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Medically Assisted Conception: An Agenda for Research (1989)

Chapter: Summary/Scope of the Study

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Suggested Citation:"Summary/Scope of the Study." Institute of Medicine. 1989. Medically Assisted Conception: An Agenda for Research. Washington, DC: The National Academies Press. doi: 10.17226/1433.
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Suggested Citation:"Summary/Scope of the Study." Institute of Medicine. 1989. Medically Assisted Conception: An Agenda for Research. Washington, DC: The National Academies Press. doi: 10.17226/1433.
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Suggested Citation:"Summary/Scope of the Study." Institute of Medicine. 1989. Medically Assisted Conception: An Agenda for Research. Washington, DC: The National Academies Press. doi: 10.17226/1433.
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Suggested Citation:"Summary/Scope of the Study." Institute of Medicine. 1989. Medically Assisted Conception: An Agenda for Research. Washington, DC: The National Academies Press. doi: 10.17226/1433.
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Suggested Citation:"Summary/Scope of the Study." Institute of Medicine. 1989. Medically Assisted Conception: An Agenda for Research. Washington, DC: The National Academies Press. doi: 10.17226/1433.
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Suggested Citation:"Summary/Scope of the Study." Institute of Medicine. 1989. Medically Assisted Conception: An Agenda for Research. Washington, DC: The National Academies Press. doi: 10.17226/1433.
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Suggested Citation:"Summary/Scope of the Study." Institute of Medicine. 1989. Medically Assisted Conception: An Agenda for Research. Washington, DC: The National Academies Press. doi: 10.17226/1433.
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Suggested Citation:"Summary/Scope of the Study." Institute of Medicine. 1989. Medically Assisted Conception: An Agenda for Research. Washington, DC: The National Academies Press. doi: 10.17226/1433.
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Suggested Citation:"Summary/Scope of the Study." Institute of Medicine. 1989. Medically Assisted Conception: An Agenda for Research. Washington, DC: The National Academies Press. doi: 10.17226/1433.
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Suggested Citation:"Summary/Scope of the Study." Institute of Medicine. 1989. Medically Assisted Conception: An Agenda for Research. Washington, DC: The National Academies Press. doi: 10.17226/1433.
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Suggested Citation:"Summary/Scope of the Study." Institute of Medicine. 1989. Medically Assisted Conception: An Agenda for Research. Washington, DC: The National Academies Press. doi: 10.17226/1433.
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Suggested Citation:"Summary/Scope of the Study." Institute of Medicine. 1989. Medically Assisted Conception: An Agenda for Research. Washington, DC: The National Academies Press. doi: 10.17226/1433.
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Suggested Citation:"Summary/Scope of the Study." Institute of Medicine. 1989. Medically Assisted Conception: An Agenda for Research. Washington, DC: The National Academies Press. doi: 10.17226/1433.
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Suggested Citation:"Summary/Scope of the Study." Institute of Medicine. 1989. Medically Assisted Conception: An Agenda for Research. Washington, DC: The National Academies Press. doi: 10.17226/1433.
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SUM, mis stay was p~*ed by a cordon that, Muse of a policy that ~ effect prohibits the ~~~ of federal furls for ~ involving human embryos, the mini practice of in vitro fertilization arm embryo transfer (IVFE:r) was pi to the limit of its scientific formations. In avocation, there was a perception that animal science had made substantial progress in the development of rVFET but, because of a lack of communication among those working to further human clinical IVFET and those working in the animal science area, the knowledge developed in one sector was not being conveyed to the other. AS a result progress in each sector was seen as being slowed. An Institute of Medicine committee was appointed to examine the Chic science foundations of medically assisted conception, to develop an agenda for basic science research that could contribute to ads in the clinical and agrialltural practice of IVIES, to sagest aniJre1 systems dot provide useful m~els for pacific research areas, ~ identify ways of diminishing barriers to pr~ess, and to red ways of bringing together the veterinary and human repr~ti~re research workers. lhe oer~tarpi~r~ of the s ~ y As a workshop at which clinicians and investigators reviewed the stab ~ of assisted conception and The relater basic research in humans a ~ animals, and suggested productive areas for future research. This workshop brought together representatives from the human and animal research worlds to enable them to exchange ideas, enhance their understanding of ways in which they can contribute to each others work, and participate in a joint activity that ~d establish contir~uir~ ties. Social Concerns what Can be dress By IVFET Joseph dirt at Chid forward the frontiers of helically assists conception has the potential to provide benefits beyond the limited nabber of couples whose infertility may be solved by IVES. m ere are expectations that such research would enable practitioners to identify genetic defects in embryos without damaging them, and to determine the sex of embryos without damaging them, so that those with sex-linked genetic diseases can be identified at a very early stage. Major areas to which advances in basic reproductive biology would make large contributions include: — 1 —

