In the six years she was treated at a private fertility clinic, Colleen Aitken had her husband’s specially prepared sperm inserted directly in her uterus on more than 20 occasions, with powerful drugs administered each time to stimulate her ovaries. She gave birth twice, but says the pregnancies the couple so fervently wanted came at a steep cost.
The number of so-called “intra-uterine insemination” (IUI) treatments and the associated drug use well exceeded what many fertility experts describe as the norm in the field and, according to doctors who ended up helping her later, caused dangerous internal damage.
Ms. Aitken eventually received emergency surgery to remove her ovaries and staunch internal bleeding, leaving the resident of St. Thomas, Ont., unable to conceive, on hormone-replacement therapy and, according to Ms. Aitken, forced to abandon her public-health nurse job because of ongoing pain and other symptoms.
“There is just so much anger,” she said of her ordeal. “I wish I could go and take back what happened to me. … It has had a tremendous impact on my life.”
The College of Physicians and Surgeons, Ontario’s medical regulator, is investigating her complaints. The Southern Ontario Fertility Technologies (SOFT) clinic where Ms. Aitken was treated said it could not comment on her case. Dr. James Martin, the clinic’s director, cautioned, however, to be careful with his patient’s version of events.
“This person had two babies, obviously her treatment was successful,” he said. “I really don’t have any evidence as a doctor that her ovaries were damaged.”
Nevertheless, Ms. Aitken’s case forms part of a medical practice that is causing growing concern in the fertility-treatment world. IUI — commonly known as artificial insemination — is being practised widely, with little regulation and largely under the radar by a broad array of doctors and nurses, often with little control over what sort of pregnancy results, critics say.
The treatment is likely a major cause of the boom in multiple births that has burdened the health care system and parents with a growing number of tiny babies often suffering serious health problems, they charge. Until now, the debate over the epidemic of multiples has centred almost exclusively on the more technologically dazzling in vitro fertilization (IVF) — where eggs and sperm are combined in a petri dish to produce an embryo — with repeated calls to restrict the number of artificially-created embryos that can be inserted in would-be mothers, producing so-called test-tube babies. When just one embryo is “transferred,” the chances of getting pregnant with multiples are reduced to almost nil.
Yet some physicians say IUI may be triggering even more twins, triplets and other multiples, and note that, unlike in IVF, it is extremely hard to limit the possibility of multiple births and the complications that can ensue.
“IUI is unfortunately the elephant in the room,” said Dr. John McNaught of the London Health Sciences Centre fertility clinic, who once worked with Dr. Martin. “Twenty-two thousand of these procedures are done on the public dollar [in Ontario] every year, and what registry tracks the complications resulting from them? What credentialling exists for the people who do these procedures?”
There is also evidence that some clinics administer many more treatments than are likely to be effective, with Ontario covering the whole cost under medicare and other provinces paying for some. The much more pricey IVF, on the other hand, is funded only in Quebec, under a new program that requires patients to receive just one test-tube-fertilized embryo at a time.
Demand for all types of fertility treatment is on the rise these days. Canadian Fertility and Andrology Society statistics show the number of in vitro procedures has jumped by more than 50% to 10,300 a year in the last six years, with about 29% of pregnancies resulting in multiples. The number of multiple births in Canada surged 45% to almost 12,000 between 1991 and 2008, according to Statistics Canada, even as the number of singletons dropped. Often born early and at a low weight, twins, triplets and above pose a much greater risk of delivery complications and birth defects. Some neo-natal intensive-care units are so crowded with complex cases, high-risk pregnancies often have to be transferred to other cities or even to the U.S.
The issue has put intense focus on IVF, with critics complaining about the common practice of inserting two or more embryos in patients, making multiples more likely.
