Revised minimum standards for in vitro fertilization, gamete intrafallopian transfer, related procedures

FERTILITY AND STERILITY

Vol. 53, No.2, Fehruary 1990

Printed on acid-free paper in U.S.A.

Copyright <> 1990 The American Fertility Society

Revised minimum standards for in vitro fertilization gamete intrafallopian transfer, and related procedures* '

The American Fertility Societyt Birmingham, Alabama

I. INTRODUCTION

In the six years since the preparation of the initial minimal standards for programs of in vitro fertilization (IVF)/ IVF has developed from a research procedure, requiring Institutional Review Board approval and available in only a few centers, to a widely applied and successful procedure performed in over 150 centers in the United States alone. For the purposes of these standards, all treatments which include the laboratory handling of human oocyte and/or embryos are termed advanced reproductive technology (ART) procedures. These include IVF, gamete intrafallopian transfer (GIFT), and procedures with acronyms such as PROST (pronuclear stage tubal transfer), TET (tubal embryo transfer), and ZIFT (zygote intrafallopian transfer). With the proliferation of ART programs and the recent controversy concerning the numerous United States IVF programs reported to have little or no success, it was believed appropriate to issue an updated set of minimum standards for ART programs. II. PERSONNEL

An ART program must include, as a minimum, personnel with the following expertise. A single inReceived November 21, 1989.

* Report of an Ad Hoc Committee of the Society for Assisted Reproductive Technology: Martin M. Quigley, M.D., Chairman, Jacques Cohen, Ph.D., David R. Meldrum, M.D., and Zev Rosenwaks, M.D. Approved by the Board of Directors of The American Fertility Society, November 10, 1989. t Reprint requests: The American Fertility Society, 2140 11th Avenue S, Suite 200, Birmingham, Alabama 35205. Vol. 53, No.2, February 1990

dividual may fulfill the requirement for expertise in one or more areas. 1. An individual with training and experience in reproductive endocrinology, particularly in the use of ovulation-inducing agents and the hormonal control of the menstrual cycle. An individual who has completed a Board-approved Fellowship in Reproductive Endocrinology obviously fulfills this requirement. 2. An individual with expertise in pelvic reparative (infertility) surgery as well as experience in laparoscopic and ultrasound-guided oocyte retrieval techniques. This combined expertise is necessary not only for the performance of the oocyte retrieval procedures, but also to ensure that the infertile couple is offered the most appropriate treatment modality. . 3. Each program must have a director of the embryology laboratory. This laboratory director must have personal experience in the organization and maintenance of a basic or clinical embryology laboratory as well as in tissue culture techniques. 4. An ultrasonographer (or obstetrician-gynecologist with specialized training and experience in gynecologic sonography) who provides the monitoring of follicular development and supervises ultrasound-directed oocyte retrival. 5. Each program must have a designated overall program director. If the overall program director is not a licensed physician, then there must be a designated "Medical Director" who is responsible for the clinical aspects of the treatment program.

III. GIFT AND RELATED PROCEDURES

Previously, The American Fertility Society has issued minimal standards for GIFT. 2 In view of the

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fact that technical considerations at the time of oocyte recovery may prevent tubal transfer and/or oocytes in excess of those recommended for tubal transfer may be obtained, this Committee reiterates the prior recommendation that GIFT only be performed in a facility that is prepared to carry out IVF, as an alternative or in addition, in the event that the GIFT procedure turns out not to be feasible and/or excess oocytes are recovered. Accordingly, a GIFT program must have an embryo laboratory and personnel capable of providing IVF. This is not to say that GIFT is not an appropriate treatment choice for certain patients, but only that the embryo laboratory equipment, procedures, quality control, and personnel must be proven by successfully performing IVF. IV. EXPERIMENTAL PROCEDURES

It is recognized that ART treatments are rapidly evolving. Because of the ethical concerns involved in treatments which involve the laboratory handling and manipulation of human gametes and embryos' The American Fertility Society's Ethics Committee has issued a report on the ethical considerations of ART procedures. 3 It is presumed that all ART procedures will be performed in accordance with the recommendations contained in that report, as well as any future reports from the Ethics Committee. At the present time IVF, GIFT, the use of donor oocytes and donor pre-embryos, and embryo cryopreservation are recognized as clinical, i.e., nonexperimental, procedures. Examples of procedures which are currently considered experimental include oocyte freezing, "ovum transfer" (or embryo flushing from the uterus and transfer to another woman), and oocyte and embryo micromanipulation techniques. Procedures considered experimental must be conducted under the supervision of an Institutional Review Board or equivalent committee. From time to time the Board of Directors of The American Fertility Society will issue statements indicating that certain procedures previously considered experimental will henceforth be considered clinically proven treatments.

V. RECORD KEEPING

In view of the continuing controversy about the success rate of IVF, it is recommended that all pro-

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grams performing IVF, GIFT, and related procedures participate in the U.S. IVF Registry which is conducted by Medical Research International (Lexington, MA). Furthermore, it is recommended that each program release (or permit the release from the Registry) of identifiable, clinic-specific success rates in ordl'lr that patients and physicians may make appropriate choices among programs. As a minimum, the releases data should include the number of stimulation cycles begun, the number of oocyte retrieval procedures attempted, the number of woman who became pregnant, and most importantly, the number of women who delivered live babies. Annualized statistics should be available within 12 months of the completion of the year's treatment cycles in order that the outcome of all the established pregnancies are available for inclusion. Programs that choose not to participate in the U.S. IVF Registry should prepare similar summaries of their results. VI. INFORMED CONSENT

As with all medical procedures and treatments, the patients must make the final decision on what is appropriate and acceptable treatment in their particular situation. To comply with this requirement, it is necessary that each prospective patient couple be provided with full disclosure including, as a minimum, the program's own experience with the specific procedure in question, including how long they have been performing it, how many times they have performed it, and what their past and current success rates are. It is emphasized that, particularly when a center is instituting a new procedure, "worldwide" experience not be the sole information provided to the couple. It is also important that couples be provided full information concerning alternative procedures available to circumvent their specific infertility problem, including procedures that are not performed by the treating center. REFERENCES 1. American Fertility Society: Minimal standards for pro-

grams of in vitro fertilization. Fertil Steril41:13, 1984 2. The American Fertility Society: Minimal standards for gamete intrafallopian transfer (GIFT). Fertw. Steril 50:20, 1988 3. The Ethics Committee of The American Fertility Society: Ethical considerations of the new reproductive technologies. Fertil Steril46:(suppll):IS, 1986

Revised IVF minimum standards

Fertility and Sterility