0 Infertility. Me magnitude of the problem of human infertility is reflex by the number of wan with "impairs flits" 4.4 million or 8.2 percent of In of childbearing age in 1982 (National Center for HF1A1th Statistics, 1985~. E'y one estimate, Ire than half of the 4.2 million warren so have been surgically sterilized for Ron oontrac~ptive reasons, arm half of Me 4.4 million s~ibf":ur~ In wculc} like to He pregnant. Ore, ox million Warren between He ages of 15 arm 44 who were or had been married Or at let one Spiral visit for infertility in 1982 (fixes and] Pe~ault, 1986). Alpha data coot describe He emotional toll of infertility, the nications Apia are beginning to portray sax of the distress. He lengths to which cables will go in attempting to conceive arm the formation of nationwide suborn groups for c~ilcil~= people are indicators of ache pain of childlessness. Al~h Iv~r ~ a solution for only limited ~ of infertile Apples, r~rdl Hat advarx:~ the practice of IVEFT also has ache pcrtential of advancing cipher fond of infertility treatment. Numercus infertility treatments exist, including education to give Ccupl~= sufficient knowledge of reproductive biology, surgical repair, artificial insemination, and the use of drugs to induce ovulation. Two major new technologies are [VFET and gamete Any afallopian transfer (GIFT). mese are complicated technologies. m e simple description that follows will facilitate understanlinq of the research agenda developed by the committee. For IVFET, eggs are removed from the woman either during a natural cycle or after growth and maturation of occytes has been stimulated by such drugs as human Mensa gonadotrophin. This latter method has the advantage of allowing more than one oocyte to be harvested. The egg is placed in a petri dish together with washed sperm that have been treated to ensure capacitation. If fertilization is achieved, the process of cleavage starts, and somewhere between the 2- and 16-cel1 stage, the embryo is transferred to the uterus. Pregnancy is established when the developing embryo implants itself into the wall of the uterus. Mare than one embryo may be transferred to the uterus. For GIFT, growth and retrieval of eggs are performed in a manner similar to that used for [VFET. Semen is collected and placed in a catheter with the eggs, and they are then transferred to the fallopian tube. Fertilization takes place in viva. Sometimes donated sperm, eggs, or fertilized zygotes are used in assisted conception. For example, excess zygotes collected fmn a patient urxiergoing IVAN can be fertilized and implanted in a recipient uterus that has been sync~zed with the donor's cycle. O Contraception. hi in the - -tic science that weld ingrate the clinical practice of ~~;cist~ Luxation wcAllcI, at the Sam tin—, help in the search for better contra~cive teleologies. Despite widespread use of such ~ntra~ptive methods as sponges, surgical sterilization, intrauterine devise, and birth Sol pills, there remain unresolved

