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The fertility industry claims that IVF products are safe; critics worry about oversubscription

“I felt that my insides were going to break out of my stomach,” recalls Andreott.

It was ovarian hyperstimulation syndrome – abbreviated as OHSS – a potentially fatal complication that the US fertility industry describes as extremely rare. However, the incidence of OHSS and the longer-term safety of hormones that increase hormone levels remain open to debate, even though the clinics have become a multi-billion dollar industry serving hundreds of thousands of women a year.

Industry critics are concerned that unregulated suppliers over-prescribe drugs, hide potential hazards and do not report problems properly when they occur. For example, one recently published study blamed “increasingly aggressive treatment protocols” for OHSS incidents, while another claimed that most cases were completely “preventable.”

Some researchers suggest that in addition to their association with OHSS, drugs can potentially lead to heart disease, depression, endocrine disorders, cancer, and many other conditions. However, several published studies are inconsistent or inconclusive. And unlike many developed countries with public health care, the United States makes no effort to track health outcomes in the treatment of infertility.

"Every fertility doctor says to every patient with fertility:" There are no known risks. Well, there are no known risks, because no one was watching, "said Dian Tober, a medical anthropologist from the University of California at San Francisco, who studies reproductive technology.

Industry proponents say that more than 8 million children have been born around the world thanks to IVF and other methods of treating infertility since the first test tube baby appeared 40 years ago. Alan Penzias, an adjunct professor at Harvard Medical School, who chairs the American Society for Reproductive Medicine (ASRM) practice committee, said he was “sufficiently convinced” that drugs do not pose a long-term threat to women's health.

“We are at that moment when, if there was something serious, we would have already seen it,” said Penzias, who is also the surgical director at Boston IVF. "Fortunately, we did not see anything negative."

OHSS is an exception. Being the most cruel and immediate complication of infertility treatment, it can affect anyone taking medications, induce the ovaries to ripen several eggs – a fundamental step in freezing eggs, in vitro fertilization (IVF) and egg donation, which occurs about 240,000 times a year.

In recent years, strategies have been developed to identify patients at high risk and treat the disease. ASRM, which represents the majority of clinics in the United States, calls OHSS a “rare but serious complication,” which is estimated to occur in moderate or severe form in just 1–5% of cycles. Fertility doctors often cite studies showing that severe OHSS occurs in 0.03 percent of cycles.

Penzias said that hospitalization for OHSS is "almost inaudible now" compared to 20 years ago. Nevertheless, the analysis carried out by the Washington Post according to the national emergency departments showed that the numbers remain significant. Between 2006 and 2014, more than 9,000 women sought help from the GHS to hospitals, and in the last year for which statistics are available, about 1,000 women per year.

In Sweden, Canada, and the United Kingdom — countries where governments regulate assisted reproduction and monitor patient outcomes — medical societies tell patients that an estimated one third of the procedures cause at least mild symptoms of OHSS.

This year, an independent British fertility regulator, the Department of Human Fertilization and Embryology, launched an investigation into the discrepancies between cases of OHSS registered in infertility clinics and a large number of hospitalized data. Despite the fact that the control group did not find evidence of systematic underestimation of data, it announced that it conducted audits at each clinic, stating that the data raised "significant issues and questions regarding the safety of patients undergoing IVF."

Gita Nargund, a fertility specialist in the UK, urges Parliament to update the reporting requirements for tracking drugs and dosages prescribed during IVF, and link IVF treatment journals to hospital registries to improve tracking of adverse reactions.

“Now I feel more concerned than ever before,” Nargund said. "It is extremely important that we do not make healthy women sick as a result of IVF treatment."

According to health officials, known deaths are rare, but they are also difficult to track. When the ovaries are over-stimulated, the body produces an excess of fluid that can drown vital organs, leading to a cascade of potentially fatal problems.

