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MEDICALLY ASSISTED CONCEPTION An Agenda for Research Report of a Study by a Committee of the INSTITUTE OF MEDI CINE Division of Health Sciences Policy NATIONAL RESEARCH COUNCIL Board on Agriculture National Academy Press Washington D. C. 1989

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NICE: me project that is the subject of this report was approved by me Ga~rerning Board of the National Pesear~ Cavil, whose ~ are drawn frog the councils of me National Aca~ of Science, the National Acaderry of Er~ineering, arm the Institute of Medicine. m e ~ rs of the committee responsible for the report were chosen for their special competencies and with regard for appropriate balance. This report has been reviewed by a group other than the authors according to prCoeJur~- approved by a Report Review Committee consisting of members of the National Academy of sciences, the National Academy of Engineering, and the Institute of Medicine. The Institute of Medicine was chartered in 1970 by the National Academy of Sciences to enlist distinguished members of the appropriate professions in the examination of policy matters pertaining to the health of the public. In this, the Institute acts under both the Academy's 1863 congressional charger responsibility to be an advisor to the federal government and its own initiative in identifying issue= of medical care, research, and education. The National Research Council was organized by the National Academy of Sciences in 1916 to associate the broad community of science and technology with the Academy's purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the pr ~ ipal operating age ~ of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. This project received support from the National Academy of Sciences Basic Science Fund and the U.S. Department of Agriculture (Contract 59-32U4-8-63/R). 2101 Constitution Avenue, N.W. Washingbon, D.C. 20418 (202) 334-3300 T.;hrary of Ins catalog ~ No. 89 - 63252 International Starboard Book Or 0-309-04128-7 Additiorm1 occupies of this Export are available freon: National Academy mass 2101 Constitution Avenue, NW Wa~hi~on, DC 20418 S041 Prints in the Whiter States of America IN 89-08

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LIE OF MEDIATE NIL REMET CECIL ~rd on Agriculture ON 1~ BASIC SCENCE PWN~ONS OF MEDIC ASSISTED ~PrION J. RYAN,* (Taiwan), Professor and Chairman, Dot of ~stetriceand~yr~ology, H~rvard~i~al School, Boston, ~ssac~husetts JOT D. BIT, Professor of Physiology, Harvard Medico School, in, Massachusetts MARIAN D. D~MEWOOD, Assistant Professor, Department of Gynecology and Obstetrics, me Johns Hopkins Mbdi~1 Institutions, Baltimore, ~y1and CLAUDE DESJARDINS, Professor of Physiology, Department of Physiology, University of Virginia School of Medicine, Charlottesville, Virginia NEAL L. FIRST/** Professor of RQ pro ductive Physiology Meat and Animal Science Department, University of Wisconsin' Madison/ Wisconsin GARY D. HODGEN, Professor and Scientific Director, Eastern Virginia Medical School, Norfolk, Virginia ROEEh~ B. JAFFE,* Professor and Chairman, Department of Obstetrics, Gynecology and Reproductive Science, School of Medicine, University of California, San Francisco HOWARD W. JONES, Jr., Professor of Obstetrics and Gynecology, Eastern Virginia Medical School, Norfolk, Virginia STANLEY P. LEIDD,*** Research Associate Professor, Departments of Obstetrics, Gynecology and of Urology, Baylor College of Medicine, Hcuston, Texas . *Member, Institube of Medicine **Member, National Academy of Sciences ***During the study, Dr. Leibo was in the Research and Development Division of Rio Vista International, Inc. . . _ Ill _

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JCN~N VAN I, Professor of Mbl~llarl cellular, are Developmental Biology, Depar~t of Molars Cellular and Devel~nt~ Biology, University of Colorado at BaulHer, Baylor, Colorado EI=RD E. ALPACA, Professor arm Chairman, ~a~t of Logy The Johns Hc~?kins ~ic~1 Ir~i~ions, ~ltinr~re, Skylark STUDY STAFF Institute of Medicine ET.TFN HER, Director, Division of Health Skiers Polity JESSICA lOdNSEND, Study Director CONSTANCE M. PLEURA, Meeting Ra~rteur LACE K. ~ALL, Or, B=rd on Ac~r~culture Institute of Medicine . JAMES; =~;1 Associate Executive Direr 1V

