ACTIVITY NUMBER: EMBM004
ACTIVITY TITLE: Embryo Testing, Biopsy, and Genetics
ACCREDITATION STATEMENT
The American Society for Reproductive Medicine is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.
CREDIT DESIGNATION STATEMENT
The American Society for Reproductive Medicine designates this enduring material for a maximum of 2.25 AMA PRA Category 1 Credits™. Physicians should only claim credit commensurate with the extent of their participation in the activity.
PEER Credits
The American Society for Reproductive Medicine sponsors Professional Enrichment Education Renewal (PEER) credit through the American Board of Bioanalysis. This activity has been pre-approved for 2.00 PEER credits by the American Board of Bioanalysis under course number 66468.
To claim PEER credits:
1. Complete the course
2. Complete post-course evaluation:
a. Fill in all required fields.
b. If you hold a Florida license and plan to claim ABB PEER credits, be sure to include your license information in the required fields at the end of the evaluation.
3. ASRM will submit all learner completions to ABB for issuance of PEER credits. PEER credits are posted within 30 days of completion.
ABB issues PEER credits directly; ASRM certificates or transcripts cannot be used to claim credits with ABB.
Release Date: October 15, 2014
Expiration Date: December 30, 2025
Reviewed and Updated: March 1, 2026
Expiration Date: March 1, 2029
Estimated Time to Complete Activity: 2.25
NEEDS ASSESSMENT and IDENTIFICATION OF PRACTICE GAP
Advances in preimplantation genetic testing (PGT) and embryo biopsy techniques have rapidly evolved, creating an urgent need for clinicians, embryologists, and laboratory personnel to strengthen their understanding of biopsy timing, micromanipulation precision, and the interpretation of increasingly complex genetic results. Although polar body, cleavage-stage, and blastocyst biopsy are all clinically utilized, many practitioners lack updated knowledge about the comparative advantages, limitations, and outcome data that guide optimal stage selection. Additionally, safe and standardized micromanipulation workflows—including zona breaching, cell handling, and tube loading—are essential to minimize harm to embryo development, yet procedural approaches vary widely across laboratories. As PGT-M and PGT-A expand in clinical use, providers must be able to differentiate their indications and understand the benefits, limitations, and risks associated with diverse testing methodologies. The growing prevalence of reported mosaicism further underscores the need for education: many clinicians struggle to distinguish between biological mechanisms and technical factors that contribute to mosaic diagnoses, interpret variability caused by testing platforms and reporting thresholds, and assess the true incidence and clinical significance of mosaic embryos. Because Mosaic Embryo Transfers (METs) present unique challenges in counseling and management, evidence-based strategies are needed to support informed decision-making and optimize outcomes. Collectively, these gaps highlight the necessity for comprehensive training to ensure accurate testing, safe laboratory practice, and confident, data-driven clinical guidance in modern reproductive genetics.
EDUCATIONAL OBJECTIVES
At the conclusion of this educational activity, participants should be able to:
1. Discuss the spatial requirements, equipment selection, regulatory considerations, and emerging technologies necessary to establish and maintain a compliant, efficient, and future-oriented IVF laboratory.
2. Explain regulatory requirements to design robust quality control systems, including performance indicators, bioassays, proficiency testing, and staff competency assessment.
3. Summarize knowledge of embryo physiology, metabolism, and culture system design to critically assess and optimize embryo culture media, physical culture conditions, and laboratory-controlled variables.
4. Explain commercial and in-house media systems, name emerging additives and technologies, and identify group versus single-embryo culture strategies using evidence-based criteria.
5. Identify potential sources of contamination, implement preventative strategies, and execute corrective actions to ensure laboratory integrity and embryo safety.
TARGET AUDIENCE
This activity is designed to meet the educational needs of new and experienced clinicians, laboratory scientists and allied health professionals with an interest in ART laboratory technologies for the evaluation and treatment of the infertile couple.
ACGME COMPETENCIES
Medical Knowledge
Patient Care
Professionalism
SUCCESSFUL COMPLETION REQUIREMENTS
Successful completion of this educational activity requires the learner to:
· View a course overview page containing all CME and disclosure information, including acknowledgment of any commercial support and disclosure of unlabeled use.
· Complete a 10-question pre-exam prior to each module. Learners should note any pre-exam questions answered incorrectly for clarification during module study.
· Participate in the interactive activity: audio narration is synchronized with lesson materials and can be advanced, stopped, or reversed as desired.
· Complete a post-exam after each lesson with feedback of correct/incorrect answers, scoring a minimum of 70% in two attempts.
· Complete the evaluation survey.
· Print certificate of completion.