problems of safety are efficacy. ~ sear for implored for of contraction ~ sparred not only by the desire of individuals to gain conch aver their repressive lives, he alto by the social cost of up prelacies arc the problems caused }fly fast~gr~ir~g populations in Injuries unable to provide an Hate stanzas of living for the present predation. o Agriculture. He application of Hiss connation Unit; has made rapid inroads in ache tic cape ir~try. Artificial insemination is the norm, with 70 percent of dairy cows oonaeivir~ In this Urn In 1985. In IF~c than ~ cheep;, a n~timillion clollar IVES bovir~e ir~cry has c~velc~. Abet 25 pert of embryo transfer In 1984 wet of frozen embryos. Artificial ~r~tian has rat In genetic i~prov~rents in daisy cattle that have crabbed mill production per can In thirty years (First, Crister, are P0l, 1985~. Embryo transfer Homology ir~reases the rate of prounion of Valerie cows. Ire auction of new r~r~uctive ~nologie~ to Charge the pinion of foc~-pr~x3ucing animals has the potential for Inhering the cost of food and Sickening the process by High anions genetically suite ~ cliffi~t clime ~ ~ ~~ 0 Biodiversity. Is in reproductive t~rx)1ogies may sustain biodiversi~r by improving He r~uctive efficiency of ~ng~ Elegies. O Primates for Prearm. A limited ~ of primal—C are In captivity and available for z~`, art there is a possibility Cat He capture of more may be hall becalms= of Urn: for the future of the species. It will be increasingly important to maximize the r~pr~tive capabilities= of the pry;: available to science. Barriers ~ Ens in In Vitro Fertilization and Embryo Transfer since the birth of Twin Brown in E ~ lard in 1978, in vitro:, fertilization with embryo replacement has become an established method of treatment for certa ~ types of infertility that do nck respond to alternative methods of treatment. However, the chances of Quoters in IVF are relatively low. In 1985, 14.1 percent of stimulation cycles resulted in clinical pregnancies. In 1986 this figure rose to 16.9 percent (Fertility and Sterility, 1988). But, the proportion of women entering treatment who attain a live birth is far lower ~ only 8.9 percent of oocybe retrievals ended in live birth (Journal of the American Medical Association, 1988). Why are the ~~= for suro~cful IVFET so low? The state of clinical practice of IVFET today is limited by lack of knowledge of some of the basic reproductive biology involved. This is caused, In part, by the many ethical questions raised by research in pursuit of the needed information. Difficulties in resolver these issues have cat the reseat h to be deprived of federal f~i~. — 3 —

Ethical arm Social Issues Sare of the ethical or social ~c that arise fray the variants form of mist correction are unrelated to decisions a}xxIt the promos of rearm. E~nples of these are ~i~ am the promotion of the rights of gamete donors, g~tati~al parents, and social par~ts; the Rip of cryc~preserved mbryos; arm the sale of gamy= arm embryos. sane ethical question have a dim Ring on i, and have had important consumers; for ache few of ~arch. me major questions fees on ~ sta—~= of the embryo at each stage of itch develc~rent. Hcm ache embryo ~ rearm dictate that Is Orally arable to do to it. At one end of this ~bn~ of Fought Is me position yawn by the Pecan Catholic Churl. me Vatican's Suction on Pi for mean Life state that "freon the first at of its existence until birth . . . no moral distinction is oonsider~ between zygotes, pr~ryos, erdbry~ or fetuses" (cited ~ Fertility are Sterility, 1988b). Therefore, the absolute sanctity that is accord to p~-nat~l human life begins with the zygote. Ihis arc makes it impossible ~ discard spare embryo or use them for Ryan Arm. At the cipher end of we Rho Is me position that an embryo Is merely biological material like any other group of living cells. The special value that might be attached to that Merriam rats frog the Rations or aspirations of others (Office of Ethnology Assessment, 1988) . Midway between th~;c too positions is one that holds Bat "~e hen embryo is entitled to profane respect; but this ~c does no r~ssarily ~a~ the full legal arm ~~ rights acrid to a person" (Department of Health, Education, arm Welfare, 1979~. Holding this position, the Elite; Advisory Bard (established by the ~r~nt of Health, Education am Welfare (~) in 1979) concluded that rearm was actable on embryos up to 14 days after fertilization. the Feds Goverrment arm Embryo drub Policy conic rewarm on human subjects has Ben sickly evolving singe the 1960s. A sty gnmp was convened atNIH to develop guidelines' arm a National Advisory Fission on Health Science arx] Society was prod by Senator Walter Mondale ~ 1968 to examine develc~nts in Rival regears. Follcxving reports of the infants Gee syphilis experiments, mEW Rae Bat is establish a ~rrra~t bcxty to regulate federally furred Rae using hogan subjects. In the 1970s the abortion issue ~ lime ~ the issue of embryo reseat. After the Roe v. Wade Schick legalized abortion User Canaan conditions, concern develops that wan weld be pressure into having abortions arm the awe of aborts ~ryo6 might aver. In 1974, Me fevers government cravat the National fission for the Lion of — 4 —

