Abstract
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.
Highlights
Diminished ovarian reserve (DOR) is the precursor state of ovarian failure and can cause the decline of women’s reproductive function
A clinical trial finds that when undergoing In-vitro fertilization-embryo transfer (IVF-ET), the DOR patients’ initial dose of gonadotropin (Gn), total Gn, Gn days, and abortion rate are obviously higher than patients with normal ovarian function, but the oocytes, M II oocytes rate, high qualified embryo rate, fertilization rate, implantation rate, and pregnancy rate are all distinct inferior to patients with normal ovarian function [1]
Through this study, we expect to test the following hypotheses: (1) evaluate whether electro-acupuncture is superior to the control group in ameliorating ovarian function of DOR patients reflected by improving clinical pregnancy rate, and (2) assess the safety of electroacupuncture
Summary
Diminished ovarian reserve (DOR) is the precursor state of ovarian failure and can cause the decline of women’s reproductive function. 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. A clinical trial finds that when undergoing IVF-ET, the DOR patients’ initial dose of gonadotropin (Gn), total Gn, Gn days, and abortion rate are obviously higher than patients with normal ovarian function, but the oocytes, M II oocytes rate, high qualified embryo rate, fertilization rate, implantation rate, and pregnancy rate are all distinct inferior to patients with normal ovarian function [1]. It leads to perimenopause-related symptoms, such as hot flashes, night sweats, irritability, etc All these symptoms impact on patients’ quality of life.
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