Effect of Electro-acupuncture on Ovarian Function and Outcome of Ivf-et of Women With Diminished Ovarian Reserve: Study Protocol for a Randomized Controlled Trial.

Author(s):  
Le Yang ◽  
Hanwang Zhang ◽  
Li Zhou ◽  
Ying Gao ◽  
Lijuan Yang ◽  
...  

Abstract Background:Diminished 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.Methods:This 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.Discussion:The 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 registration:ChiCTR1900024626. Registered on 19 July 2019.

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Le Yang ◽  
Hanwang Zhang ◽  
Li Zhou ◽  
Ying Gao ◽  
Lijuan Yang ◽  
...  

Abstract Background Diminished 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. Methods This 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. Discussion The 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 registration Chinese Clinical Trial Registry ChiCTR1900024626. Registered on 19 July 2019.


Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Ling-Yu Qi ◽  
Yu Wang ◽  
Li-Qiong Wang ◽  
Yan-Fen She ◽  
Guang-Xia Shi ◽  
...  

Abstract Background Irritable bowel syndrome (IBS) is one of the most common functional gastrointestinal diseases. Although acupuncture has become a common alternative therapy for IBS, there is insufficient evidence for its effectiveness. This study was designed to assess the efficacy and feasibility of acupuncture in the treatment of IBS. Methods/design This is a multicenter randomized controlled clinical trial. According to the ratio of 1:1:1, 90 patients with irritable bowel syndrome will be randomly divided into specific acupoints (SA) group, non-specific acupoints (NSA) group, and non-acupoints (NA) group. All patients will be treated with acupuncture 12 times within 4 weeks and followed up for 8 weeks. The primary outcome is the response rate, the percentage of patients whose average value of worst abdominal pain is 30% better and the days of loose stool is 50% less than the baseline, at week 4 after randomization. The secondary outcomes include the response rates at other time points, IBS Symptom Severity Scale (IBS-SSS), Patient Health Questionnaire-9 depression scale (PHQ-9), IBS-Quality of Life scale (IBS-QOL), IBS Adequate Relief (IBS-AR), Abdominal Pain Score, Abdominal Bloating Score, Bristol Stool Score (BBS), blinding assessment, and credibility evaluation. Adverse events will be monitored and recorded during the trial. Trial registration Chictr.org.cn ChiCTR2000030670. Registered on 9 March 2020.


Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Fangyuan Li ◽  
Hua Lu ◽  
Xinxin Wang ◽  
Qi Zhang ◽  
Qianchen Liu ◽  
...  

Abstract Background Thin endometrium negatively impacts the reproductive function. Current treatments for thin endometrium do not always improve endometrial receptivity. Preliminary evidence suggests that electroacupuncture could have potential therapy for thin endometrium in infertile women. Thus, this randomized controlled trial was designed to test whether electroacupuncture can improve endometrial receptivity in infertile women with thin endometrium. Methods This study is a randomized, single-blinded, controlled, clinical trial. A total of 142 eligible patients will be recruited and randomly assigned to the electroacupuncture (EA) group or the sham electroacupuncture (SEA) group in a 1:1 ratio. Participants will receive 36 sessions over three menstrual cycles (12 weeks in total), with the same acupoint prescription. The primary outcome of this trial is endometrial thickness in the midluteal phase. The secondary outcomes include endometrial pattern, resistance index (RI) and pulsatility index (PI) of bilateral uterine artery and endometrium blood flow, serum estradiol (E2) and progesterone (P), and pregnancy rate. The pregnancy rate will be evaluated during a 6-month follow-up after completion of the trial. All other outcomes will be evaluated before treatment, during the treatment of 1st, 2nd, and 3rd menstrual cycle, and 6 months after treatment. Discussion If the outcome confirms the effectiveness of electroacupuncture for thin endometrium in infertile women, this treatment will be proposed for application in clinical practice. Trial registration Chinese Clinical Trials Registry ChiCTR2000029983. Registered on 18 February 2020


2020 ◽  
Author(s):  
Fangyuan Li ◽  
Hua Lu ◽  
Xinxin Wang ◽  
Qi Zhang ◽  
Qianchen Liu ◽  
...  

Abstract Background: Thin endometrium negatively impacts the reproductive function. Current treatments for thin endometrium do not always improve endometrial receptivity. Preliminary evidence suggests that electroacupuncture could have potential therapy for thin endometrium in infertile women. Thus, this randomized controlled trial was designed to test whether electroacupuncture can improve endometrial receptivity in infertile women with thin endometrium.Methods: This study is a randomized, single-blinded, controlled, clinical trial. A total of 142 eligible patients will be recruited and randomly assigned to the electroacupuncture (EA) group or the sham electroacupuncture (SEA) group in a 1:1 ratio. Participants will receive 36 sessions over three menstrual cycles (12 weeks in total), with the same acupoint prescription. The primary outcome of this trial is endometrial thickness in the midluteal phase. The secondary outcomes include endometrial pattern, resistance index (RI) and pulsatility index (PI) of bilateral uterine artery and endometrium blood flow, serum estradiol (E2) and progesterone (P), and pregnancy rate. The pregnancy rate will be evaluated during a six-month follow-up after completion of the trial. All other outcomes will be evaluated before treatment, during the treatment of 1st, 2nd, and 3rd menstrual cycle, and 6 months after treatment.Discussion: If the outcome confirms the effectiveness of electroacupuncture for thin endometrium in infertile women, this treatment will be proposed for application in clinical practice.Trial registration: Trial registration: Chinese Clinical Trials Registry, ChiCTR2000029983. Registered on 18 February 2020, http://www.chictr.org.cn


2021 ◽  
Author(s):  
Huanfang Xu ◽  
Mingzhao Hao ◽  
Chensi Zheng ◽  
Huisheng Yang ◽  
Yaqian Yin ◽  
...  

