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Suggested Citation:"Front Matter." Institute of Medicine and National Research Council. 2007. Assessing the Medical Risks of Human Oocyte Donation for Stem Cell Research: Workshop Report. Washington, DC: The National Academies Press. doi: 10.17226/11832.
×

ASSESSING THE MEDICAL RISKS OF HUMAN OOCYTE DONATION FOR STEM CELL RESEARCH

Workshop Report

Committee on Assessing the Medical Risks of Human Oocyte Donation for Stem Cell Research

Board on Health Sciences Policy

Institute of Medicine

Board on Life Sciences

Division on Earth and Life Studies

Linda Giudice, Eileen Santa, and Robert Pool, Editors

INSTITUTE OF MEDICINE AND NATIONAL RESEARCH COUNCIL OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS

Washington, D.C. www.nap.edu

Suggested Citation:"Front Matter." Institute of Medicine and National Research Council. 2007. Assessing the Medical Risks of Human Oocyte Donation for Stem Cell Research: Workshop Report. Washington, DC: The National Academies Press. doi: 10.17226/11832.
×

THE NATIONAL ACADEMIES PRESS

500 Fifth Street, N.W. Washington, DC 20001

NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance.

This study was supported by Award No. CIRM-2039 between the National Academy of Sciences and the California Institute for Regenerative Medicine. Any opinions, findings, or conclusions expressed in this publication are those of the author(s) and do not necessarily reflect the view of the organizations or agencies that provided support for this project.

International Standard Book Number 10: 0-309-10355-X

International Standard Book Number 13: 978-0-309-10355-8

Additional copies of this report are available from the

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Copyright 2007 by the National Academy of Sciences. All rights reserved.

Printed in the United States of America.

Suggested citation: Institute of Medicine (IOM) and National Research Council (NRC). 2007. Assessing the medical risks of human oocyte donation for stem cell research: Workshop Report. Washington, DC: The National Academies Press.

Suggested Citation:"Front Matter." Institute of Medicine and National Research Council. 2007. Assessing the Medical Risks of Human Oocyte Donation for Stem Cell Research: Workshop Report. Washington, DC: The National Academies Press. doi: 10.17226/11832.
×

THE NATIONAL ACADEMIES

Advisers to the Nation on Science, Engineering, and Medicine


The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Academy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Ralph J. Cicerone is president of the National Academy of Sciences.


The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding engineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Wm. A. Wulf is president of the National Academy of Engineering.


The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Institute acts under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Harvey V. Fineberg is president of the Institute of Medicine.


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 principal operating agency 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. Dr. Ralph J. Cicerone and Dr. Wm. A. Wulf are chair and vice chair, respectively, of the National Research Council.


www.national-academies.org

Suggested Citation:"Front Matter." Institute of Medicine and National Research Council. 2007. Assessing the Medical Risks of Human Oocyte Donation for Stem Cell Research: Workshop Report. Washington, DC: The National Academies Press. doi: 10.17226/11832.
×

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Suggested Citation:"Front Matter." Institute of Medicine and National Research Council. 2007. Assessing the Medical Risks of Human Oocyte Donation for Stem Cell Research: Workshop Report. Washington, DC: The National Academies Press. doi: 10.17226/11832.
×

COMMITTEE ON ASSESSING THE MEDICAL RISKS OF HUMAN OOCYTE DONATION FOR STEM CELL RESEARCH

LINDA C. GIUDICE (Chair),

University of California, San Francisco

EZRA C. DAVIDSON, JR.,

University of California, Los Angeles

NAIHUA DUAN,

University of California, Los Angeles

BERNARD L. HARLOW,

University of Minnesota, Minneapolis

SUSAN C. KLOCK,

Northwestern University, Chicago, Illinois

JUDITH H. LAROSA,

State University of New York, Brooklyn

CATHERINE RACOWSKY,

Harvard Medical School, Boston, Massachusetts

ZEV ROSENWAKS,

Cornell University, New York

JOE LEIGH SIMPSON,

Baylor College of Medicine, Houston, Texas

Staff

EILEEN SANTA, Responsible Staff Officer

AMY HAAS, Administrative Assistant

ANDREW M. POPE, Director,

Board on Health Sciences Policy

FRANCES E. SHARPLES, Director,

Board on Life Sciences

Suggested Citation:"Front Matter." Institute of Medicine and National Research Council. 2007. Assessing the Medical Risks of Human Oocyte Donation for Stem Cell Research: Workshop Report. Washington, DC: The National Academies Press. doi: 10.17226/11832.
×

