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Androlog Summary |
From the Division of Andrology, University of Illinois, Chicago, Illinois.
I recently was asked by Rupert Amann, PhD, if IUI fell under the definition of ART. My initial thought was that it did, as an assisted type of insemination, also falling under the definition of artificial insemination. However, Rupert recently sent me the following and gave me permission to share this with you: (Any comments?)"Congress passed The 1992 Fertility Clinic Success Rate and Certification Act (PL 102-493) found in 42 USC 263a1 et al, Oct 24, 1992. In the US Code appears the following definition: the term assisted reproductive technology means all treatments or procedures which include handling of human oocytes or embryos, including in vitro fertilization and such other specific technologies as the Secretary may include in the definition. In resulting regulations mandating registration of ART laboratories, annual reports of outcome, and current and pending FDA regulations pertaining to reproduction, ICSI was added as an ART because it meets the Congressional definition. Clearly, IUI does not fall under this definition and, hence, IUI is not an ART in the eyes of the government."
Mike Reed replied:
The question raised by Rupert, forwarded by Grace, extrapolates some interesting points: 1) the wide use of IUI (partner and anonymous sperm, performed in ART clinics, physician offices, and homes via cervical cap application, with natural and stimulated cycles), 2) timed intercourse cycles under the management of an ART clinic, physician office, etc, leading to the spectacularly large number of IUI and intercourse cycles managed in the United States (and abroad) in relation to the number of IVF cycles, and 3) legislation.
The definition that IUI is not ART seems to be further demonstrated by the beginning sentence from the year 2000 ASRM Practice Committee Report "Multiple Pregnancy Associated with Infertility Treatment" where it states that "the incidence of twin and high-order (triplet or greater) multiple gestations has increased over the past 15 years primarily due to the increased use of drugs for ovulation induction (OI), superovulation (SO), and assisted reproductive technologies (ART) including in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), and zygote intrafallopian transfer."
... Further, to my knowledge, there are no active oversight committees that stringently watch over or track the application of IUI or timed intercourse as an infertility treatment (compared to ART). I believe, though, that anyone performing IUIs in a clinical setting must be, at the very least, registered with CLIA to perform even qualitative or PPMP analysis of semen specimens (sperm, yes, motile, yes) for insemination.
Patrick Quinn makes the point, historically verified again and again, that what a government defines is not necessarily fact:
In response to Grace Centola's post from Rupert Amann about the definition of ART in the 1992 Fertility Clinic Success Rate and Certification Act (42 USC 263a1 et al, Oct 24, 1992), I have the following comment; just because the government decrees it doesn't mean that it is (or not) so. The definition of ART has been in use well before the government became interested. Does anyone know when the term was first used? I believe it might have been in some ASRM document.Ken Roberts replies:
On this thread of ART definition, I believe that the phrase defines itself. If a person(s) presents to a physician with a complaint of infertility and receives treatment, in the form of drugs, procedure, or instructions, that person(s) is now a patient receiving assistance with their reproductive efforts... assisted reproductive technology in practice.
I'm sure that legislative bodies will define ART in whatever manner fits their philosophy and, more important, budget. But I believe getting help with reproduction is, by definition, "assisted reproduction." Those in the fertility health care profession should get credit for all their efforts, not just the heroic ones.
Finally, Christopher De Jonge notes:
In response to the issue of IUI as a part of/or not the definition of ART, I heartily disagree with the exclusion of IUI. The generation of the definition came on the heels of the Wyden Act, which specifically and exclusively targeted IVF. In fault, the government never (at least to my knowledge) considered IUI. All subsequent iterations of the definition of ART have closely followed that of Wyden verbiage.
Insemination of washed sperm into the vagina/cervix/uterus is a(n) (artificial) technique used to assist reproduction. I feel that outcomes from that ART should be followed as they are for IVF.
"Government" is composed of people who govern and may or may not share similar principles and notions with science and medicine. By defining scientific and clinical nomenclature, the government may have a profound effect on the practice of andrology.
Footnotes
Note: Postings to Androlog have been lightly edited before publication.
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