Issue link: https://maltatoday.uberflip.com/i/1468438
2 maltatoday | SUNDAY • 22 MAY 2022 NEWS Cherubino gets shorter licence as NHS success rates plummet CONTINUED FROM PAGE 1 Upon analysing the rate of positive pregnancies from fresh embryo transfers, Malta's data already falls below the Euro- pean Society of Human Re- production and Embryology (ESHRE) mean pregnancy rate of 39% (2017) across Europe. From 2016 to 2020, the preg- nancy rate appears to have dipped from 25% to 17%, and that is without excluding mis- carriages in the first weeks of the pregnancy. That's a statistic that concerns fresh transfers of embryos, that is: a fertilised egg, that devel- ops into a blastocyst over the course of five days, and is then implanted into a woman. But there is a more serious fig- ure that raises eyebrow in the Embryo Protection Authority's latest annual report for 2020: the risk of OHSS at Mater Dei was of 50% – 51 cases out of 104 cycles – requiring all embryos to be frozen. OHSS is the most common complication related to assisted reproduction – it is what hap- pens to the female body when there is an exaggerated re- sponse to the excess hormones injected, required to stimulate the development of eggs in the ovaries, causing the ovaries to swell and become painful. In general, OHSS is avoida- ble when 10-12 eggs produced; the risk becomes more present when over 15 eggs are pro- duced. If this "risk" rate is present for every other woman who un- dergoes IVF at Mater Dei, then questions start being raised about hospital procedures to stimulate women's ovaries. Be- cause that is a process that ul- timately leads to the freeze-all option: a process that pays the Cherubino PPP more since it gets paid for each embryo fro- zen. Across Europe, the reported incidence rate of OHSS is 0.2%. But that's a comparison that the Superintendence for Public Health, Mater Dei, and the EPA are refusing. The EPA claims it is reporting "risk" of OHSS, not "incidence". Therefore it sees no need to in- vestigate Mater Dei's 'freeze all' option in the 50% cases of the 2020 cycles. The Superintendence, which actually licences the Cherubi- no PPP, insists there were no reports for "serious adverse events of OHSS". Additionally, Mater Dei says it has achieved a zero-OHSS clinic in the last three years, through "meticu- lous clinical vetting". That does not explain why Ma- ter Dei's doctors are reporting a high "risk" rate in the first place in half of the 2020 cycles, which meant suspending the embryo transfer until the mother's hor- mone levels are restored. In the meantime, all embryos and eggs are frozen. Frozen embryos at a fee When eggs are harvested from a woman, Maltese law will al- low just five eggs to be fertilised with sperm. A typical harvest is of 10-12 eggs. The excess eggs are frozen. Not all of the five fertilised eggs will develop into good quality embryos. Only a maxi- mum two embryos will be im- planted at any one time in a woman. The rest of the embry- os will be frozen. In 2014, Cherubino was awarded the €1.57 million contract to set up the theatre, laboratory and storage areas that complemented MDH's in- frastructure. But in this PPP model, it is the government provides the medical human re- sources for the provision of the IVF service, not the Cherubino licensee. Cherubino provides clerical services to process the IVF lab How IVF works 1. Stimulation medication to generate 10-12 eggs with daily injections 2. Eggs are harvested from woman's ovaries 3. Maximum 5 eggs fertilised with sperm; not all will develop into embryos 4. Embryo develops into blastocyst over five days. Two 'good quality' embryos will be implanted in woman What is OHSS? Ovarian hyperstimulation syndrome is an exaggerated response to excess hormones, usually occurring in women taking injectable hormone medications to stimulate the development of eggs in the ovaries. OHSS causes the ovaries to swell and become painful. Symptoms often begin within a week after using injectable medi- cations to stimulate ovulation, and can range from mild to severe and may worsen or improve over time. Treatment depends on the severity of the condition. Having a high level of human chorionic gonadotropin (HCG) — a hormone usually produced during pregnancy — introduced into the system plays a role. Ovarian blood vessels react abnormally to HCG and begin to leak fluid. This fluid swells the ovaries, and some- times large amounts move into the abdomen. During IVF, all the follicles may be removed from the ovaries to reduce the chance of OHSS. Mature follicles are fertilized and fro- zen, and the ovaries are allowed to rest. Women resume the IVF process at a later date, when their body is ready. SOURCE: MAYO CLINIC After OHSS risk is identified, embryos and eggs are frozen 1. As fertilised eggs develop into blastocysts over five days, once OHSS suspends the transfer, these embryos will have to be frozne, along with the additional eggs 2. Not all five embryos will develop into blastocysts 3. After OHSS subsides, the embryos are thawed for transfer (max. 2) Cherubino will charge over €11,000 for this entire process where embryos will have to be frozen due to OHSS risk