ACTIVITY NUMBER: EMBM002

ACTIVITY TITLE: Culture Media and Laboratory Environment

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 4 AMA PRA Category 1 Credits™.   Physicians should only claim credit commensurate with the extent of their participation in the activity.

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: 4 hours

NEEDS ASSESSMENT and IDENTIFICATION OF PRACTICE GAP

The rapid evolution of assisted reproductive technologies (ART) has created an urgent need for advanced, competency-based training in IVF laboratory design, quality systems, and culture optimization. As IVF laboratories become increasingly complex, professionals must be prepared to design and manage infrastructure that aligns with spatial workflow requirements, equipment integration, air quality control, and regulatory compliance, while remaining adaptable to emerging technologies. Many laboratory leaders assume administrative or directorial roles with strong embryology backgrounds but limited formal training in laboratory architecture, regulatory navigation, and long-term operational planning. This gap can lead to inefficiencies, compliance vulnerabilities, and suboptimal laboratory performance.

At the same time, heightened oversight from organizations such as the American Society for Reproductive Medicine (ASRM), the College of American Pathologists (CAP), and the Centers for Medicare & Medicaid Services (CMS) through CLIA regulations has increased expectations for robust quality management systems. IVF laboratories must implement comprehensive quality control programs that incorporate performance indicators, bioassays, proficiency testing, documentation standards, and formal staff competency assessments. However, variability in how these systems are designed and executed across laboratories indicates a need for structured education that integrates regulatory standards with practical laboratory workflows. Without this training, laboratories risk citations, inconsistent outcomes, and compromised patient trust.

Scientific advances in embryo physiology, metabolism, and culture system design further underscore the need for deeper expertise in embryo culture optimization. Embryologists must be able to critically evaluate culture media composition, environmental conditions (temperature, pH, gas concentrations), and laboratory-controlled variables that influence embryo viability and developmental potential. The expanding marketplace of commercial media, supplements, and emerging additives—alongside decisions regarding single versus group culture strategies—requires practitioners to apply evidence-based criteria rather than marketing claims. Additionally, increasing awareness of volatile organic compounds, particulate contamination, and microbial risk highlights the importance of structured risk management and contamination control protocols to protect embryo safety and laboratory integrity.

This educational initiative addresses these intersecting needs by equipping IVF laboratory professionals with the knowledge and applied skills necessary to design compliant infrastructure, implement rigorous quality systems, critically assess culture strategies, and manage risk proactively. By strengthening competencies across infrastructure planning, regulatory compliance, scientific evaluation, and contamination control, the program aims to promote consistent laboratory excellence, optimize ART outcomes, and safeguard patient care in an increasingly regulated and technologically advanced reproductive medicine environment.

EDUCATIONAL OBJECTIVES

At the conclusion of this educational activity, participants should be able to:

1.       Identify the spatial requirements, equipment selection, regulatory considerations, and emerging

technologies necessary to establish and maintain a compliant, efficient, and future-oriented IVF laboratory.

2.       Discuss regulatory requirements about robust quality control systems, including performance indicators, bioassays, proficiency testing, and staff competency assessment.

3.       Discuss knowledge of embryo physiology, metabolism, and culture system design to identify embryo culture media, physical culture conditions, and laboratory-controlled variables.

4.       Identify commercial and in-house media systems, emerging additives and technologies, and group versus single-embryo culture strategies using evidence-based criteria.

5.       Discuss potential sources of contamination, implement preventative strategies, and 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 

Murat Basar, PH.D.: Nothing to Disclose

Kristen  Ivani, PH.D.: IVF Store - Sci Advisory Board (Self)

Salustiano Ribeiro, MS: Nothing to Disclose

Renato  De Mayrinck Salgado, Ph.D.: Spring Fertility (Self)- Full-Time Company Employee

Kurshith Thameen, MS, TS: Reproductive Sciences Medical Center - Full-Time Company Employee (Self)

Speakers/Presenters

Kurshith Thameen, MS, TS: Reproductive Sciences Medical Center - Full-Time Company Employee (Self)

Kimball Pomeroy, PH.D.:  Ivy Fertility - Company Officer (Self); Ivy Fertility - 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 Developers and Reviewers

*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

Speaker/Presenter

Kurshith Thameen, MS, TS: Reproductive Sciences Medical Center - Full-Time Company Employee (Self)

Kimball Pomeroy, PH.D.: Ivy Fertility - Company Officer (Self); Ivy Fertility - Full-Time Company Employee (Self)

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.