Ovarian Hyperstimulation Syndrome: The STOP-OHSS RCT of outpatient paracentesis and survey on preventive practices

IntroductionOvarian Hyperstimulation Syndrome (OHSS) is a potentially serious complication of ovarian stimulation and Assisted Reproductive Technologies. This study aimed to assess the effectiveness of early outpatient paracentesis in preventing symptom progression and hospitalisation of OHSS patients, and resulting in earlier resolution of the condition. MethodsA randomised controlled trial was conducted, randomly allocating fertility centre patients with moderate or severe OHSS to either conservative management (n = 5), or outpatient paracentesis with increased monitoring (n = 3). Randomisation was computer-generated, and the primary outcome was OHSS-related hospitalisation. Due to recruitment challenges, particularly pertaining to the SARS-CoV-2 (COVID-19) pandemic, the trial was closed early after randomising eight participants from three sites. A post-trial survey was conducted to examine changes in clinical practices at UK fertility centres during and after the COVID-19 pandemic. ResultsOf the eight participants, two were hospitalised for OHSS-related reasons. Six participants symptoms resolved during follow-up, while two had unknown outcomes. No significant adverse events related to paracentesis were reported. The post-trial survey, completed by 16 fertility centres, revealed that 31% of respondents believed OHSS incidence had decreased during and after COVID-19. Many centres reported increased use of preventive strategies during and after COVID-19. For example, 91% of sites reported that they increased their elective freeze rates; 53% increased their use of the antagonist protocol; and 53% increased their use of Gonadotropin-Releasing Hormone (GnRH) trigger for final oocyte maturation. ConclusionsThe small sample size precludes definitive conclusions, however, outpatient paracentesis appears to be a safe option for managing OHSS. The study highlights challenges in researching rare conditions with rapid disease progression. The survey demonstrated that these challenges may also be reflective of radical changes in practice during the pandemic, which may have decreased the risk of OHSS significantly. The trial registration number was ISRCTN71978064, and the project was funded by the National Institute for Health and Care Research Health Technology Assessment programme (NIHR128137).