Human Subjects (P.L. 93-348). Until this commissiQn reported to Congress, research on the living fetus was prchibited unlay= it was used to help that ferric survive. In 1975, DHEW issued regulations hasps on the findings of the commission. Id-== regulations did not cover embryo research. The commission also recommended establishing an Ethics Advisory Board (EAB) to review requests for research on embryos and in vitro fertilization. However, in 1980, the Secretary of CHHS allowed the EAB charter to expire. mus, no research could be approved, and federal funding of embryo research was de facto prohibited. As a result, embryo research has relied on private funding from patient care revenues, pharmaceutical companies, and university budgets. Since 1985, efforts have been made that, if mYY~es~ful, ~ ght establish some rules under which embryo research could proceed. However, the chances of such an outcome ~ the near future appears to be slim. A Congressional Biomedical Ethimc Board, composed of six senators and six representatives, has been appointed. This group established a Biomedical Ethics Advisory Committee. In 1988 the Department of Health and Human Spavins at its intention to revive the Ethics Advisory Record and publish a proposed tar en A final Farber is awaits. Domestic ~ Foreign Decisions Concerning Embryo Research The two professional societies ~ the United Stats that represent the physicians most involved in hymen IVFEr have considered ethical questions abort the practice of IVES art - 3ryo research. In 1986 the Remittee on Ethics of the American Cabs - e of C~etricians and Gynecologists (AaDG) (1986) issued a statement that acl~ledged the ethical issues pos ~ by the creation of embryos outside a uterus, the dilemma of surplus embryos, and the acceptability of research using early human embryos. The ACOG committee recommended that human embryos should be used only if nonhuman embryos could not provide the needed knowledge. It also recommended banning resee rch on embryos that had reached the age of 14 days. The American Fertility Society (AFS) also issued a report in 1986, approving experiments on embryos up to 14 days (Fertility and Sterility, 1986~. A year later, after consideration of the Vatican's Instruction for Human Life in its origin and on the Dignity of Procreation, issued by The Congregation for the DccUrine of Faith, the ADS issued another report. This report stated that progressive degrees of respect are *ue with progressive development of embryos, and that experimentation can be justified and is neat if the human condition is to be improved (Fertility and Stern ity, 1988b). The government of the United Scats=, since 1979, has not followed the lead of nations that have systematically examined issues related to human [VFET. Since 1979, at least 85 statements have been prepared by — 5 —

cc~nittees representing at least 2S vestries. Fair A~alian Remittee; fat r~ on early (prei~lalTtation) embryos to be ethically urm~:able. Eleven canmi~ees arrived at least saw kinds of early embryo r~. Six of these adept sub relearn only oar embryos left aver frown clinical activities. Five c~ni~ee sta~:s (include ache 1979 MEW Ethics Advisory army wed allay the <ration of embryos for r~ I. A1~ the majority of committees favor limiting rearm on er~ryo6 to up to fin days, Me committee allied it only to seven days, are one curly thence ~ first cleavage (Walters, 1987~. In son, n~s gas have wrapped with questions rala~ to ethical problems of embryo or fetal redry. Sare have base fir conclusions on religious tenets, sane ~ an interpretation of scientific Urge, same on a mixture of both. Other Barriers ~ Scientific Ens Cipher factors besides ethical considerations are slawing the progress of heat in areas of reproductive biology relay to assist conception. Deficiencies in the Science Base Pawn; presto at the cammi~ee's workshop art the reseal agenda densely fixes that workshop indicate deficiencies in the scientific urxierpinnir~s of reproductive biology, art identify many areas in whiffs further r~r~ efforts ~1d maim major contributions to improvements in medically autism con ~ ion. The deficiencies are on three levels: basic science knowledge; knowledge needed to improve the technologies being and for medically assisted conception, such as cryobiology; and knowledge needed to improve both human and animal clinical practice of rVFET. research Funding Approximately $155 million annually is spend on research in reproductive process es. Federal agencies are the principal support for research. In 1986 they provided $109 ~ llion for research in reproductive proc sees (National Institutes of Health, undated). Federal funds for research relating to agricultural animal reproduction are available frill the U.S. Department of Agriculture. Funding for basic research in reproductive biology is undoubtedly constrained by the lack of vocal and foamy advocacy groups. Tacking such a voice a major increase in federal support is unlikely. Lack of Communication Among Researchers Dimension with the scientists and clinicians at the committee's workshop revealed an underuse of available mechanisms for communications among the individuals involved with various aspects of research in reproductive biology - heroic, clinical, animal sciences, etc. Also revealer was a desire for greater — 6 —