In one famous case of 2005, Temilola Akinbolombbe, 33, collapsed at a London bus stop shortly after starting a course of IVF drugs. The accumulation of fluid from OHSS led to the formation of a clot in the pelvic vein and, ultimately, to a heart attack.

The coroner called the cause of death an “accident” —a voluntary risk — a category that is more commonly used in cases of drug overdose and blue moon cases, such as fatal falls when taking selfies.

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Miracle Drugs

When fertility stimulants appeared on the market in the late 1960s, they were called “miraculous drugs” and were originally used to stimulate ovulation in women who could not produce eggs on their own. By the time the first commercial infertility treatment clinic was opened in Norfolk, Va., In 1979, the doctors had already realized that these drugs can be used much more aggressively.

Usually one egg matures in the ovaries of a woman every month and enters her uterus. Few of these eggs are destined to become babies; the rest are abnormal or faulty in some way.

Collecting one egg at a time would be unbearably ineffective for IVF. Thus, the preparations are calibrated so as to cause maturation of the batch of eggs – ideally, about 10-15, according to recent studies. Less and a woman's chances of having a child are reduced. More, and a woman’s own health may be at risk.

However, it is difficult to find out which and how much medicine to use. Considering that IVF can cost from $ 15,000 to $ 30,000 per attempt, doctors and patients often experience pressure to produce large numbers of eggs in each round.

Fertility groups have developed standard dosing regimens, but each protocol must be adapted to the size and condition of the individual woman. In the meantime, nothing prevents physicians who want to use large doses, and there is no systematic way to track doses or results.

Experts have long argued that a short release of estrogen, usually 10 days with IVF, is unlikely to have a profound long-term effect on a woman’s body. The researchers advocated additional research, noting that estrogen is known to contribute to the development of certain types of cancer.

In many ways, academic debates broke out in public anxiety in 2003, when Jessica Grace Wing, a graduate of Stanford University and three times an egg donor, died of metastatic colon cancer at the age of 32 years. Wing's mother, Jennifer Schneider, a doctor who specializes in internal medicine, began to put pressure on Congress and the states to enact laws that require better tracking of patients with fertility and an increase in funding for research on complications.

“As a scientist, I can’t say that I’m 100 percent sure that they were fertility medications,” Schneider said in an interview. "All I can say is the absolute absence of any other reason why she could get colon cancer."

Schneider also published articles in medical journals that attracted the attention of researchers abroad. Soon followed by large studies, which were attended by 50,000 women who took medication for infertility in Denmark, and 24,000 in Sweden. The study found no association between drugs and ovarian cancer.

The latest data, presented in June at a conference in Europe, also did not reveal an increased risk of ovarian cancer. And the study, published in July, did not reveal an increased risk of developing two other types of cancer – an invasive uterus and breast cancer – among 250,000 British women who were treated for infertility.

Current ASRM guidelines state: “There does not appear to be a significant increased risk of invasive ovarian, breast, or endometrial cancer for patients with fertility“ based on available data. ” For borderline ovarian tumors, the group recognizes that "several studies have shown a slight increased risk."

The guidelines do not mention colon cancer, perhaps because there is no consensus. A study in the Netherlands published in 2016 showed – “encouragingly,” the researchers wrote, “that women undergoing IVF do not appear to have an increased risk of developing colon cancer compared to the general population. However, in patients with IVF, the likelihood of developing colon cancer is almost two times higher than in women who have received non-IVF-related treatment, such as a tube surgery or intrauterine insemination, prompting researchers to suggest that “further research justified. "

Schneider notes that research usually does not distinguish between women who take medications for infertility for various reasons. Some are barren, some are barren, but are being treated for their partners, and some are selective freezers and egg donors. Schneider claims that these populations are different – and often very different in age and hormone levels.

“The results are mixed, because women receiving treatment for infertility are a diverse group,” said Schneider, adding that no research focuses solely on selective freezers and egg donors.

