Decision-Making in IVF: Restrictions on PGT-M Positive Embryo Transfers - A Qualitative Study

Objective: To explore how IVF clinics in the United States develop and implement policies regarding the transfer of embryos that test positive for genetic conditions through preimplantation genetic testing for monogenic disorders (PGT-M), those involved in creating these policies, and to identify the key factors influencing these decisions. Methods: We conducted semi-structured interviews with genetic counselors working in IVF clinics across the U.S. Participants were asked about clinic policies regarding PGT-M positive embryos, their role in policy creation, and how patient requests are handled. Transcripts were analyzed thematically to identify patterns in decision-making processes and policy rationales. Results: Findings showed considerable variation in how clinics approach PGT-M affected embryo transfers. While one clinic follows strict guidelines that prohibit the transfer of embryos with pathogenic variants, others allow case-by-case consideration, particularly when patients face barriers to further IVF cycles. Common policy frameworks prioritize transfer of unaffected embryos, with affected embryos considered only after other options are exhausted. Key factors influencing policy decisions included ethical considerations, clinic values, provider discretion, legal and insurance frameworks, and concerns about the child's future quality of life. Despite formal protocols, many clinics still assess individual cases, underscoring the complexity of balancing standardization with patient-centered care. Genetic counselors often serve as intermediaries, advocating for patients while navigating institutional limitations. Conclusion: This study highlights the need for clearer, yet flexible, guidelines on PGT-M positive embryo transfer to ensure consistency while preserving patient autonomy. Greater integration of genetic counselors into policy development and clinical decision-making can support more ethically grounded and informed reproductive care. Key words: PGT-M, positive embryo transfer, clinical decision-making, IVF policy, last chance embryo, patient autonomy, genetic counseling