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After thousands of dollars in out-of-pocket expenses, missed work and school for clinic appointments, drugs that made her feel bloated and tired, bruising injections to stabilize the uterine wall and stimulate ovaries and the painful egg retrieval, it was time.

Her embryo implantation was scheduled for the next morning. The clinic was part of the NewLife Fertility Centre chain, which boasts the 鈥渉ighest pregnancy success rates in all of Canada.鈥� Hassan felt their sacrifices would finally be worth it.

Instead, the couple was dealt a devastating twist in their fertility journey, one that would propel them not into parenthood but rather to the courts in a quest for transparency and accountability.

Fertility clinic oversight is ‘woefully inadequate’

As a growing number of aspiring parents are choosing to undergo in vitro fertilization (IVF), egg freezing and other expensive and invasive procedures, they have little insight into the quality of the clinics they鈥檝e entrusted with their bodies and money.

Proposed regulations were supposed to improve oversight of those working in fertility clinics and give better protections for the patients they鈥檙e serving. But they were never put into effect.

Instead, clinical staff who play crucial roles in handling patients’ fertilized eggs continue to require no licensing 鈥� nor do they have any professional regulator monitoring their performance.

鈥淥ntario鈥檚 oversight of fertility services is woefully inadequate,鈥� said Dr. Arthur Leader, a retired fertility doctor and professor emeritus at the University of Ottawa who sat on the expert panel that proposed the new regulations.

When problems occur, there are insufficient avenues for patients to seek help, experts say. So Hassan and other patients pursue accountability by filing lawsuits in court, where allegations of disturbing clinic errors are mounting.

One Ontario couple鈥檚 embryo was implanted in the wrong patient. Upon learning of the mistake, the patient terminated the nascent pregnancy.

In another ongoing case, new parents allege their clinic鈥檚 embryologist mixed up semen samples and fertilized the woman鈥檚 eggs with the wrong man鈥檚 sample. The couple say they did not realize what had happened until a DNA test administered two weeks after the birth revealed that the probability that the man was the baby’s father was zero per cent.

It is not known how common such errors are. Error reporting by most clinic staff, outside of doctors and nurses, is not mandatory, though experts and patient advocates say it should be.

Inside the doctor鈥檚 office, Hassan and her husband learned their embryos had been accidentally destroyed. A defective batch of a fluid the clinic used to preserve and help grow newly fertilized eggs was to blame, Hassan recalls being told.

鈥淚 was crying in the office, and there were patients outside. They were just looking at us,鈥� Hassan said. 鈥淚t was devastating.鈥�

The couple allege the clinic knew at least a month before their implantation date that there was a concern with the fluid after there was an issue with another patient鈥檚 eggs, but they did not immediately tell them.

The couple has sued the clinic and fluid manufacturer, but they say they still don鈥檛 have enough information about what happened to their embryos. In a statement of defence filed in court, the clinic denies the couple鈥檚 allegations. It says it was unaware of any problems with the fluid at the time of Hassan鈥檚 egg retrieval procedure.

Neither the clinic nor the manufacturer responded to requests for comment.

Planned reforms never put in place

In 2015, the Ontario government led by then-Premier Kathleen Wynne asked the province鈥檚 medical regulator to draw up a plan to strengthen oversight of fertility clinics operating outside of hospitals.

The College of Physicians and Surgeons of Ontario put together a panel of experts, who drafted expansive new rules. The proposed regulations sought to establish standards for training and clinical guidelines, as well as a thorough inspection regime and data reporting requirements.

Doctors consulted by the expert panel 鈥渋ndicated that the proposal was sensible and that it would help protect vulnerable patients,鈥� according to an internal Ministry of Health report on the proposed regulations.

The expert panel presented the proposed new rules to the province in 2017. But the regulations were never put in place.

A Ministry of Health spokesperson would not tell the Star why. The CPSO confirmed the amendments were approved but never finalized by the government.

Leader and two other doctors who developed the regulations told the Star they tried and failed to find out why they were never implemented. Leader attempted to obtain government meeting records through a freedom of information request to determine what happened but received mostly redacted records.

Among the proposals from the expert panel was a more robust verification process to ensure sperm, eggs and embryos don鈥檛 end up in the wrong patient.

It鈥檚 a measure that may have spared one Ontario couple from a gut-wrenching ordeal.

