Efficacy of acupuncture in improving ovarian function in patients with Poor Ovarian Response: study protocol for a randomized clinical trial

Abstract Introduction: Poor Ovarian Response(POR) is a serious and intractable clinical problem that reduces egg success and pregnancy outcomes in assisted reproduction, so there is an urgent need to find an effective treatment in addition to pharmacological therapies. Several studies have shown that acupuncture has the ability to improve ovarian function in women, but there is a paucity of research on acupuncture in ovarian POR, and it is worth exploring the clinical protocol and mechanisms of efficacy of acupuncture. Methods and analysis: This is a randomised controlled clinical trial protocol and the participants in this study will be female patients aged 30-45 years old undergoing IVF assisted reproduction for POR. Patients will be randomly assigned to trial and control groups by computer-generated sequences, and the groups in this study are: trial group: acupuncture + COS group (Group A), control group: non-meridian, non-acupuncture point placebo acupuncture + COS group (Group B) and COS alone group (Group C). All three groups received the same ovulation induction treatment. In addition, Group A received 8 weeks of real acupuncture treatment, Group B received 8 weeks of non-menstrual, non-acupoint comfort acupuncture treatment, and Group C did not receive any treatment before ovulation promotion. Sex hormone 6 was measured on the second day of menstruation in the month of registration and on the second day of menstruation in the month of the ovulation promotion cycle, and the number of sinus follicles was examined by transvaginal ultrasound in the three groups, respectively. The main observations of this trial will be the number of eggs retrieved and embryological parameters, and the patients' peripheral blood, follicular fluid and stool will be tested. The final data will be analysed by t-test or non-parametric test. Ethics and dissemination: The study protocol was approved by the Ethics Committee of the University Hospital of Chengdu University of Traditional Chinese Medicine (Ethics Approval No. 2023KL-019) and registered in a publicly accessible database. This study was supported by an institutional grant from Chengdu University of Traditional Chinese Medicine. The results of the study will be presented through peer-reviewed publications and conference presentations. Trial registration number: ChiCTR2300077441