IUI, meanwhile, has drawn little attention. Fertility doctors say anecdotal evidence points to it being widely used, though there is no national surveillance system, collection of statistics or standards that its practitioners must follow. About 23,000 IUI cycles are performed a year in Ontario alone — over twice the number of IVFs nation-wide — with as many as 29% of the resulting pregnancies being multiples, according to the 2009 report of an Ontario expert panel. That could translate into hundreds, if not thousands, of babies born every year as part of twins or high-order multiples, in just one province.
“We think there’s probably more of an issue with multiple birth in IUI than in IVF,” said Dr. Carl Laskin, president of the Canadian Fertility and Andrology Society, the specialty association. “You’re putting sperm right into the uterus and you can’t control what’s going to fertilize and what isn’t.”
For doctors who do not perform in vitro — which requires investment in sophisticated and expensive laboratories — and patients who cannot afford it, though, IUI can be an appealing option.
“It gets done by family docs in some cases, in some cases it’s done by generalist obstetrician-gynecologists who are not involved in a fertility clinic,” said Roger Pierson, an infertility expert at the University of Saskatchewan. “It’s kind of grown like Topsy.”
Most fertility experts interviewed recently said the accepted norm is to try artificial insemination up to three, or at most six, times, after which point the chances of getting the patient pregnant falls precipitously, making the treatment hard to justify medically and financially. At least one specialist, however, argues that such limits can unjustifiably curb choices for patients unable to foot the hefty bill — over $5,000 — for IVF.
Statistics published online by Dr. Martin’s SOFT clinic in London showed that its patients received more than six IUI treatments on 3,741 occasions between 2001 and Jan. 2010. Pregnancy resulted in 7% of those cases, compared to 19% after just one procedure.
The clinic is “pretty cautious” about doing more than six IUI treatments; if governments funded in vitro fertilization, many would be moved on to that treatment, said Dr. Martin. As it stands now, though, that is sometimes not an option financially, and the 7% pregnancy rate after multiple IUI treatments is still better than the less than 1% chance of having a baby for those same infertile couples with no medical help at all, he said.
“Try to tell somebody who really desperately wants pregnancy that there’s no other option for them: ‘Just go home and don’t get pregnant,’ ” said Dr. Martin. “It’s like saying, ‘Well, your heart is bad but we don’t really want to do a heart transplant, so just go home and die.’ ”
What is more, he said, just 13 sets of triplets and 159 sets of twins have been born in over 4,000 pregnancies, using various types of treatment, at the SOFT clinic.
Nevertheless, the fertility society is now developing stringent guidelines for IUI — as well as other, higher-profile treatments — that it hopes will be adopted by the provinces as regulations, said Dr. Laskin.
Ms. Aitken and her husband sought fertility treatment because of her ovulation difficulties and his reduced sperm count. She underwent 10 “cycles” of IUI before giving birth finally in October 2003. She went back again, had three more full cycles and one cancelled one where she just got the drugs, and then another baby. In trying to have a third child, she submitted to a further 11 IUI and three IVF treatments. By this time, however, the use of potent drugs to boost ovulation — and produce more eggs — for each insemination had taken a serious toll, she and some experts maintain. An ultrasound showed she had several large ovarian cysts, while her levels of the hormone estradiol were sky-high, according to a surgical report, potentially raising the risk of stroke.
The report says emergency surgery found the adnexa — ovaries, fallopian tubes and surrounding tissue — were bleeding, very large and “grossly abnormal,” prompting surgeons to remove Ms. Aitken’s ovaries. Reports by pathologists at two London-area hospitals blamed the harm on ovulation drugs. Dr. Martin has since said he advised her often against undergoing repeated, back-to-back treatments, although he still does not believe the surgery was necessary or that the drugs harmed his patient’s ovaries.
Ms. Aitken maintains the physician only once ever suggested she take a break between procedures, while insisting the treatments posed little health risk, reassurances she admits she was willing to accept in her deep wish to build a family.
“Emotionally, financially, socially, physically and mentally, you are so vulnerable,” she said. “Whatever hope the doctor provides to you, you just cling on to that and pray that you get pregnant.”
National Post
tblackwell@nationalpost.com
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