scholarly journals Effectiveness of Electroacupuncture for Thin Endometrium in Infertile Women: Study Protocol for A Single-Blind, Randomized Controlled Trial

2020 ◽  
Author(s):  
Fangyuan Li ◽  
Hua Lu ◽  
Xinxin Wang ◽  
Qi Zhang ◽  
Qianchen Liu ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Pregnancy Rate ◽  
Controlled Trial ◽  
Resistance Index ◽  
Endometrial Receptivity ◽  
Trial Registration ◽  
Controlled Clinical Trial ◽  
Thin Endometrium ◽  
Infertile Women ◽  
Randomized Controlled

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

scholarly journals Effectiveness of electroacupuncture for thin endometrium in infertile women: study protocol for a single-blind, randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Fangyuan Li ◽  
Hua Lu ◽  
Xinxin Wang ◽  
Qi Zhang ◽  
Qianchen Liu ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Pregnancy Rate ◽  
Endometrial Thickness ◽  
Controlled Trial ◽  
Resistance Index ◽  
Endometrial Receptivity ◽  
Controlled Clinical Trial ◽  
Thin Endometrium ◽  
Infertile Women ◽  
Randomized Controlled

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

scholarly journals Follicular flushing leads to higher oocyte yield in monofollicular IVF: a randomized controlled trial

2020 ◽  
Vol 35 (10) ◽  
pp. 2253-2261
Author(s):  
A S Kohl Schwartz ◽  
I Calzaferri ◽  
M Roumet ◽  
A Limacher ◽  
A Fink ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Pregnancy Rate ◽  
Transfer Rate ◽  
Controlled Trial ◽  
Trial Registration ◽  
Randomized Controlled ◽  
Follicular Aspiration ◽  
Oocyte Yield ◽  
Single Lumen ◽  
Significant Difference

Abstract STUDY QUESTION Does follicular flushing increase the number of mature oocytes in monofollicular IVF? SUMMARY ANSWER Follicular flushing increases the number of mature oocytes in monofollicular IVF. WHAT IS KNOWN ALREADY Flushing increases neither the oocyte yield nor the pregnancy rate in polyfollicular IVF or in poor responder patients. In monofollicular IVF, the effect of flushing has so far been addressed by two studies: (i) a prospective study with minimal stimulation IVF demonstrated an increased oocyte yield, and (ii) a retrospective study with natural cycle (NC)-IVF showed an increased oocyte yield and an increased transfer rate. STUDY DESIGN, SIZE, DURATION Randomized controlled trial including 164 women who were randomized for either aspiration with or without flushing from 2016 to 2019. PARTICIPANTS/MATERIALS, SETTING, METHODS Infertile women 18–42 years of age with an indication for IVF treatment at a university-based infertility unit. Women undergoing monofollicular IVF were randomized to either follicular aspiration only or follicular aspiration directly followed by five follicular flushes at a 1:1 ratio. The intervention was done without anaesthesia, using a gauge 19 single-lumen needle. Flushing volume was calculated (sphere formula) based on the size of the follicle. MAIN RESULTS AND THE ROLE OF CHANCE A total of 164 women were included; 81 were allocated to ‘aspiration only’ and 83 to additional ‘flushing’. Primary analysis was based on the intention-to-treat: oocyte yield, defined as the collected mature oocyte rate, was higher (n = 64/83, 77.1%) in the flushing group compared to the aspiration only group (n = 48/81, 59.3%, adjusted risk difference (RD): 18.2% (95% CI 3.9–31.7%), P-value = 0.02). In the flushing group, most oocytes were retrieved within the first three flushes (63/83, 75.8%). Fertilization rate was higher in the flushing group (n = 53/83, 63.9% vs n = 38/81, 46.9%; adjusted RD: 16.8% (96% CI 1.5–31.4%), P = 0.045). Transfer rate was also higher in the flushing group (n = 52/83, 62.7% vs n = 38/81, 46.9%; RD: 15.71 (95% CI 0.3–30.3%)), but the difference was not significant (P = 0.06). The clinical pregnancy rate n = 9/83 versus n = 9/81 (RD: −0.3% (95% CI −9.9% to 9.5%)) and live birth rate n = 7/83 versus n = 8/81 (RD: −1.5% (95% CI −10.4% to 7.1%)) were not significantly different between the flushing and the aspiration group. The median duration of the intervention was significantly longer with flushing (2.38 min; quartiles 2.0, 2.7) versus aspiration only (0.43 min; quartiles 0.3, 0.5) (P < 0.01). There was no significant difference in the mean (±SD) visual analogue scales pain score between the follicular flushing (3.4 ± 1.8) and the aspiration group (3.1 ± 1.89). LIMITATIONS, REASONS FOR CAUTION Blinding of the procedure was not possible. WIDER IMPLICATIONS OF THE FINDINGS Our study proved that flushing of single follicles in NC-IVF increases the oocyte yield. In contrast to polyfollicular IVF flushing seems to be beneficial in a monofollicular setting if the technique used in our study (single-lumen needle, 5 flushings with flushing volume adaptation) is applied. STUDY FUNDING/COMPETING INTEREST(S) The study was funded by the financial sources of the division and in part by a research grant provided by NMS Biomedical SA, Switzerland. The company did not have any roles in design or conduct of the study or in the preparation of the manuscript. The authors have no other conflicts of interest. TRIAL REGISTRATION NUMBER Clinicaltrials.gov NCT 02641808. TRIAL REGISTRATION DATE 29 December 2015 DATE OF FIRST PATIENT’S ENROLMENT 22 August 2016

scholarly journals Japanese health and safety information for overseas visitors: protocol for a randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Mariko Nishikawa ◽  
Masaaki Yamanaka ◽  
Akira Shibanuma ◽  
Junko Kiriya ◽  
Masamine Jimba
Keyword(s):  
Health Care ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Safety Information ◽  
Intervention Group ◽  
Health And Safety ◽  
Trial Registration ◽  
Control Group ◽  
Internet Portal ◽  
Randomized Controlled