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HE OF is DEFACE SPRY SCOPE OF TO STUDY . . . ~ . . ~ . ~ . e e ~ e e ~ e - I. ~ vr~ F~I]ZATION AND E2~0 ~NSt~X AND S(XIAL C'ON=gNS e e e e e Infertility Contraception Agriculture . Biodiversit~ Primates for Search . ADVANCER IN IRE ~AC:11CE AND SCONCE BASE OF MEDIC~LY ASSISTED ~J(:~;PI'ION e e e e e e e Developments ~ n E~nan In Vitro Fertilization e ~ e e Develo~nts ~n Assisted Cor~tion ~n Fb~-~ucing Arlilll~s e e e e e e e e e - Ga~togenesis and Ga~c . . e e e e e e Fertilization . . ~ . e e e e e e e e e e PreiTrplantation Development e - - - - - e - Implantation e e ~ e e e e e e e e e e e III. ~ 1D }~ ItI IN VI~ I~LlL~ ON AND =13RYO TEtANSt~ e e e e e Ethira1 and Social Issues e - e e e - - - - - e e e O~cher Barrier~; ~ Scientific ~s e e e e RE~E~ A~ AND E~ONS P~ Ag~ . (::oncl~l~ions ar~ ~ations . APE~NDIX A Papers E~es~ at Workshap e II e IV. ~ V ~ PAGE: vii 1 15 15 20 20 21 22 25 25 27 30 45 50 58 66 67 78 86 86 90 ~5

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The committee appreciates the generous contribution of time and knowledge of those who presented papers at the oommittee's workshop at the Arnold and Mabel Beckman Center, Irvine, California, August 21-23, 1988. The thought-provoking papers Contributed to the workshop, and the presence of exceptional scientists and clinicians Stimulated outstanding discussions. The committee gained ~nval`=hle knowledge and insight into issues in research in reproductive and developmental biology that provided the Basis for its deliberations. ~ want to extend the gratitude of the committee to all who attended the workshop. By offering those resources that we all value -- time and knowledge -- the committ^-'s work was greatly facilitated. Kenneth J. Ryan Chairman Committee on the Basic Science Foundations of Medically Assisted Conception V1.

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ICE This report is the ret of a sty by a amni~ee of the Aspire of Medicine (IaM) art the National Prearm ills E~rd on Agriculture. Ibe by its fauna 1984 meeting of an abhor grab convent by the National Academy of sciences to di.~C-= ads of genetic engineering of the human germline. It was nc*~ that because of a policy that, ~ effect, pr ~ ibit ~ the ,~= of federal furls for r ~ rig involving human embryos, the clinical practice of in vitro fertilization and embryo transfer (IVFET) was in danger of outstripping its scientific foundations. Moreover, the United States had not systematically reviewed the recurrent state of knowledge and practice of IVFET. In 1986, the IoM's bard on Health Sciences Policy convened a meeting of experts in the fields of human and animal research, clinical practice, law, ethics, and public policy to consider some of the inches raided at the earlier meeting. This group was asked to advise the IBM on whether it should pursue a spry in any of the areas in which difficult issues had been raised by the practice of medically Misted conception namely, professional, social, legal, and ethics issues, ~ addition to questions of science policy. The group identified several topics to which the IaM could make a substantial contribution. An important result of the meeting of this group was to highlight the .=r-ientific contribution of research relating to animal uses of medically assisted oonception, and the lack of communication between those working to further human clinical [VFET and those working ~ the animal sciences. This seedy of the basic science fcundations of medially assisted conception results freon the Rations made by this group of exerts. SO of the Study A committee was appointed whose membership included individu~ns with expertise in the clinical practice of in vitro fertilization, research in animal and human reproductive and developmental biology, and physiology. The c ~ nits== was asked to examine Jche basic science foundations of medically assisted conception, and develop an agenda for basic research An reproductive and developmental biology that Could contribute to advances in the clinical and agricultural practice of rVFET. This research would also be applicable to other concerns in human and animal reproduction such as mane and female infertility and contraception. Because of limitations on research using human embryos, the committee was also asked to identify animal systems that provide useful models for specific a ~ of medically assisted conception. In addition, the committee was asked to address ways of diminishing barriers to progress in reproductive research and consider ways of fostering communication bean investigators oriented to human clinical questions and those intern In studies of animals. c ~ Vll

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Although the barge ~ the catnip incline consideration of ways of leering barriers to progress in carp, sane of which are cat her legal art ethical cor~xrns, the canine was not ~i~ ~ resolve or ~ ke r ~ erections on such issues. Rap er, it was to confine its deliberations to consideration of ways that scientists ~ ght contribute to the furtherance of the debate on legal and ethical issues related to ~lirO1 ly assisted ~l~ptioa,. The commit ~ e held two meetings. At the first, a plan was developed for a workshop that wound bring together clinicians and investigators to review the status of racist c~ ion in animals and humans, and suggest productive areas for future recur=. He committee carefully reviewed curing Heart di~ct:iorm In repressive science, and select retard areas and .ir~ve~igators to pry them at He workshop. He commit ~ e was aware that it was neither feasible Thor desirable deco provide a comprehensive view of reproductive research. Rather, the committee selected areas of research that show particular promise or describe particularly problematical areas in relation to rVFET. This workshop was also conceived as a major effort in bringing together representatives from the human and animal research worlds to enable them to exchange idea=, enhance their understanding of ways in which they can contribute to each other's work, and together participate in a joint activity that might establish continuing ties. . . a _ . , ~ . _ ~__~ The committees second meeting' after the workshop, was spent in developing this report and its recommendations. Vll'