DISCLOSURES FOR PLANNERS AND FACULTY
Planners
Stephanie Nichols-Burns, M.S, P.H.D, HCLD: Nothing to Disclose
Sarah Ramaiah, PhD, MSEd: Nothing to Disclose
Chevis N. Shannon, DrPH, MBA, MPH, MERC: Nothing to Disclose
Jeffery Hayes, PhD: Nothing to Disclose
Maina Gvakharia, M.D., PhD: Nothing to Disclose
Content Developers and Reviewers
Olga Chaplia, PH.D.: Nothing to Disclose
Yifei Liu, PH.D.: Nothing to Disclose
Cengiz Cinnioglu, PH.D.: NextGen Genetics MSO, LLC - Direct Stockholder (Self); NextGen Genetics MSO, LLC - Company Officer (Self); NextGen Genetics MSO, LLC - Full-Time Company Employee (Self)
Diego Marin, PH.D, HCLD: Genomic Prediction Inc. - Full-Time Company Employee (Self)
Speakers/Presenters
Olga Chaplia, PH.D.: Nothing to Disclose
Cengiz Cinnioglu, PH.D.: NextGen Genetics MSO, LLC - Direct Stockholder (Self); NextGen Genetics MSO, LLC - Company Officer (Self); NextGen Genetics MSO, LLC - Full-Time Company Employee (Self)
(*contributed to the original course only)
Planners
*Susan Gitlin, PhD: Ownership/Stock: Merck; Walgreen Company
*Andrew R. La Barbera, PhD: Nothing to Disclose
*Richard H. Reindollar, MD: Nothing to Disclose
*Nancy Bowers, BSN, RN, MPH: Nothing to Disclose
Content Developer and Reviewer
*Morgan Amick, BS: Nothing to Disclose
*Anthony Anderson, DSc: Nothing to Disclose
*Marlane Angle, PhD: Consultant: Previvo
*C. Brent Barrett, PhD: Consultant: ReproSource Fertility Diagnostics
*Charles Bormann, PhD: Nothing to Disclose
*Bruce Carr, MD: Grant/Research: AbbVie, Medicines 360; Speakers Bureau: Shionogi, Noven, Pfizer
*Marcelle Cedars, MD: Grant/Research: Nora Therapeutics; Ferring Pharmaceuticals
*Grace Centola, PhD: Consultant: New England Cryogenic Center; Cryos International-NY, Central Park Fertility
*Carli Chapman, MS: Nothing to Disclose
*Ri-Cheng Chian, PhD: Other: Cooper Surgical/SAGE Company
*Susan Crockin, JD: Consultant: BMS, Merck, Prometheus; Advisory Board: GSK, CoStim, Aveo; Speakers Bureau: Pfizer Canada, BMS
*Judith Daar, JD: Nothing to Disclose
*Erma Drobnis, PhD: Nothing to Disclose
*Kathryn Go, PhD: Nothing to Disclose
*Kay Graff, MS: Consultant: Steptoe Therapeutics; Employee: Pelton & Crane
*Elizabeth Grill, PsyD: SouthEastern Fertility: Speakers Bureau
*Shalini Gunawardena, RN, BSN: Walgreen's Nursing Advisory Board
*Lee Higdon, PhD: Nothing to Disclose
*Kristen Ivani, PhD: Nothing to Disclose
*Sangita Jindal, PhD: Nothing to Disclose
*Emily Jungheim, MD: Spouse is paid consultant: Abbvie, Genentech, Spectrum, Celgene; Speakers bureau: Genentech
*Levent Keskintepe, DVM, PhD: Nothing to Disclose
*Ann Kiessling, PhD: Nothing to Disclose
*Rebecca Krisher, PhD: Grant/Research: Serono
*Martin Langley, BS: Nothing to Disclose
*Michael Lee, MS: Consultant: Cook Medical
*Bruce Lessey, MD, PhD: Nothing to Disclose
*Dennis Matt, PhD: Nothing to Disclose
*David McCulloh, PhD: Consultant: Infertility and IVF Medical Associates of Western NY; ReproART; Biogenetics Corporation; Employee: NYU Langone Medical Center
*Peter McGovern, MD: Nothing to Disclose
*Yves Menezo, DSc, PhD: Consultant: Nurilia
*Z. Peter Nagy, MD, PhD: Direct stockholder: My Egg Bank; Paid consultant: Origio, Fertilitech; Speakers bureau: Merck MSD
*Mike Neal, MSc: Nothing to Disclose
*Fariba Nehchiri, MSc: Nothing to Disclose
*Sergio Oehninger, PhD: Nothing to Disclose
*Kimball Pomeroy, PhD: Nothing to Disclose
*Thomas (Rusty) Pool, PhD: Other: Auxogyn
*Marc Portmann, MHA, MT: Nothing to Disclose
*Catherine Racowsky, PhD: Consultant: Nora Therapeutics
*Michael Reed, PhD: Nothing to Disclose Lisa Rinehart, JD: Nothing to Disclose
*William Roudebush, PhD: Nothing to Disclose
*Denny Sakkas, PhD: Consultant: Good Start Genetics; Other: Fertilitech, Origio
*Mitchel Schiewe, PhD: Nothing to Disclose
*Ira Sharlip, MD: Consultant: Pfizer, Lilly, Absorption, Vyrix
*Scott Smith, PhD: Product Review: Biocoat
*Amy Sparks, PhD: Nothing to Disclose Laurel Stadtmauer, MD: Nothing to Disclose
*Jason Swain, PhD: Consultant: Irvine Scientific
*Tyl Taylor, MSc: Consultant; Spouse employed: Biodiseño
*Helen Tempest, PhD: Nothing to Disclose
*James Toner, MD, PhD: Speakers bureau: Merck
*Nathan Treff, PhD: Nothing to Disclose
*Tom Turner, MS: Nothing to Disclose
*Matthew VerMilyea, PhD: Consultant: Auxogyn, Irvine Scientific, Genea Biomedx
*Michael Vernon, PhD: Nothing to Disclose
*Diane Wright, PhD: Nothing to Disclose
*Hang Yin, PhD: Nothing to Disclose
It is the policy of ASRM to ensure balance, independence, objectivity, and scientific rigor in all its educational activities. All faculty/speakers participating in this activity are required to disclose any relationships they may have with companies whose products or services could be mentioned, allowing participants to determine the objectivity of the presentations. The content and views presented in this activity are those of the faculty/speakers and do not necessarily reflect those of ASRM. Any discussion of the off-label, experimental, or investigational use of drugs or devices is not allowed. The disclosure statements were reviewed by the CME Subcommittee and the Executive Program Committee of ASRM, and any perceived conflicts of interest were resolved in accordance with the ACCME’s policies and Standards of Integrity and Independence in Accredited Continuing Education.
STATEMENT OF SUPPORT
No commercial support has been provided for this activity..