Effect of acupuncture on women with poor ovarian response: a study protocol for a multicenter randomized controlled tria
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STUDY PROTOCOL
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Effect of acupuncture on women with poor ovarian response: a study protocol for a multicenter randomized controlled trial Huanfang Xu1†, Chensi Zheng1†, Liyun He2, Tongsheng Su3, Huidan Wang4, Yu Li5, Cui Zhao6, Cuilian Zhang7, Yang Bai8, Guoqing Tong9, Li Chen10, Fang Zhao11, Huisheng Yang1, Mingzhao Hao1, Yaqian Yin1, Li Yang1, Yigong Fang1* and Baoyan Liu2*
Abstract Background: Poor ovarian response (POR), a manifestation of low ovarian reserve and ovarian aging, leads to a significant reduction in the pregnancy rate after in vitro fertilization-embryo transfer. Acupuncture has increasingly been used to improve the ovarian reserve. The purpose of this study will be to evaluate the effect of acupuncture on increasing the number of retrieved oocytes after controlled ovarian hyperstimulation in women with POR. Methods: This will be a multicenter randomized controlled trial. A total of 140 women with POR will be randomly assigned to receive acupuncture or nontreatment for 12 weeks before controlled ovarian hyperstimulation. The primary outcome will be the number of retrieved oocytes. The secondary outcomes will be antral follicle counts, serum levels of anti-Müllerian hormone, basal serum levels of follicle stimulating hormone, luteinizing hormone and estradiol levels, scores from the self-rating anxiety scale, fertilization rates, cleavage rates, available embryo rates, and high-quality embryo rates. The safety of acupuncture will also be assessed. Discussion: The results of this trial will help to determine the effectiveness of acupuncture in the treatment of POR. This may provide a new treatment option for patients with POR and their physicians. Trial registration: AMCTR-IPR-18000198. Registered on 10 August 2018. Keywords: Acupuncture, Poor ovarian response, Number of retrieved oocytes, In vitro fertilization-embryo transfer, Randomized controlled trial
Background Poor ovarian response (POR) indicates a reduction in follicular response to the controlled ovarian hyperstimulation (COH) during in vitro fertilization (IVF) cycles, and it results in a reduced number of retrieved oocytes [1]. It is believed that approximately 9–24% of women * Correspondence: [email protected]; [email protected] † Huanfang Xu and Chensi Zheng are co-first authors. 1 Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences, Beijing, China 2 Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, China Full list of author information is available at the end of the article
who undergo IVF show POR during COH [2]. Women with POR usually experience less follicular development in COH cycles, low blood estrogen levels, high doses of gonadotrophin, high cycle cancelation rates, decreased numbers of retrieved follicles, and low rates of clinical pregnancy [3]. Therefore, POR often leads to an unsatisfactory outcome in assisted reproductive technology (ART), which seriously affects physical and mental health as well as quality of life. An in
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