Abstract Background Before the COVID-19 pandemic occurred in January 2020, the number of overseas visitors to Japan had increased threefold over the last decade. To minimize the risk of health problems, visitors should be able to access information on the health care systems of the places they visit. Most short-term overseas visitors are young adults. Although they are not very likely to get sick from noncommunicable diseases, they are at high risk for injury and often experience stomach ailments, fever, or nausea when travelling. The objective of this study is to evaluate culturally and linguistically appropriate health information on preventive health behaviours and the health care system in Japan. We will examine the level of satisfaction of overseas visitors to Japan with health care-related educational materials using a five-minute digital game named Sa-Chan Japan. Methods Our study is a randomized controlled trial (RCT). We will assess both satisfaction and motivation before, during, and after the interventions and examine the changes over time. The intervention group will comprise overseas visitors who will view and answer questions in an animation named Sa-Chan Japan. The control group will comprise overseas visitors who will watch an English digital animation named Mari Info Japan. We will recruit 1002 participants through the Macromill Internet portal. We will contact overseas visitors who have either visited or wish to visit Japan from the United Kingdom, United States, and Australia. The participants will fill out a self-administered questionnaire online in the first quarter of 2021. We will determine the participants’ levels of satisfaction with the CSQ-8 (8-item Client Satisfaction Questionnaire). We will analyse the median score of the overseas visitors with both the Wilcoxon rank-sum and the Wilcoxon signed-rank tests. Our protocol of randomized controlled trials follows the SPIRIT guidelines. Discussion Our research will utilize unique digital education strategies in a game that promotes health and safety among overseas visitors to Japan. We believe the results of this study will be useful in overcoming the current challenges regarding pretravel health requirements for overseas visitors worldwide. Trial registration Version 1 of this trial was registered in the UMIN-CTR (University Hospital Medical Information Network Center Clinical Trials Registry), and the trial registration data are available on UMIN000042483, November 17, 2020.

scholarly journals Clinical validation of pinopode as a marker of endometrial receptivity: a randomized controlled trial

2017 ◽  
Vol 108 (3) ◽  
pp. 513-517.e2 ◽  
Author(s):  
Zhang Qiong ◽  
Hao Jie ◽  
Wang Yonggang ◽  
Xu Bin ◽  
Zhao Jing ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Endometrial Receptivity ◽  
Clinical Validation ◽  
Randomized Controlled

Mindfulness-based program for stress reduction in infertile women: Randomized controlled trial

2018 ◽  
Vol 35 (1) ◽  
pp. 49-58 ◽  
Author(s):  
Simone F. Nery ◽  
Sara P.C. Paiva ◽  
Érica L. Vieira ◽  
Andressa B. Barbosa ◽  
Edna M. Sant'Anna ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Stress Reduction ◽  
Controlled Trial ◽  
Infertile Women ◽  
Randomized Controlled

scholarly journals Nutritional support for lactating women with or without Azithromycin for infants compared to breast-feeding counselling alone, to improve six-month growth outcomes among infants of peri-urban slums of Karachi, Pakistan – a protocol of multi-arm assessor blinded randomized controlled trial (Mumta LW trial)

2020 ◽  
Author(s):  
Ameer Muhammad ◽  
Yasir Shafiq ◽  
M Imran Nisar ◽  
Benazir Baloch ◽  
Amna Tanweer Yazdani ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Low Income ◽  
Controlled Trial ◽  
Intervention Group ◽  
Relative Length ◽  
Trial Registration ◽  
Control Group ◽  
Lactating Women ◽  
Randomized Controlled ◽  
Increased Risk

Abstract BackgroundGlobally, 45% of under-five deaths are, directly or indirectly, attributable to malnutrition, most of these deaths are in low- and middle-income countries (LMICs). Children in the first 6 months of life are particularly vulnerable. An estimated 4.7 million infants under the age of 6 months are moderately wasted whereas 3.8 million are severely wasted. Despite the increased risk to a child of a mother with nutritional decompensation, there are discrepancies in guidance in this area. MethodsThis is a community-based, open-label factorial randomized controlled trial, using parallel assignment with 1:1:1 allocation ratio, in low-income squatter settlements of urban Karachi, Pakistan. In the control group (Arm A), women are randomized to standard counseling only; whereas in the first intervention group (Arm B), lactating women receive two sachets of balanced energy-protein (BEP) supplementation per day from enrollment till the infant reaches six months of age, in the second intervention group (Arm C), lactating women receive same BEP as in intervention Arm B while their babies also receive a single stat dose (20mg/kg orally) of azithromycin at 42 days. The primary outcome is relative length velocity from 0 to 6 months by the limb of allocation. The primary analysis will be Intention-to-treat analysisTrial registrationRegistration of the trial is done at ClinicalTrials.gov. NCT03564652, registered on June 21, 2018. Trial registration data is available through https://clinicaltrials.gov/ct2/show/NCT03564652

Sign in / Sign up

Export Citation Format

Share Document