Views on outpatient paracentesis and GnRH antagonists for ovarian hyperstimulation syndrome: a qualitative study of patients and healthcare professionals.

Abstract

BACKGROUND

Ovarian hyperstimulation syndrome is a significant complication of fertility treatment, where the ovaries become enlarged if they are overstimulated, resulting in fluid leakage. Ovarian hyperstimulation syndrome can be classified as mild, moderate or severe. Symptoms vary dependent on severity but can include abdominal swelling, pain, nausea and vomiting, and shortness of breath. Treatment typically consists of monitoring initially, with active intervention if the condition progresses to a severe state, requiring hospitalisation. This study explored the acceptability and feasibility of outpatient paracentesis, and of gonadotropin-releasing hormone antagonists, as early interventions for ovarian hyperstimulation syndrome.

METHODS

We conducted qualitative semi-structured interviews with healthcare professionals from fertility clinics (n = 8) and patients who had experienced ovarian hyperstimulation syndrome (n = 10) across six United Kingdom fertility clinics. Interviews explored views on the proposed treatment protocols, and potential barriers and facilitators to randomised controlled trials evaluating these treatments.

RESULTS

Both healthcare professionals and patients were supportive of the proposed trials. Key findings included that healthcare professionals recommended clarity on patient eligibility, hospitalisation criteria and consent procedures. Patients expressed a desire to be given more detailed information about potential trials and had mixed opinions on self-monitoring. There were some concerns from both parties about treatment risks, particularly the paracentesis. Healthcare professionals noted a shift to more preventative practice due to the COVID-19 pandemic.

CONCLUSIONS

Outpatient paracentesis and gonadotropin-releasing hormone antagonists were perceived as promising interventions. Potential concerns and recommendations around both acceptability and feasibility were raised, which were used to refine the treatment protocols for the Shaping and Trialling Outpatient Protocols for Ovarian Hyperstimulation Syndrome trial.

FUNDING

This article presents independent research funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme as award number NIHR128137.

Plain language summary

This study explored the views of healthcare professionals and patients on proposed treatments for ovarian hyperstimulation syndrome, which is a complication of fertility treatment. During fertility treatment, drugs are given to encourage the ovaries to produce more eggs; sometimes, the ovaries become overstimulated, becoming enlarged and releasing chemicals that affect the bloodstream and fluid in the body. Ovaries becoming overstimulated results in extra fluid being released around the body, leaking into the abdomen and, in severe cases, around the heart and lungs. The symptoms of ovaries becoming overstimulated vary depending on whether it is mild, moderate or severe. Symptoms generally include abdominal swelling or bloating, discomfort and nausea. As ovaries becoming overstimulated worsens, it can lead to increased pain, vomiting, shortness of breath, decreased urine output and, in rare cases, blood clots. The researchers were planning to conduct a trial to assess two potential treatments: outpatient paracentesis (a procedure to drain excess fluid) and gonadotropin-releasing hormone antagonist injections. The researchers interviewed eight healthcare professionals who work in fertility clinics, and ten patients, to ask their opinions on how these trials should be designed. Both healthcare professionals and patients generally supported the idea of these treatments, agreeing that more proactive management is needed. Healthcare professionals wanted clearer guidelines on how to tell how severe ovaries becoming overstimulated is and when to hospitalise patients. They also discussed a current trend towards using more cautious treatment which may prevent ovaries becoming overstimulated, to avoid hospital admissions during the COVID-19 pandemic. Patients suggested that more detailed information should be given to those who may take part in the trial. Patients’ opinions varied on whether they would like to monitor their own symptoms at home – some found it empowering, while others thought it would be difficult. However, most patients liked the idea of avoiding hospital stays unless their symptoms were bad. Both healthcare professionals and patients raised concerns about whether there were treatment risks, particularly for paracentesis, and from healthcare professionals only whether their service had the facilities to be able to carry out outpatient paracentesis. These findings highlighted the need for more training to address these concerns. The researchers used these findings to improve the treatment protocols and trial procedures for their later research trial (called Shaping and Trialling Outpatient Protocols for Ovarian Hyperstimulation Syndrome) on ovarian hyperstimulation syndrome management. This study highlights the importance of considering both healthcare professional and patient perspectives when developing new treatments and clinical trials.

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