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<p>The Human Fertilisation and Embryology Act 1990 requires the Human Fertilisation
and Embryology Authority (HFEA) to investigate all serious adverse events that take
place in its licensed establishments and all serious adverse reactions to treatment
suffered by patients. The conditions of a HFEA licence require Persons Responsible
at licensed establishments to report all serious adverse events, including near misses,
and reactions to the HFEA. Licensed establishments are required to report any serious
adverse reactions to treatment, that they are made aware of, even if the patient is
no longer receiving fertility treatment. There is no duty on any other medical establishment
to make reports to the HFEA.</p><p> </p><p>Cases of severe or critical Ovarian Hyperstimulation
Syndrome (OHSS) are considered to be serious adverse reactions to treatment. The information
requested is shown in the following table:</p><table><tbody><tr><td><p><strong> </strong></p></td><td><p>Mild*</p></td><td><p>Mild/moderate*</p></td><td><p>Moderate*</p></td><td><p>Moderate*/severe</p></td><td><p>Severe</p></td><td><p>Critical</p></td></tr><tr><td><p>2011</p></td><td><p>96</p></td><td><p>21</p></td><td><p>65</p></td><td><p>9</p></td><td><p>46</p></td><td><p>0</p></td></tr><tr><td><p>2012</p></td><td><p>41</p></td><td><p>20</p></td><td><p>93</p></td><td><p>10</p></td><td><p>33</p></td><td><p>0</p></td></tr><tr><td><p>2013</p></td><td><p>40</p></td><td><p>22</p></td><td><p>85</p></td><td><p>7</p></td><td><p>46</p></td><td><p>0</p></td></tr><tr><td><p>2014</p></td><td><p>41
(one intrauterine insemination)</p></td><td><p>8</p></td><td><p>50</p></td><td><p>14</p></td><td><p>34</p></td><td><p>0</p></td></tr><tr><td><p>2015</p></td><td><p>20</p></td><td><p>8</p></td><td><p>42</p></td><td><p>11</p></td><td><p>56</p></td><td><p>0</p></td></tr><tr><td><p>2016</p></td><td><p>29</p></td><td><p>12</p></td><td><p>46</p></td><td><p>5</p></td><td><p>40</p></td><td><p>0</p></td></tr><tr><td><p>2017</p></td><td><p>24</p></td><td><p>11</p></td><td><p>42</p></td><td><p>7</p></td><td><p>47</p></td><td><p>0</p></td></tr><tr><td><p>2018
(to 14 November 2018)</p></td><td><p>14</p></td><td><p>7</p></td><td><p>27</p></td><td><p>5</p></td><td><p>75</p></td><td><p>0</p></td></tr></tbody></table><p>Source:
HFEA</p><p> </p><p>Notes:</p><ol><li>The HFEA only requires clinics to report cases
of severe or critical OHSS, although some clinics do report mild through to moderate
cases. For that reason, this is not a complete picture of the occurrence of OHSS.</li><li>The
HFEA has advised that it believes the increase in the number of reports of severe
OHSS in 2018 is the result of clearer guidance in its code of practice, linking to
the Royal College of Obstetricians and Gynaecologists’ “Green Top” guidance on OHSS
that includes a severity grading definition</li></ol><p> </p><p>Identifying patient
information, held on the HFEA’s register, can only be disclosed without the patient’s
consent in very limited circumstances. The Government has no plans to lift those restrictions
to enable the data to be routinely linked with other health or mortality registers.</p>
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