communication to allow cross-fert~ ization of ideas and development of ongoing relations hips among investigators pursuing similar approaches to problems. sources of Research Material for Experiments with Humans and Other Primates The committee's workshop provided many excellent examples of instances in which information about reproductive physiology derived from animal models has keen 1,CPfU1 in unlerstandlnq human physiology. However, animal mantis cannot suffice for investigating all central questions; progress ~ some areas requires the ,~== of human tissue. An example of this is investigation of reasons for developmental failure of human embryos. Although specific primates are good masons for some aspects of human reproductive physiology, there are only a limited number of monkeys of desirable species ~ captivity and many of them are presently being used for AIDS research. A workshop was held August 21-23, 1988 at the Arnold and Maker Beckman Center in Irvine, California. Overviews of the experience gained by the clinical practice of rVFET and of the practice of aniseed conception in food-prc~ucing animals directed attention to unanswered questions that will ~ basic science research for their resolution. These questions reflect important gaps in our knowledge of the biology of all the stages of reproduction from the develcpment of male and female gametes to the process of embryo implantation. The topics listed below are areas ~ which further research was recommended by workshop participants and committee members. Work ~ thence areas is expected to increase understanding of the biology of reproduction with the hope That increased knowledge will eventually lead to improvements ~ the practice of IVFET in humans and ckher animals, or to advances in oontracepkion. Rr search areas are listed here in summary form and apply bath to lower animals and human beings unfed= specifically noted. me complete summary of the workshop is contained in Chapter Two of the full report. chic Science Male Gametogenesis o Definition of the role of cell adhesion molecules in interactions between Sertoli cells and developing sperm cells. O Understanding the function of differential protein synthesis in different stages of sperm develcpment. — 7 —

o Determination office role,of pa~crine factors incl~i~ fibr~last grew factor, Stalin C, epidermal grchrth factor, and ir~rl~kin-1 on the ~velc~: arm cliffer~iation of male gamete. O Structural analysis to identify normal arm abnormal Opens and the develc~rent of marker'; for a~r~1 sperm. 0~ Ur~tar~ir~ of we bi~istry of Berm capacitation. Fee Ga~genesis o Analysis of the effects of ~vvulation or hormonal stimulation p~x:ols on He develc~nt and maturation. His work Child also ermine cliff~rKxs been species. O Develc~nt of ways to marry of; in vitro. O IrIvestigation of ways to naturally stimulate Byte and follia~ar development. O Investigation into the biodh~nistry of Tneiotic arrow and the factors, such as cyclic Am, purines, Scion, and ma~ration-prcr~ing factor, that may mediate this process. o Devel~nt of ways to produce or synopsize hones frmn non-h~nan primates to be used in ovarian stimulation. O Definition of the role of Croatian estrogen In ocx~e maturation and ovulation are the interactions been estrogen and paracrine factors incl~ir~ fibrdblast ant ppidermal Huh factors, insulin-like! growth factor, transforming growth factor, and ir~ibin. O Definition of the point at which offs become sensitive t:o factors that influence their development. O Elucidation of ache pro that underlie oocy~ce depletion, to determine By cables are lost at a predictable rate ~roughaxt life. O Investigation into ways to augment natural hormone rml-A-~. o Investigation into the biochemistry of protein synthesis and modification in ovarian calls. Fertilization . 0 Investigation into the biophysics of m=1l membranes as it relates to sperm and egg interactions at fertilization. — 8 —

