Clinical Research Directory

The Effectiveness of CPII for Infertility Induced by PCOS in China

Sponsor: Universiti Sains Malaysia

Summary

Polycystic ovary syndrome (PCOS) is a common endocrine disorder in women of reproductive age and is associated with metabolic, reproductive and mental health complications. Its prevalence has been reported to be between 5% and 15% in different studies, showcasing its significant impact on the reproductive health of Chinese women. A holistic approach to PCOS treatment that integrates physical, emotional, and mental health is lacking in China. The integration of counseling and personalized care into existing healthcare frameworks may have economic implications on patients with PCOS-induced infertility. This study aimed to compare the effectiveness of the counselling, personalized care, and counseling-personalized care-integrated interventions versus the current module on the clinical outcomes over six months among patients of PCOS-induced infertility. The primary outcomes are menstrual cycle, hormonal parameters, metabolic parameters, and biochemical pregnancy. The secondary outcomes include anxiety and depression, sleep quality, and patient satisfaction. This study also explored the perceived challenges and barriers among patients with PCOS-induced infertility and healthcare providers involved in counseling-personalized care-integrated interventions in China. The mixed-method sequential interpretative design was applied. The quantitative component involved a non-randomized controlled trial. A total of 192 patients were recruited by convenient sampling from reproductive medicine centers of four hospitals in Shandong Province. One hospital implemented each module. Data has been collected through a review of medical records and questionnaires. Descriptive statistical and repeated measure analysis of variance has been applied using SPSS version 28.0. The qualitative component involved the phenomenological approach of in-depth interviews of patients and healthcare providers involved in the counseling-personalized care-integrated interventions. Approximately 36 respondents were invited for online interviews via purposive sampling. A thematic analysis has been performed using Nvivo version 14.

Official title: The Effectiveness of Counselling and Personalized Care-Integrated Interventions for Infertility Induced by Polycystic Ovary Syndrome in China

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