and IVF communication challenges. Listen to the Episode
Journal Club Global: Embriões mosaicos ao Teste Genético Pré-Implantacional para Aneuploidia (PGT-A): o que fazer?
Discutiremos embriões mosaicos ao teste genético pré-implantacional para aneuploidia (PGT-A) View the Video
Journal Global Club From TSRM 2024: Preimplantation genetic testing for aneuploidy in unexplained recurrent pregnancy loss: A systematic review and meta-analysis
Explore the effectiveness of PGT-A in managing unexplained recurrent pregnancy loss, featuring systematic review findings, insights on miscarriage risks, and live birth rates. View the Video
Genetics: Counseling Fertility Couples About Their Evaluation
Caitlin Hebert discusses fertility counseling, the importance of carrier screening, and overcoming barriers for patients while highlighting the role of genetic counseling. View the ASRMed Talk Video
Use of preimplantation genetic testing for monogenic adult-onset conditions: an Ethics Committee opinion (2024)
Preimplantation genetic testing for adult-onset monogenic diseases is ethically allowed when fully penetrant or conferring disease predisposition. View the Committee Opinion
Codes for Embryo Biopsy
When doing a preimplantation genetic test (PGT) biopsy, can you bill for each day a biopsy is performed or can you only bill once for the cycle? View the Answer
The use of preimplantation genetic testing for aneuploidy: a committee opinion (2024)
PGT-A use in the U.S. is rising, but its value as a routine IVF screening test is unclear, with mixed results from various studies. View the Committee Opinion
Journal Club Global: Recent clinical trials in Fertility and Sterility from the Asia Pacific region
Join ASPIRE 2024 for a Journal Club Global on PGT-A and IVF. Learn from top experts discussing recent clinical trial data and pregnancy outcomes View the Video
Coding for an endometrial biopsy/Mock cycle
We had patients request us to bill their insurance for the two monitoring visits and the Endo BX and change the diagnosis code to something that is payable. View the Answer
Journal Club Global: Cost effectiveness analyses of PGT-A
Infertility treatments can be financially burdensome, often without insurance coverage, making understanding the cost effectiveness of PGT-A crucial. View the Video
Coding PGT requisitions to the PGT lab
Do you have any recommended codes to use for PGT requisitions to the PGT lab? View the Answer
Genetics: Is Expanded Carrier Screening the Standard of Care?
Hannah Green, a genetic counselor at NYU, discusses the benefits and limitations of expanded carrier screening, highlighting its impact on clinical practice and patient care. View the ASRMed Talk Video
Genetics - Extra Testing, Passthrough or Money Maker?
Danielle Soltesz of RMA New York discusses the complex economics and ethical considerations of genetic testing in reproductive medicine, exploring costs, patient care, and sustainability. View the ASRMed Talk Video
Clinical management of mosaic results from preimplantation genetic testing for aneuploidy of blastocysts: a committee opinion (2023)
This document incorporates studies about mosaic embryo transfer and provides evidence-based considerations for embryos with mosaic results on PGT-A. View the Committee Opinion
Journal Club Global - Revisiting the STAR trial: The Fellows debate PGT-A
We are excited to host a debate covering the pros and cons of PGT-A and how new technologies should be validated before clinical implementation. View the Video
Indications and management of preimplantation genetic testing for monogenic conditions: a committee opinion (2023)
ASRM has updated its opinion on PGT for monogenic conditions, providing guidance on clinical and technical complexities. View the Committee Opinion
Results Review
What CPT code is most appropriate to submit for Physician Time to review CCS/PGS/PGD results? View the Answer
Sperm DNA Fragmentation
Is there a CPT code for HALO DNA Fragmentation for sperm? View the Answer
ICSI and Embryo Biopsy
How to bill for ICSI or embryo biopsies that occur in different days? View the Answer
Embryo Biopsy
Have any new codes been introduced for the lab portion of PGT? View the Answer
Embryo Biopsy Embryologist Travel Costs
Can we bill insurance for the biopsy procedure? Can we bill for travel expenses? View the Answer
Embryo Biopsy PGS Testing
What codes are appropriate for PGS testing? View the Answer
Genetic Counseling
Does ASRM have any guidance for how to bill for genetic counseling services provided by a genetic counselor?View the Answer
Assisted Zona Hatching
Can assisted hatching and embryo biopsy for PGT-A; PGT-M or PGT-SR be billed during the same cycle? View the Answer
Journal Club Global - PGT-A - Can non-invasive approaches based on spent medium analysis
PGT-A by trophectoderm biopsy aims to select available euploid embryos for transfer. View the Video
ASRM müllerian anomalies classification 2021
The Task Force set goals for a new classification and chose to base it on the iconic AFS classification from 1988 because of its simplicity and recognizability. View the Committee Opinion
Journal Club Global - Accuracy of Preimplantation Genetic Testing for Aneuploidies
Disclosure of sex when incidentally revealed as part of preimplantation genetic testing (PGT): an Ethics Committee opinion (2018)
Clinics may develop a policy to disallow selecting which embryos to transfer based on sex and choose to use only embryo quality as selection criteria. View the Committee Opinion
Best practices of ASRM and ESHRE: a journey through reproductive medicine (2012)
ASRM and ESHRE are the two largest societies in the world whose members comprise the major experts and professionals working in reproductive medicine. View the Committee Joint Guideline