Infertility treatments: A demand for more honesty

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The benefits of several widely used tests and treatments for infertility have never been clearly established in clinical trials, according to Howard W. Jones, Jr., M.D., and James P. Toner, M.D., Ph.D. In their recent review article in The New England Journal of Medicine (2 December 1993), the infertility specialists wrote, "A surprising number of pregnancies occur independently of treatment."

Perhaps Drs. Jones and Toner can be forgiven for being surprised that couples can actually conceive without the assistance of high-tech medical care. Both physicians are associated with the Jones Institute for Reproductive Medicine in Norfolk, VA, which has a long-standing reputation for pushing the frontiers of infertility treatments or, as they have become known, "assisted reproductive technologies."

What's noteworthy about the review, however, is their candor regarding the lack of scientific evidence behind what has become a $1 billion a year industry, and their acknowledgment of studies showing that the pregnancy rate among untreated infertile couples comes close to the rate for treated couples.

The definition of infertility is arbitrarily set at two years, but couples over the age of 30 are often deemed infertile after only one year of trying unsuccessfully to become pregnant. Whether the regular obstetrician/gynecologist is competent enough to treat infertility is subject to debate. Drs. Jones and Toner note that most "generalists in obstetrics and gynecology'' conduct infertility workups and prescribe drugs; half report that they perform complex surgery for conditions associated with infertility.

When these efforts fail, couples who can afford it move on to high-tech treatment at an infertility clinic, where a complete workup can cost $3,000. The most common procedure is in vitro fertilization (IVF) which involves the removal of a woman's eggs for fertilization in the laboratory and then implantation in the uterus; the successful result is a "test tube baby." Another common procedure is gamete intrafallopian transfer (GIFT), which unites the retrieved egg and sperm in the fallopian tubes in a one-step process.

Over the years several other procedures have been added to the list of possibilities, including microinjection of sperm, which Gail Vines described in New Scientist as "removing immature sperm from the man's testicles, drilling, tearing or chemically burning holes in the egg's outer coating (zona), or even, in the latest technique, injecting a single sperm into the body of the egg itself." High-tech infertility treatments are not only expensive, painful, and emotionally draining, but they also have very low success rates.

Infertility is believed to be on the rise: an estimated 25% of couples in their thirties are purportedly infertile. Infertility has long been regarded as a solely female problem; however, male infertility is now known to be a prime factor in 30% and a contributing factor in an additional 10-15% of all cases of infertility.

Over the last seven years there has been mounting pressure to make infertility clinics more accountable to the public, particularly where the reliability of their reported success rates is concerned. It has become an open secret that many clinics provide infertile couples with false information. The clamor for "truth in advertising," which initially came from infertility specialists and then infertile couples, eventually brought about Congressional hearings in 1988 and 1989, and, in the fall of 1992, legislation sponsored by Congressman Ron Wyden of Oregon (The Fertility Clinic Success Rate and Certification Act). If the law ever goes into effect (it appears stymied by the change in administrations), every infertility clinic will be required to report their success rates annually.

Just as airlines have been known to inflate their "on time take-off" record merely by closing the doors of the delayed plane and pulling it away from the gate, infertility clinics have equally creative ways of fudging their success rates. In one example reported in the October 1, 1992, Congressional Record, some clinics defined IVF success in terms of the rate of "clinical pregnancies," which refers to the fertilization of an egg in the laboratory rather than the rate of live births.

Over a year ago, the New York City Department of Consumer Affairs announced legal action against the prestigious Mt. Sinai Medical Center for deceptive trade practices. Mt. Sinai's promotional brochure aimed at infertile couples claimed a far higher success rate than it had submitted to the American Fertility Society and Society for Assisted Reproductive Technology's Annual Clinic Specific Report for the year 1990. (See "What You Can Do" at the end of this article.)

Mt. Sinai listed its "take home baby rate" for IVF as 20%, which implied that couples who seek treatment there have a one in five chance of giving birth after a single procedure. In reality this relatively high success rate applied to only a small subset of patients; Mt. Sinai's overall success with IVF was half of what it claimed in its promotional brochure. One IVF cycle can cost $8,000-$10,000, and it frequently takes several tries to conceive. Insurance companies usually put a limit on how many, if any, will be covered.