BOARD ON HEALTH SCIENCES POLICY

FRED H. GAGE (Chair),

The Salk Institute for Biological Studies, La Jolla, California

GAIL H. CASSELL,

Eli Lilly and Company, Indianapolis, Indiana

JAMES F. CHILDRESS,

University of Virginia, Charlottesville

ELLEN WRIGHT CLAYTON,

Vanderbilt University Medical School, Nashville, Tennessee

DAVID R. COX,

Perlegen Sciences, Mountain View, California

LYNN R. GOLDMAN,

Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland

BERNARD D. GOLDSTEIN,

University of Pittsburgh, Pittsburgh, Pennsylvania

MARTHA N. HILL,

Johns Hopkins University School of Nursing, Baltimore, Maryland

ALAN LESHNER,

American Association for the Advancement of Science, Washington, D.C.

DANIEL MASYS,

Vanderbilt University Medical Center, Nashville, Tennessee

JONATHAN D. MORENO,

University of Virginia, Charlottesville

E. ALBERT REECE,

University of Arkansas, Little Rock

MYRL WEINBERG,

National Health Council, Washington, D.C.

MICHAEL J. WELCH,

Washington University School of Medicine, St. Louis, Missouri

OWEN N. WITTE,

University of California, Los Angeles

MARY WOOLLEY,

Research!America, Alexandria, Virginia

IOM Staff

ANDREW M. POPE, Director

AMY HAAS, Board Assistant

DAVID CODREA, Financial Associate

Suggested Citation:"Front Matter." Institute of Medicine and National Research Council. 2007. Assessing the Medical Risks of Human Oocyte Donation for Stem Cell Research: Workshop Report. Washington, DC: The National Academies Press. doi: 10.17226/11832.
×

BOARD ON LIFE SCIENCES

KEITH YAMAMOTO (Chair),

University of California, San Francisco

ANN M. ARVIN,

Stanford University School of Medicine, Stanford, California

JEFFREY L. BENNETZEN,

University of Georgia, Athens

RUTH BERKELMAN,

Emory University, Atlanta, Georgia

DEBORAH BLUM,

University of Wisconsin, Madison

R. ALTA CHARO,

University of Wisconsin, Madison

JEFFREY L. DANGL,

University of North Carolina, Chapel Hill

PAUL R. EHRLICH,

Stanford University, Stanford, California

MARK D. FITZSIMMONS,

John D. and Catherine T. MacArthur Foundation, Chicago, Illinois

JO HANDELSMAN,

University of Wisconsin, Madison

ED HARLOW,

Harvard Medical School, Boston, Massachusetts

KENNETH H. KELLER,

University of Minnesota, Minneapolis

RANDALL MURCH,

Virginia Polytechnic Institute and State University, Alexandria

GREGORY A. PETSKO,

Brandeis University, Waltham, Massachusetts

MURIEL E. POSTON,

Skidmore College, Saratoga Springs, New York

JAMES REICHMAN,

University of California, Santa Barbara

MARC T. TESSIER-LAVIGNE,

Genentech, Inc., South San Francisco, California

JAMES TIEDJE,

Michigan State University, East Lansing

TERRY L. YATES,

University of New Mexico, Albuquerque

NRC Staff

FRANCES E. SHARPLES, Director

KERRY A. BRENNER, Senior Program Officer

MARILEE K. SHELTON-DAVENPORT, Senior Program Officer

EVONNE P.Y. TANG, Senior Program Officer

ROBERT T. YUAN, Senior Program Officer

ADAM P. FAGEN, Program Officer

ANN H. REID, Senior Program Officer

ANNA FARRAR, Financial Associate

ANNE F. JURKOWSKI, Senior Program Assistant

TOVA G. JACOBOVITS, Senior Program Assistant

Page viii Cite
Suggested Citation:"Front Matter." Institute of Medicine and National Research Council. 2007. Assessing the Medical Risks of Human Oocyte Donation for Stem Cell Research: Workshop Report. Washington, DC: The National Academies Press. doi: 10.17226/11832.
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Suggested Citation:"Front Matter." Institute of Medicine and National Research Council. 2007. Assessing the Medical Risks of Human Oocyte Donation for Stem Cell Research: Workshop Report. Washington, DC: The National Academies Press. doi: 10.17226/11832.
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Independent Report Reviewers