– – –

Drowning organs

Unlike cancer, there is little doubt about the relationship between fertility drugs and OHSS. Complaints about the status of filling the birth rate blogs and online support groups.

During the interviews, a dozen patients with OHSS described a feeling of confusion and chaos when the symptoms began. Most said they had never heard of ovarian hyperstimulation syndrome before they got sick.

22-year-old Asya Ulanova, an egg donor from New York, said she watched TV in November, when she suddenly felt "visceral" abdominal pain and it became difficult for her to breathe. An ambulance doctor told her that she had fluid in her stomach and gave her medicine for constipation. It was only much later that Ulanova learned that she was suffering from OHSS.

Emily Leigh, 34, an entrepreneur from Pensacola, Fla., Was preparing for IVF in 2014, when she gained 22 pounds in 48 hours. She nearly died and spent eight days in the hospital with a tube in her stomach to drain the fluid.

“Looking back, I did not know how terrible my situation was,” said Lei, who, during her hospitalization, found out that she was pregnant with twins.

Logan Andreotta said her fertility doctors described the risk of developing OHSS as “ridiculously low.” As a result, she was “not psychologically prepared” when she woke up one morning in 2014 and discovered that her stomach was swollen, as if she had suddenly become pregnant for 20 weeks.

Andreott was urgently sent to the clinic of reproductive medicine, where the doctor used a giant needle to “knock” on the fluid in her stomach.

“They were liters and liters, and they looked like Coca-Cola, which you buy in a store, a brownish-red liquid,” she recalls.

On the first day they filled four to five bottles. They filled out two or three more in subsequent visits. Andreotta said her recovery took almost four weeks.

Despite her agonizing experience, Andreotta, now 29, said she did not regret taking drugs. Of the 50 eggs recovered from her ovaries, four tests passed normally. One of them led to a daughter, Bonnie, who is now 4 years old. Two years ago, Bonnie had a sister Audrey, who was conceived without IVF.

But Andreotta said that she would advise other women taking medication for infertility to immediately report any unusual symptoms.

“I was very lucky,” she said. "They said that if I wait, I will literally die."

– – –

Echo effects

In the early 2000s, so many women appeared in emergency departments that were filled with excess fluid and suffered from congestive heart failure or other organs stopped, that this situation attracted the attention of Jacob Udella, a medical intern in Canada.

“We were puzzled. They didn’t have many risk factors, but the general theme was that they were receiving medication for infertility, ”recalls Udell. "They received large doses and tried to get pregnant."

Udell and his colleagues wondered if these patients with ER "could be the tip of the iceberg" and whether high levels of estrogen from infertility drugs could damage the blood vessel mucosa. Water flowing from these compromised blood vessel walls may explain fluid accumulation in the OHSS. Can it hurt the heart?

One study from Sweden suggested the same. Higher rates of hypertension and possibly stroke among patients with fertility have been reported. But a Canadian study with a similar design showed no connection.

So Udell, now an associate professor of medicine at the University of Toronto, teamed up with Natalie Dayan of McGill University in Montreal to conduct, it is believed, the first large-scale analysis of the relationship between infertility drugs and cardiovascular diseases.

A study published last year in the Journal of the American College of Cardiology, the study showed data from 42,000 fertility patients. Although the treatment did not appear to have affected the risk of a heart attack, it showed a potential, but not quite statistically significant, increase in the risk of stroke.

Dedell said that it is impossible to say whether the differences are related to drugs for the treatment of infertility or to problems related to fertility in women, age or other factors.

The results, he said, underscore the need for closer attention to patients with fertility.

“We may not see many immediate catastrophic diseases,” but “there may be more moderate, potential long-term effects of echo,” said DeDell.

“Sometimes after pregnancy, everyone turns to the child. But maybe you should think about mom. ”

This article was written by Ariana Eunjung Cha, The Washington Post reporter. Post Dan Keating contributed to this report.

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