Question
To ask Her Majesty’s Government, further to the Written Answers by Lord Prior of Brampton on 10 May (HL7949) and 25 May (HL152), what actions are taken against clinics where women have been hospitalised due to severe ovarian hyperstimulation syndrome (OHSS) in order to prevent future incidents; how the Human Fertilisation and Embryology Authority (HFEA) advises clinics to adopt clinical protocols that should prevent OHSS; what assessment the HFEA has made of the implications of the randomized clinical trial recently published in Human Reproduction (Volume 31 Issue 6, pp. 1253-64) about the reduction of risks associated with OHSS; and in the light of their most recent answer indicating that the handling of OHSS is "primarily a matter for … professional standards" and not the HFEA, whether the HFEA follows all appropriate professional standards.
Answer
The Human Fertilisation and Embryology Authority (HFEA) has advised that severe or critical cases of ovarian hyperstimulation syndrome (OHSS) are treated as incidents. A clinic must submit an incident report to the HFEA whenever it is made aware of a severe case of OHSS requiring a hospital admission, that has a severity grading of severe or critical. The HFEA would expect the clinic to review the patient’s drug stimulation regime, treatment and predisposing factors for OHSS, and to revise its practice and protocols where appropriate. This review is expected to be submitted to the HFEA within 10 working days from the date the incident was reported. The clinic’s report is reviewed by the Authority’s inspectorate and the clinical governance lead and, where appropriate, further enforcement action may be taken or relevant authorities contacted.
The article referred to by the noble Lord is concerned with effectiveness of particular drug protocols, which are not within the HFEA’s powers of enforcement.
The HFEA has also advised that, under good medical practice, it would expect doctors to treat patients on an individual basis and assess their risk of developing OHSS before treatment commences and also through monitoring the treatment cycle as it progresses. As stated in my Written Answer of 25 May 2016 (HL152), professional clinical standards are set by the appropriate Royal Colleges and issued to guide clinicians and health professionals directly, not the HFEA.