Success Rates Low
To make an informed decision about undergoing infertility treatment, a couple should know their odds of becoming pregnant without treatment. As Drs. Jones and Toner noted in their review, the untreated "infertile" couple's pregnancy rate is surprisingly high; in fact, it is only 6% lower than that of the treated infertile couple.

John A. Collins, M.D., professor of obstetrics/gynecology at McMaster University in Hamilton, Ontario, and colleagues at other Canadian medical centers, studied 1,145 couples who had been diagnosed as infertile; only half of them were treated (New England Journal of Medicine, 17 November 1983). After a two- to seven-year followup, pregnancies occurred in 41% of the treated couples and 35% of the untreated couples. The investigators cited earlier studies showing "the proportion of pregnancies that seem to be independent of treatment ranged from 21-62%." The untreated couples were on the waiting list for treatment at IVF clinics.

In a telephone interview, Dr. Collins was asked about the improvements made in infertility therapies during the decade since his study was published. "Treatment has developed in almost miraculous ways," he replied, "but this has not changed the basic likelihood of a couple succeeding." Dr. Collins has continued to compare the pregnancy rates of treated and untreated infertile couples. He cited his latest study of 2,000 couples followed for an average of 84 months was published in Fertility & Sterility last fall; the difference between the two groups is roughly the same as that found in his 1983 study.

The relatively small increase in pregnancy odds for the treated couples must be weighed against the risks of medical intervention. "Not many studies have looked at hazards," said Dr. Collins. "In general, [investigators] have looked at things that are relatively easy to identify, like multiple pregnancies, premature birth, and ovarian hyperstimulation syndrome." The last of these known risks is a fluid and hormone imbalance serious enough to hospitalize 3% of women given the ovulation-stimulating drugs, such as Clomid, crucial to most infertility treatments. Also, the rise in use of infertility drugs has produced an increase in twin births (2-3% increase in the 1980s) and has brought an associated increase in babies born with cerebral palsy. These drugs stimulate ovulation, producing multiple eggs, thus increasing the odds of several eggs being fertilized. A new study in Pediatrics (December 1993) found that twins are almost 12 times more likely than single-birth babies to be born with cerebral palsy.

The long-term risks are unknown even for IVF, which is over fifteen years old. The British publication New Scientist reported recently, "Epidemiologists argue that only international monitoring can determine whether the new reproductive technologies carry hidden risks for parents or their children" (27 November 1993).

What you can do
Before taking infertility drugs, women are advised to read about the side effects in the "patient packet insert," which must by law be given to all hormone drug users. Couples considering IVF are advised to ask for the clinic's "take home baby rate" specific to their individual diagnostic circumstances (for example, the woman is over the age of 40, and/or the man has sperm dysfunction). The law will authorize the Centers for Disease Control (CDC) to set uniform definitions for success rates, which must be reported to the Department of Health and Human Services. Basic requirements in terms of record-keeping, equipment, and personnel are also established. The reporting from each clinic will become an annual guidebook, published by the federal government. All clinics will be certified every two years and be subject to unannounced inspections.

Presently, couples are limited to guidebooks based on self-reported information from infertility clinics in the U.S. and Canada. In a month or two, the latest clinic-specific guide will be published by the Society for Assisted Reproductive Technologies (SART). The directory includes five pages for each of 247 clinics in the U.S. and five in Canada, listing such information as the take home baby or stillborn baby rates for IVF and GIFT for couples under 40 with no male factor, over 40 no male factor, etc. Success rates for other procedures like microinjection of sperm, etc., are also listed when applicable. For prices and an order form for the three-volume directory (which can be purchased in whole or in part) call (205) 978-5000, or write to SART, 1209 Montgomery Highway, Birmingham, AL 35216.

Another guide called In Vitro Fertilizations Clinics: A North American Directory of Programs and Services by Mary Partridge-Brown, lists program services, costs, and success rates for IVF and GIFT for nearly 250 clinics in a more user-friendly format than the SART directory. Success rates, however, are not broken down according to specifics like over 40 or under 40, as they are in the SART directory. It does list information not found in the SART directory, such as cost breakdown, types of drugs used, and anesthesia options. The section called "Requirements and Restrictions" provides additional information such as whether couples must be married.

For a copy of In Vitro Fertilization Clinics, send a check for $28.50 to McFarland & Company, Inc., Box 611, Jefferson, NC 28640.

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