ASRM PAGES Guidance regarding gamete and embryo donation Practice Committee of the American Society for Reproductive Medicine and the Practice Committee for the Society for Assisted Reproductive Technology American Society for Reproductive Medicine and Society for Assisted Reproductive Technology, Birmingham, Alabama This document provides the latest recommendations for the evaluation of potential sperm, oocyte, and embryo donors as well as their recipients, incorporating recent information about optimal screening and testing for sexually transmitted infections, genetic diseases, and psychological assessments. This revised document incorporates recent information from the US Centers for Disease Control and Prevention, US Food and Drug Administration, and American Association of Tissue Banks, which all programs offering gamete and embryo donation services must be thoroughly familiar with, and replaces the document titled ‘‘Recommendations for gamete and em- bryo donation: a committee opinion,’’ last published in 2013. (Fertil SterilÒ 2021;115:1395–410. Ó2021 by American Society for Repro- ductive Medicine.) El resumen está disponible en Español al final del artículo. Key Words: Sperm, oocyte, donor insemination, donor screening, quarantine Discuss: You can discuss this article with its authors and other readers at https://www.fertstertdialog.com/posts/32311 TABLE OF CONTENTS i. Guidance for ART practices d. Psychoeducational Consultation: that offer embryo donation Embryo Donation with a Directed I. Introduction ii. Donor embryo screening Donor II. Donors indications, screening, and iii. Donor embryo eligibility VI. Genetic screening and counseling— selection iv. Situations in which the donors and recipients a. Sperm Donation gamete source was a a. Genetic Carrier Screening for i. Indications for donor sperm donor, not an intimate Heritable Diseases insemination partner i. Recommended non-iden- ii. Donor sperm screening III. Management of sperm/oocyte tified (anonymous) donor iii. Donor sperm selection donors carrier screening iv. Directed (nonanonymous/ IV. Recipients and their partners— ii. Donor counseling known) donation screening and testing iii. Donor eligibility v. Quarantine of semen a. ASRM-recommended evaluation iv. Recipient counseling vi. Use of fresh semen of recipients b. Family History Screening for b. Oocyte Donation b. ASRM-recommended recipient Non-Identified (Anonymous) i. Indications for use of donor partner screening Donors oocytes V. Psychoeducational counseling—do- i. Recommended donor fam- ii. Oocyte donor screening nors and recipients ily history screening iii. Oocyte donor selection a. ASRM-Recommended Psycho- ii. Donor counseling iv. Directed (nonanonymous/ educational Counseling—Donors iii. Non-identified (anony- known) oocyte donation b. Psychoeducational Consultation: mous) donor eligibility v. Quarantine of oocytes Gamete Donation Recipients 1. Monogenic conditions vi. Requirements of clinics (Oocytes, Sperm, and Embryos) 2. Congenital anomalies providing oocyte donation c. Psychoeducational Consultation: 3. Multifactorial services Gamete (Sperm and Oocyte) conditions c. Embryo Donation Donation with a Directed Donor 4. Chromosomal conditions iv. Recipient counseling — Received January 20, 2021; accepted January 26, 2021; published online April 8, 2021. VII. Legal considerations donor and Reprint requests: American Society for Reproductive Medicine, 1209 Montgomery Highway, Birming- recipients ham, AL 35216 (E-mail: [email protected]). VIII. FDA donor eligibility—question- Fertility and Sterility® Vol. 115, No. 6, June 2021 0015-0282/$36.00 naire, physical exam, laboratory Copyright ©2021 American Society for Reproductive Medicine, Published by Elsevier Inc. testing https://doi.org/10.1016/j.fertnstert.2021.01.045 VOL. 115 NO. 6 / JUNE 2021 1395 ASRM PAGES a. FDA Donor Eligibility Medical Questionnaire Although FDA does not require screening or testing of the b. FDA Donor Eligibility Laboratory Testing recipients of donated gametes, ASRM recommends the evalu- i. Managing laboratory results ation of recipients as described. Other areas where the ASRM c. FDA Donor Eligibility Physical Exam recommendations may be more stringent than the FDA min- IX. References imum requirements are noted herein. Additionally, state re- quirements may be more restrictive than those of FDA, and clinics are encouraged to check with government officials in the state where their practice is located to determine minimum I. INTRODUCTION screening and testing requirements for their state. The use of sperm, oocyte, and embryo donation services has The promulgation of FDA regulations has caused consid- increased over the past several decades (1–3). The erable oversight of gamete and embryo donation, including availability