Effect of electro-acupuncture on ovarian function of women with diminished ovarian reserve: study protocol for a randomized controlled trial

Trials

Li Zhou¹  Yajun Hu¹  Lijuan Yang²  Lu Xu²  Dongmei Huang³  Hanwang Zhang³  Le Yang³  Ying Gao⁴ 

[1] First Hospital of Wuhan, 215 Zhongshan Avenue, Wuhan, Hubei, China;Reproductive Hospital, Jiangxi University of Traditional Chinese Medicine, 597 Shuangmashi Road, Nanchang, Jiangxi, China;Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1095 Jiefang Avenue, 430030, Wuhan, Hubei, China;Union Hospital, 1277 Jiefang Avenue, Wuhan, Hubei, China;

关键词: Electro-acupuncture;    Diminished ovarian reserve;    In vitro fertilization-embryo transfer;    Randomized controlled trial;    Study protocol;   

DOI  :  10.1186/s13063-021-05894-2

来源: Springer

【 摘 要 】

BackgroundDiminished ovarian reserve (DOR) is the precursor state of ovarian failure and can cause the decline of women’s reproductive function. DOR also leads to poor outcome of in vitro fertilization and embryo transfer (IVF-ET) by affecting the oocytes, high qualified embryo rate, pregnancy rate, etc. Some studies have demonstrated that acupuncture can improve ovarian function. But to date, there is limited evidence indicating that acupuncture or electro-acupuncture is efficient to DOR. This trial aims to evaluate the efficiency and safety of electro-acupuncture for the ovarian function and the following outcome of IVF-ET in DOR patients.MethodsThis will be a multicenter randomized controlled clinical trial. A total of more than 338 women with DOR will be randomly allocated to treatment and control groups in 1:1 ratio receiving acupuncture before undergoing IVF-ET. The primary outcome will be the clinical pregnancy rate per cycle of IVF-ET after acupuncture. The secondary outcomes will be ovarian reserve function, outcomes of IVT-ET, blood biochemical index, Massachusetts General Hospital Acupuncture Sensation Scale (MASS), scores from the self-rating anxiety and depression scale, quality of life, and pregnancy outcomes. The safety of acupuncture will also be assessed.DiscussionThe results of this trial may provide high-quality evidence regarding the effectiveness of electro-acupuncture in the treatment of DOR and following outcomes of IVF-ET. This will also help patients with DOR and their physicians by offering a new treatment option.Trial registrationChinese Clinical Trial Registry ChiCTR1900024626. Registered on 19 July 2019.

【 授权许可】

CC BY