0 Confirmed irnrestigation to identify the germ; for zone proteins in variants sp~ies, especially hogans. O Earth delineation' of Me role of zone proteins, Medially ZP2 are] ZP3, In Sperm birding. O ~star~ of ~ bi~istry of the modification of zeta proteins in preventing popery. O Elucidation of Me Mogul ar mirier of antibody formation to zone proteins arm ~ r Forcible ale in c~r~tra~ive strategies. O Definition of Me bi~emi~a' Mania of the cortical reaction the egg arm the effects of this reaction on zeta proteins. O ~ination of the ~ysiologi~a1 significant of germinal vesicle breakdown and the bi~ist.~ of sperm urinate decorxiensation. o Definition of the molecular events associated with formation of the male and female pronuclei. O Definition of the molecular events *tiring zygote formation and the first cleavage. Preimplantation Deve~gement o Definition of The metabolic requirements of early embryos at different stages. - 0 Determination of embryonic gene expression. o Assessing the potential of individual embryonic cells and defining the point at which embryonic calls are committed to particular fates. 0 Identification of substances produced by early embryos that signal changes in the uterus prior to implantation. O Improvements in embryo multiplication and embryo splitting, especially for food producing animals. Implantation o Definition of the biochemical events that make the uterus permissive to implantation. _ 9 _

o Definition of the factors rearm by embryos that cause trial changes at the since of i~plar~ation. O Identification of the role of ~ry~r~ factors suppressing the ire responses of me Other. O Isolation am analysis of Stan release by Serial delis and ~ r effects oat IBM;. O Continue work with In vitro navels of Man inplantati~ to sway the biochemists and ~i~ of ~ry~anetrial interactions, especially the rule of extra~lular matrix proteins arm the bic~nistry of to - `iblast invasion of ~ er~a~rium. T~ic~ ~ 0 depraved cry~p~servation te~niq~, incoming freezing arm thawing protocols for eggs arm embryos. o Improved resolution of ultrasonography for localization and nonInvasive harvest of oocytes, eggs, embryos--would have particular usefuinRss for non-human primates and food prosaic mg animals. O Development of new couture media and methoic for in vitro maturation of oocytes. O Development of safe methods of biopsy of early embryos for pre~mplantation diagnosis of genetic dic-~cpc. Clinical Research Opportunities lee founding areas are those In which a ooordinated data collection effort across IVAN centers weld help improve the quality arm success rate= of IVES nationally arm, possibly, internationally. O Evaluation of hormonal stimulation protocols in teens of Or of oopytes }vested, quality of oocytes, arm rate of fertilization s~c~cc . o Documentation on the incident_ of abnormal implantation rates in IVFET practice and correlation of incidence with particular stimulation Pal ad. O Collection of information regarding the incidence of abnormal zygotes and embryos, failed fealty ization, and developmental arrest of embryos. O Analysis of data pertaining to synchronization of embryonic stage with endcmetrial stage and development of methods to improve synchronization. o Collection of information on sharing of spare eggs and arres teed embryos for research purposes. — 10