This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the NRC’s Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its published report as sound as possible and to ensure that the report meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process. We wish to thank the following individuals for their review of this report:


Linda D. Applegarth, The Center for Reproductive Medicine & Infertility, Weill Medical College of Cornell University

Louise A. Brinton, Hormonal and Reproductive Epidemiology Branch, National Cancer Institute

Susan Berke Fogel, Pro-Choice Alliance for Responsible Research

Joel Howell, School of Public Health and Medical School, University of Michigan

Richard S. Legro, Department of Obstetrics and Gynecology, Pennsylvania State University College of Medicine

Richard Paulson, Division of Reproductive Endocrinology and Infertility, Keck School of Medicine, University of Southern California


Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the final draft of the report before its release. The review of this report was over-

Suggested Citation:"Front Matter." Institute of Medicine and National Research Council. 2007. Assessing the Medical Risks of Human Oocyte Donation for Stem Cell Research: Workshop Report. Washington, DC: The National Academies Press. doi: 10.17226/11832.
×

seen by Dr. Mary Jane Osborn, University of Connecticut Health Center. Appointed by the National Research Council and the Institute of Medicine, she was responsible for making certain that an independent examination of this report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this report rests entirely with the authoring committee and the institution.

Suggested Citation:"Front Matter." Institute of Medicine and National Research Council. 2007. Assessing the Medical Risks of Human Oocyte Donation for Stem Cell Research: Workshop Report. Washington, DC: The National Academies Press. doi: 10.17226/11832.
×

Preface

Stem cells have the potential to cure common, as well as rare, chronic diseases. They also are the focus of intense basic research to elucidate fundamental biological processes as well as the subject of applied research efforts, such as in testing the efficacy and mechanisms of specific drugs and chemicals. Because of the far-reaching opportunities offered by stem cells, the voters in California, in November 2004, approved Proposition 71, a 10-year, $3 billion program to fund stem cell research under the auspices of the newly formed California Institute for Regenerative Medicine.

This bold program has articulated a strategic plan that includes building facilities in which stem cell research will be conducted, training scientists in the conduct of stem cell research, and developing therapies of stem cell transplantation into people with the goal of improving human health. To accomplish these goals, stem cells from a variety of sources—adult tissues, fetal tissues, gametes, amniotic fluid, human embryos—will be of value in this major program, and a large supply of these is anticipated for eventual, large-scale therapeutic trials and eventually therapies for relief of human suffering from chronic diseases. Human eggs (oocytes) and embryos that may serve as a resource in stem cell research will come from human donors. The task of the Committee on Assessing the Medical Risks of Human Oocyte Donation for Stem Cell Research was to organize a workshop and prepare a summary of the current state of knowledge of the medical risks of human oocyte donation for stem cell research.

Suggested Citation:"Front Matter." Institute of Medicine and National Research Council. 2007. Assessing the Medical Risks of Human Oocyte Donation for Stem Cell Research: Workshop Report. Washington, DC: The National Academies Press. doi: 10.17226/11832.
×

Human embryonic stem cells are currently derived primarily from unwanted or “surplus” (donated) human embryos from patients who have undergone treatments for infertility. Human embryonic stem cells may also be derived by a process called somatic cell nuclear transfer, in which the nucleus of a somatic cell (i.e., a cell that is neither an egg nor a sperm) is transferred into a human egg as its nucleus. Thus, for human embryonic stem cells, the human egg is a vital component of the process, and these eggs come from the ovaries of women who would choose to donate their eggs (or embryos) for this research effort. Because it is not known with certainty how many unwanted and donated embryos from fertility clinics are available nationally for stem cell research, it is likely that the majority of eggs will come from human donors. The donation process involves stimulation of the ovaries with fertility medications (gonadotropins) and subsequent retrieval of the eggs from a woman’s ovaries, usually in an operative procedure requiring light anesthesia.

The California Institute for Regenerative Medicine approached the Institute of Medicine and the National Research Council about convening a committee of experts to ascertain the medical risks of oocyte donation for stem cell research. The committee members are leaders in the fields of human embryology, reproductive medicine, reproductive psychology, women’s health, and biostatistics. The group prioritized the issues and recommended a group of experts in the field to attend a workshop to discuss what is known about the medical risks, what needs to be known, and what can be done to reduce the potential risks over time. This workshop was convened on September 28, 2006, in San Francisco.