A Niagara Falls woman had undergone IVF at ONE Fertility in Burlington to have her first child. In 2021, ready for another child, she and her partner returned to the clinic, which had the couple鈥檚 three remaining frozen embryos.

Before the embryo transfer, they were told one of their embryos was missing, according to records filed in court. Then the clinic said the embryo had been “inadvertently” implanted in another patient. The couple were told that the patient terminated the pregnancy when she found out the embryo was not hers.

The Niagara Falls woman underwent transfers of her remaining two embryos, but both failed, which she attributes to the stress caused by the clinic’s mistake.

The couple sued the clinic, claiming $2 million for pain suffering, plus other damages. In its statement of defence, the clinic admitted the embryo was transferred to the wrong patient, but said it reimbursed the couple’s medication costs, reimbursed or waived treatment costs and refunded an annual administrative fee, and met “the applicable standard of care.” The case resolved, but the details are confidential, according to the couple鈥檚 lawyer, Jan Marin.聽

ONE Fertility鈥檚 board of directors told the Star in a statement it was unable to comment on specifics of the case, but said that patient feedback 鈥渃onstitutes an integral part of our efforts to continuously improve the quality of the care we provide.鈥� The clinic鈥檚 board also said that it regularly provides training opportunities to all staff, and it volunteers to go through additional evaluation by Accreditation Canada, which assesses health organizations, and has received 鈥渆xemplary standing鈥� in its last two inspections.

Certification remains voluntary for Ontario embryologists

The proposed regulations 鈥渟hould be introduced and enforced immediately,鈥� said Maureen McTeer, author and lawyer, specializing in health policy and medical law.

Vanessa Gruben, director of the University of Ottawa Centre for Health Law, Policy and Ethics, echoed McTeer鈥檚 call, saying there should be greater regulation and oversight, especially of those who handle reproductive materials such as eggs and semen. 鈥淢istakes happen, and we need to have systems in place to minimize those mistakes.鈥�

The proposed new regulatory regime would have imposed standards for embryology and implemented monitoring of their labs within clinics, according to a 2017 report by the expert panel.

Embryologists and other non-doctor staff manage the storage of embryos, as well as the freezing and thawing of sperm, eggs and embryos, among other crucial tasks at a clinic.

They are not overseen by a dedicated regulator. While clinics are supposed to ensure the quality of their staff and equipment, the only real external oversight is of doctors, who run clinics, and nurses, both through their respective provincial regulatory colleges.

Though embryologists may get voluntary certification, it is not required, nor are they licensed in Ontario or Canada. That means no one outside the clinic checks whether embryologists retrain when new technology is introduced to the field.

鈥淥ne of my colleagues likes to say that the person cleaning your teeth or giving you a massage is more highly regulated than the person looking after your embryos,鈥� said Dr. Heather Shapiro, an embryology expert and vice-chair of education in the department of obstetrics & gynaecology at the University of Toronto.

The Canadian Fertility and Andrology Society (CFAS), a non-profit representing doctors, nurses, embryologists and others in the sector, said its voluntary certification program is designed in part to raise awareness of patient vulnerability. The organization said it has a five-year plan to become a regulatory body for embryologists.

Meanwhile, the oversight of clinics remains largely as it was at the time of the proposed changes. The doctors who run clinics can be inspected by the CPSO, as infrequently as once every five years.

In April 2024, the province introduced inspections of clinic ultrasound equipment. In addition, Health Canada offers an online complaint portal where patients can register concerns related to assisted human reproduction, though any complaints about medical treatments should be referred to a provincial or college authority, the federal regulator said.

Dr. Nav Persaud said in his family clinic he hears from patients about their fertility treatment at private clinics, and he worries whether they鈥檙e being treated a bit too much like consumers.

鈥淪ome patients [feel] like they’re on a conveyor belt when they’re at the fertility clinic,鈥� said Persaud, who is also Canada Research Chair in Health Justice and who studies the efficacy of medications, including fertility treatments and medications. He said some patients tell him they feel pressured to agree with a proposed treatment plan, even if they don鈥檛 fully understand it, feel it鈥檚 right for them, or both.

鈥淎fter being in a crowded waiting room before being seen, sometimes patients feel rushed and not welcome to ask questions,鈥� he said.