Elusions and ~atiorm Developing Beards Polisher Tack of a Mania for dealing with ethical clisag~ement aver ache use of embryos ~ losers he sled the rate of progress In ram }by, In effect, placing a moratoria on He `~ of farad furls for eight year';. This h?= had undesirable results: Be human clinical practice of Iv~r is To effective En it might have been had reseal pi at a fester pace; other socially~irable goals such as improved con Erosion, better nines to preserve endangers Bier;, and Are c=;t-effective methods of producing food have develc~ed at a pace sicker Can c~timal. me recent aft of the Biro—teal Advisory C~nitt~ by the Bic~i~a' Ethics Bard, to report to Era by November 1990 cm embryo issues, cc~c3 be a step End a solution. Ike cranmi~ applaud the intention to revive ache Ethics Derisory Board of lit of Health and Ran Ser~ri~c to rule on the ethical adoptability of red relating to human embryos, Rich is Bill before federal furring of sum a rearm Grit can be consign. However, until these go ~ fully fictional and straw evicler~ of pros, their impact must remain In question. If these groups can an leadership roles In resolving the difficult issues of reproductive r~, arx] develop guidelines for ~ a ~ that are teas ~ on information provided by sci ~ x, and on concepts that a ~ ethically a ~ ble to society, research in reproduction will be able to move forward. But if these grcup6 become paralyzed because of political considerations or an inability to develop a framework for the resolution of differences of Opinion, another organization should take over the role. The committee recommends that, if the grc ups currently being formed fail to come to conclusions concerning embryo am fetal research. a non-govarn=ental organization should be established to develop guidelines for embryo and fetal research that are based on the Ret advanced knowledge that science can her. and with scrims consideration of ache expr~d values of society. Ihe group shculd be cc of individuals with expertise in the relevant scientific disciplines, representatives of Be lay public, and exerts In the legal, ethical, and social issues. He organization shculd be housed an institution that would allow it to c~rxtuct its deliberations free from any undue pressures fern political and special interest cargos. A Eel for such activities can Authority of Goat Britain. found in the Voluntary Licensing — 11 —

Relic science Formations me rammer arm range of topics include in me relearn agenda indicate the exciting po~ial for Rive scientific exploration. me cammi~ee believes At fatal Farm ~ enhance me Eric scier~e formations of repr~:ive biology ~d be stimulated and Sparta. this incur sties of human beings, laboratory animal dels, and foa3=pr~ducing animals. ~ e kr ~ ledge that ~ id be generated is fundamental to an understanding of how to reverse infertility, to new approaches in the area of contraception, and to increasing the world's food supply. It is important that male as well as female reproductive biology be studied and that investigators make lace of some opportunities that are largely ignored tc day. mese opportunities occur as a result of clinical activities as well as research activities. me ccmmitt== reccrmen~s that a vigorous program of funding for a basic science agenda in reproductive biology be maintained in a coordinated fashion by an appropriate office In the National Institutes of Health. Applied Research Research needs to be stimulated cone rning technologies And In medically assisted conception in food producing animals and in human beings. Lack of support in these areas is leading to inadequate scientific underpinnings for safe and effective clinical ~pn~ctice. Art example of a technique used, but not carefully evaluated for possible detrimental effects, is freezing eggs or zygotes. Further experiments should be conducted to Chic the effects on safety and viability of this technology which is standard practice in many [VFET clinics. Other areas of technology that need to be developed include 1~= invasive ways to retrieve oocytes, ways to mature oocytes in vitro, and ways to accpcc the quality of spermatozoa or eggs to be n=~ for fertilization. The committee recommends that applied research into technologies used in medic~lly-assisted conception be undertaken to provide a firm foundation for the safe and effective practice of in vitro fertilization and embryo transfer. Such applied research should be coordinated by the appropriate office at the National Institutes of Health. Clinical Research Opportunities Perhaps the most obvious mussed opportunity is the failure to learn from the diverse experiences of the approximat=1y 160 clinical programs that provide IVFET. In addition to scientific questions, there are _ ~ _