of donor gametes provides individuals and mandatory registration of all assisted reproductive technol- couples who otherwise may not be able to conceive with an ogy (ART) programs with the federal government, federal in- opportunity to build a family. To optimize safety and spections of programs that perform donation, required outcomes, the US Food and Drug Administration (FDA), documentation, and written protocols related to donor American Association of Tissue Banks, US Centers for screening, testing, selection, rejection, and follow-up. Com- Disease Control and Prevention (CDC), and American plete records of all donor cycles, including the documentation Society for Reproductive Medicine (ASRM) have developed of adherence to FDA regulations, must be made available to their own guidance for the screening of donor tissue and FDA inspectors at their request. Federal regulations and recipients. frequently asked questions and answers may be viewed at This document aims to summarize the current guidance the following websites: for donor eligibility determination that has been mandated https://www.fda.gov/regulatory-information/search-fda-gu by FDA before the use of donor oocytes, sperm, or embryos. idance-documents/eligibility-determination-donors-human- Donors are defined as individuals who are not sexually inti- cells-tissues-and-cellular-and-tissue-based-products mate partners of the recipients; donor eligibility determina- https://www.fda.gov/vaccines-blood-biologics/tissue-tiss tion is required for donor sperm, donor oocytes, donor ue-products/donor-eligibility-final-rule-and-guidance-qu embryos, and sperm and oocyte sources when planning to estions-and-answers use a gestational carrier. This guidance also reviews the screening of donors and recipients that has been recommen- ded by CDC and ASRM. Although FDA donor eligibility deter- — mination focuses on infectious risk, the ASRM guidance also II. DONORS INDICATIONS, SCREENING, AND incorporates prenatal optimization, psychoeducational coun- SELECTION seling of donors and recipients, and genetic risk assessment. a. Sperm Donation This guidance for the screening and testing of gamete and Donated sperm for use for donor insemination (DI) or IVF may embryo donors applies to all potential donors in the United be performed with directed (known) or non-identified (anon- States. Because the prevalence of sexually transmitted infec- ymous) donors depending on clinical circumstances. Donor tions (STIs) may vary in other locales, this guidance may not sperm use has increased over the past 20 years (3). be appropriate for other countries or individuals who come to i. Indications for donor sperm insemination. Indications for the United States from other countries. If a donor is deemed donor sperm insemination may include but not limited to the ‘‘ineligible’’ based on the FDA guidance detailed herein, the following: tissue cannot be used for a non-identified (anonymous) dona- tion. However, for a directed or known donation, the ‘‘ineli- The male partner has azoospermia, severe oligozoospermia, gible’’ tissue may be used if both parties are aware of the or other significant sperm or seminal fluid abnormalities. theoretical infectious or genetic risk and consent to move for- The male partner has ejaculatory dysfunction. ward with the donation. Prior failure to fertilize during IVF after insemination with Throughout this document, ‘‘anonymous’’ donors have intracytoplasmic sperm injection. been referred to as ‘‘non-identified.’’ The transition in lan- The male partner has a significant genetic defect or the guage from ‘‘anonymous’’ to ‘‘non-identified’’ reflects the couple has previously produced an offspring affected by a realization that anonymity is decreasing with the prevalence condition for which carrier status cannot be determined or of and access to nonmedical genetic testing. the couple has a strong family history of a heritable disease. Oocyte donation, and thereby this document, does not The female partner is Rh-negative and severely Rh- apply to lesbian couples who undergo reciprocal in vitro isoimmunized and the male partner is Rh-positive. fertilization (IVF), in which one partner provides the oocyte(s) A female without a male partner or with a transmale and the other partner carries the pregnancy. In this setting, the partner. partner does not donate her oocytes. The oocytes should be considered shared between sexually intimate partners ii. Donor sperm screening. There is no method to completely because sperm is shared between heterosexual couples, pre- ensure that infectious agents will not be transmitted by DI. sumed to be sexually intimate. However, the following guidance [Table 1 (4–8)], combined 1396 VOL. 115 NO. 6 / JUNE 2021 Fertility and Sterility® TABLE