IVF can be draining emotionally, physically and financially

The fertility industry is booming across Canada. IVF pregnancies and births have increased 20 per cent since 2013, and elective egg freezing nearly doubled during the same time period.

Fertility care is primarily offered in private, for-profit clinics. Last year, the Ontario government announced it was setting aside $150 million to fund fertility treatments, particularly IVF cycles, at 50 clinics over two years.

But accessing these funds is only possible for one round of IVF treatments to those under 43 years old. Medications prescribed for this procedure are not covered. A round, including medications, can cost more than $10,000, sometimes up to $20,000. Many women undergo multiple rounds to try to have a baby.

So most patients rely heavily on private insurance or pay out-of-pocket.

鈥淧eople are stressing their finances or sacrificing things in the rest of their life to make this happen,鈥� said Alana Cattapan, Canada Research Chair in the Politics of Reproduction and assistant professor at the University of Waterloo.

Hassan said IVF was not just a medical procedure. 鈥淚t’s a full-on commitment for your body and mind.”

With so much on the line for patients, an ombudsperson or independent board should be established to help regulate fertility clinics, said McTeer, a retired health policy lawyer. Such external oversight would promote greater confidence in fertility clinics, she said. 鈥淐reating families using reproductive technologies and both gametes (reproductive cells) and embryos, is not a business just like any other. It is a special, even sacred, undertaking; and should be treated as such.”

Ontario鈥檚 patient ombudsman only oversees the ultrasound services in a fertility clinic, and does not have jurisdiction over any other aspects.

‘Change is desperately needed’

Erika Belopotocanova went to four different regulators, from the doctors college to the information and privacy commissioner, in her exhaustive pursuit of information and accountability when she grew worried her clinic was not being transparent about a fertility procedure that she alleges made her sick.

Belopotocanova underwent intrauterine insemination, or IUI, in which processed sperm is inserted into a woman鈥檚 uterus while she is ovulating. She alleges the procedure made her sick for six months, and asked a clinic privacy officer for records of her care to determine what caused her illness. But the clinic said they did not have to provide the documents she requested. She later found out from her gynecologist’s office that she had been dismissed as a patient by the fertility clinic. Angered by the alleged brush-off, she complained to the provincial doctor regulator, Ontario Ombudsman, the Ontario Information and Privacy Commissioner and Health Professions Appeal and Review Board.

Belopotocanova said she would have gone to someone dedicated to being in fertility patients鈥� corner immediately following her illness. But following four years navigating government boards, she doesn鈥檛 know if a new one will lead to the improvements of the patient experience she hopes for, and said that starts with more open communication and transparency.

鈥淐hange is desperately needed,鈥� she said.

Patients have more avenues to complain in a fertility practice than at a family practice, said Dr. Prati Sharma, a doctor at Create Fertility and vice president of the Canadian Fertility and Andrology Society. Patients reach out to office management staff 鈥渁ll the time鈥� to complain about anything from treatment side effects to how much money they have spent at the clinic and still have not ended up with a pregnancy.

鈥淢ost things get resolved [internally], the things that go to lawsuit are thankfully low,鈥� she said.

One solution is discounts offered on future IVF cycles at their clinic, she said.

In Brampton, Hassan and Rashid are looking for a new clinic, but their confidence in the system has been shaken.

Every time the couple looks at TikTok or Instagram, the apps populate with videos of babies, which can make them both cry.

After NewLife staff told them about the embryo destruction, they also told the couple to hire a lawyer to pursue a product liability case against Cooper Surgical, the Connecticut-based maker of the egg preservation fluid, the couple said. That made Hassan feel like NewLife was treating them not as patients but as mere dissatisfied consumers.

But not seeing any other way to seek accountability, they sued not only Cooper Surgical, whose product was recalled by the U.S. Food and Drug Administration and Health Canada shortly after Hassan鈥檚 embryos were destroyed, but also the clinic, seeking $110,000 for negligence and product liability, among other damages.

As Hassan plans to continue with another round of fertility treatments once her husband鈥檚 insurance resets, she wants more transparency as she researches which clinic to choose.

鈥淚t’s not just about avoiding mistakes. It’s about protecting families, restoring trust in fertility treatments, and ensuring that every step of the process is held to the highest safety standard,鈥� she said.

Her husband Rashid added: 鈥淵ou are stepping into an environment where people’s trust in you is there, not just their money, but their emotions as well.鈥