questions to c30 with the organization of clinics and ~e ~ of Inures, Me answers ~ which ~d enable practitiar~; to work Ire effectively, arm polity Mars to make decisions on the Isis of the best avail able information. Clinical IVFEr chances can prc~vide unique Opportunities for important s ~ ies. For example, human oo ~ ; ~ at fat to fertilize in vitro cculd be used to investigate the pbencmenon of fat ed fertilization. Research that seeks to understand the basis of reproductive failure, and its relationship to hyperstimLlation should be encouraged. Coordinated studies utilizing the Marc of material and experience frmu rVFET centers could begin to answer these and other questions. me committee applauds the activities of the various prof-=cicnal societies that have issued n ~ binding stat~n~cs about the quality of practice of IVF. The American Fertility ~ ciety has also provided a voluntary registry for centers. The committee believes that a mechanism is needed to monitor and evaluate clinical practice so that existing information that is relatively easy an] in expensive to collect can be disseminated. This would enable clinicians to build on the broadly heaps experience of the community and help ensure that patients have access to information about developments in IVFET and to well-informed physicians. The committee recommends that a mechanism for mwlti-centered data collection be established to monitor and evaluate human and veterinary practices of medically assisted conooption in order to imp ~ e the safety, effectiveness, and quality of clinical practice. A cooperative group composed of the Mel ~ nt profe~ciona, societies should be established to fund and initiate data collection under the direction of an inter-society council composed of representatives of each participating organization. Improving Communications The IBM Workshop on Medically Assisted Conception brought together researchers from basic science, clinical practice, and animal sciences. The resulting interaction was viewed as extremely helpful by investigators face each of these communities. The committee recommends that a mechanism (or multiple mechanisms) be found for fostering continued communication between researchers in diverse areas of reproductive science. m e initiative should come both from NIH research ado mistrators who cculd sponsor additional workshop opportunities, as well as from the professional societies, either individually or through an ~ntersocie~y council. — 13 —

REGENCY Anerican college of Obstetricians arm Gemologists. 1986. Emit Issues ~ mean In Vitro Fertilization arm Embryo Placerent. CXamni~ on Ethics AGOG Unit Opinion Namer 47. Walton, D.C. t of Walsh, Formation and Welfare. 1979. HEW Short of Involving Oman In Vim Fertilization art Embryo Transfer. Part arm Oor~clusions. May 4. Ship, D.C., U.S. Gcr~rerrment Printing Office. Fertilizer and Sterility. l98Sa. Anvils Fertilizatior~ryo Transfer In the United Static: 1985 arm 1986 Results flora the National IVF/Er P - ivory. 49(2) :212-215. Fertili~rar~Sterili~r. 1988b. Ethical considerations of the row r~pr~ctive theologies. py the Ethics Remittee (1986-7) of the American Fertility &'cie¢,r In light of Instruction on the ~ t for Human Life in its Orig ~ and on the Dignity of Procreation issued by the Congregation for The Doctrine of the Faith. Feb;49(2 Sup pi 1):I-7S Fertility and Sterility. 1986. Ethical Considerations of the New RRprc~uctive Technologies. The Ethics Committee of The American Fertility Society. Sep;46(3 Suppl 1):IS-94S. First, N.L., Critser, E.S., and Robl, J.M. 1985. Boving Embryo: Development, Cloning, Sexing and Transfer of Genes for Immunology of Reproduction and Contraception, P. Talwas, ed. FUsevier, 1985. Fuchs, V.R. and Perreault, L. 1986. Expenditures for Reprc~uction-Related Health Care. Journal of the American Medical Association. Vol. 225, No.1. January 3:76-81. Journal of the American Medical Association. 1988. IVF Registry Notes more Centers, More Births, slightly Improved Odds. 259~13~:1920-1921. National Institutes of Health. Undated. Inventory and Analysis of Federal Population Research. Fiscal year 1986. U.S. Department of Health and Human Services, Public Health Service, Nations Institutes of Health. office of Technology Assessment. 1988. Infertility: Medical and Social Choicer. CTA Be BP 48. August. Washington, D.C. Walters, LeRay. 1987. Ethics and New Reproductive Technologies: An International Review of Committee Statements. Hastings Center Report. June:3-9. - 14

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This book results from a study by a committee of the Institute of Medicine and the National Research Council's Board on Agriculture. The committee examined the scientific foundations of medically assisted conception and developed an agenda for basic research in reproductive and developmental biology that would contribute to advances in the clinical and agricultural practice of in vitro fertilization and embryo transfer. The volume also discusses some barriers to progress in research and ways of lowering them, and explains the scientific issues important to ethical decision making.

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