Abstract Background: Diminished ovarian reserve (DOR) is described as reduced fecundity. A satisfactory treatment is lacking despite the upward trend of the prevalence. Acupuncture has been reported as an alternative therapy for female infertility. The purpose of this study is to investigate the effect of acupuncture for women with DOR.Methods/Design: In this randomized controlled trial, a total of 120 women with DOR will be randomized to receive either acupuncture or sham acupuncture for 12 weeks. The primary outcome is the antral follicle counting (AFC).Discussion:This study is expect to investigate the effect of acupuncture versus superficial needling in improving ovarian reserve for women with DOR.Trial registration:Acupuncture-Moxibustion Clinical Trial Registry (ChiCTR1800014988).


2021 ◽  
Author(s):  
Qingchang Xia ◽  
Shuzhong Gao ◽  
Jingyan Song ◽  
Dongqing Du ◽  
Chunjing Li ◽  
...  

Abstract BackgroundRecurrent implantation failure (RIF) in the majority of patients undergoing in vitro fertilization and embryo transfer (IVF-ET) is caused by various factors such as maternal age, embryo quality, endometrial receptivity (ER) and immunity. The incidence of RIF is usually between 5and 10%. Previous studies have shown that herb-partitioned moxibustion on the navel is one of the treatment methods of acupuncture with a positive effect on pregnancy. However, its application in the treatment of RIF has not been reported. Therefore, this study aimed to explore the effectiveness of herb-partitioned moxibustion on the navel in improving the outcome of frozen embryo transfer (FET) in patients with RIF. MethodsThis study conducted a randomized controlled trial (RCT). It is planned to recruit 210 patients undergoing RIF for FET from Affiliated Hospital of Shandong University of Traditional Chinese Medicine and randomly divide them into the treatment group and the control group in a ratio of 1:1. The patient of the treatment group will be treated with herb-partitioned moxibustion on the navel once a week for three consecutive menstrual cycles. During the fourth menstrual cycle, will be induced to prepare the endometrium before embryo transfer. No intervention will be used in the control group for 3 menstrual cycles. However, in the fourth menstrual cycle, an artificial cycle will be induced to prepare the endometrium before embryo transfer. The conception outcome will be recorded after a 3-months follow-up. Primary outcome will be assessed as the ongoing pregnancy rate compared with the control group. Secondary outcomes include the endometrial type, resistance index (RI), pulsatility index (PI) of the bilateral uterine artery, endometrial blood flow, serum estradiol (E2), progesterone (P), biochemical pregnancy rate, implantation rate and clinical pregnancy rate. DiscussionIf the results confirm that the herb-partitioned moxibustion on the navel can improve IVF-ET outcomes in patients with RIF, it will be recommended for application in clinical practice.Trial registration:Chinese clinical trial registry (ChiCTR). Trial registration number: ChiCTR2100043954. Registered on 8 July 2021.


2021 ◽  
Vol 10 (24) ◽  
pp. 5941
Author(s):  
Mirian Santamaría-Peláez ◽  
Jerónimo Javier González-Bernal ◽  
Juan Carlos Verdes-Montenegro-Atalaya ◽  
Luis Ángel Pérula-de Torres ◽  
Ana Roldán-Villalobos ◽  
...  

In primary health care, the work environment can cause high levels of anxiety and depression, triggering relevant expert and individual change. Mindfulness-Based Stress Reduction (MBSR) programs reduce signs of anxiety and depression. The purpose of this sub-analysis of the total project, was to equate the effectiveness of the standard MBSR curriculum with the abbreviated version in minimizing anxiety and depression. This randomized controlled clinical trial enrolled 112 mentors and resident specialists from Family and Community Medicine and Nurses (FCMN), distributed across six teaching units (TU) of the Spanish National Health System (SNHS). Experimental group participants received a MBRS training (abbreviated/standard). Depression and anxiety levels were measured with the Goldberg Anxiety and Depression Scale (GADS) at three different time periods during the analysis: before (pre-test) and after (post-test) participation, as well as 3 months after the completion of intervention. Taking into account the pre-test scores as the covariate, an adjusted analysis of covariance (ANCOVA) showed significant depletion in anxiety and depression in general (F (2.91) = 4.488; p = 0.014; η2 = 0.090) and depression in particular (F (2, 91) = 6.653; p = 0.002; η2 = 0.128 at the post-test visit, maintaining their effects for 3 months (F (2.79) = 3.031; p = 0.050; η2 = 0.071—F (2.79) = 2.874; p = 0.049; η2 = 0.068, respectively), which is associated with the use of a standard training program. The abbreviated training program did not have a significant effect on the level of anxiety and depression. The standard MBSR training program had a positive effect on anxiety and depression and promotes long-lasting effects in tutors and resident practitioners. New research is needed to demonstrate the effectiveness of abbreviated versions of training programs.


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