The workshop focused on potential acute and chronic risks of oocyte donation for stem cell research. The acute risks discussed were ovarian hyperstimulation syndrome and surgical, infectious, and anesthetic risks; and potential chronic risks, including breast, ovarian, and endometrial cancer; future fertility; and psychological risks. The workshop included attendees with expertise and interest in the field, and a dialogue ensued among the speakers, the committee members, and the attendees in the audience. The event was also webcast so that interested members of the public could participate in the proceedings.

This report describes scientific and clinical studies and the data derived from them, on which the risks were assessed as well as the methodological and study limitations that have made definitive risk assessment, for some risks, difficult to ascertain. The report contains neither speculation nor information outside what was discussed at the work-

Page xiii Cite
Suggested Citation:"Front Matter." Institute of Medicine and National Research Council. 2007. Assessing the Medical Risks of Human Oocyte Donation for Stem Cell Research: Workshop Report. Washington, DC: The National Academies Press. doi: 10.17226/11832.
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shop, and it does not contain recommendations. We hope that the report will serve as a resource on the state of the knowledge of acute, chronic, and potential risks associated with oocyte donation for stem cell research for the California Institute for Regenerative Medicine and others wanting more information about this interface between science and medicine.


Linda C. Giudice, Chair

Committee on Assessing the Medical Risks of Human Oocyte Donation for Stem Cell Research

Suggested Citation:"Front Matter." Institute of Medicine and National Research Council. 2007. Assessing the Medical Risks of Human Oocyte Donation for Stem Cell Research: Workshop Report. Washington, DC: The National Academies Press. doi: 10.17226/11832.
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Suggested Citation:"Front Matter." Institute of Medicine and National Research Council. 2007. Assessing the Medical Risks of Human Oocyte Donation for Stem Cell Research: Workshop Report. Washington, DC: The National Academies Press. doi: 10.17226/11832.
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Suggested Citation:"Front Matter." Institute of Medicine and National Research Council. 2007. Assessing the Medical Risks of Human Oocyte Donation for Stem Cell Research: Workshop Report. Washington, DC: The National Academies Press. doi: 10.17226/11832.
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Suggested Citation:"Front Matter." Institute of Medicine and National Research Council. 2007. Assessing the Medical Risks of Human Oocyte Donation for Stem Cell Research: Workshop Report. Washington, DC: The National Academies Press. doi: 10.17226/11832.
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Suggested Citation:"Front Matter." Institute of Medicine and National Research Council. 2007. Assessing the Medical Risks of Human Oocyte Donation for Stem Cell Research: Workshop Report. Washington, DC: The National Academies Press. doi: 10.17226/11832.
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It is widely understood that stem cell treatments have the potential to revolutionize medicine. Because of this potential, in 2004 California voters approved Proposition 71 to set up a 10-year, $3 billion program to fund research on stem cells. Under the direction of the California Institute for Regenerative Medicine, this program will pay to build facilities for stem cell research and will fund doctors and scientists to carry out research with the ultimate goal of helping to develop therapies based on stem cells.

For this research to move forward, however, will require a steady supply of stem cells, particularly human embryonic stem cells. Those stem cells are collected from developing human embryos created from eggs—or oocytes—harvested from the ovaries of female donors. Thus much of the promise of stem cells depends on women choosing to donate oocytes to the research effort.

The oocyte donation process is not without risk, however. Donors are given doses of hormones to trigger the production of more eggs than would normally be produced, and this hormone treatment can have various side effects. Once the eggs have matured in the ovary, they must be retrieved via a surgical procedure that is typically performed under anesthesia, and both the surgery and the anesthesia carry their own risks. Furthermore, given the very personal nature of egg donation, the experience may carry psychological risks for some women as well.

With this in mind, in 2006 the California Institute for Regenerative Medicine contracted with the National Academies to organize a workshop that would bring together experts from various areas to speak about the potential risks of oocyte donation and to summarize what is known and what needs to be known about this topic. The Committee on Assessing the Medical Risks of Human Oocyte Donation for Stem Cell Research was formed to plan the workshop, which was held in San Francisco on September 28, 2006. This report is a summary and synthesis of that workshop.

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