PDF(Pubmed)
Abstract：
UNASSIGNED: In vitro fertilization (IVF) is a technology that assists couples experiencing infertility to conceive children. However, unsuccessful attempts can lead to significant physical and financial strain. Some individuals opt for electro-acupuncture (EA) during IVF, even though there is limited evidence regarding the efficacy of this practice. Thus, this pilot study aims to explore the effectiveness and safety of EA during IVF on pregnancy outcomes.
UNASSIGNED: This clinical trial is a parallel, randomized, sham-controlled study. It aims to include a total of 118 infertile women who intend to undergo IVF. The participants will be randomly divided into three groups in a 1:1:1 ratio: the EA + IVF group, the placebo electro-acupuncture (pEA) +IVF group, and the IVF control group. All of the patients will be required to use ovarian stimulation drugs, while those in the EA + IVF and pEA + IVF groups will receive acupuncture treatment at three sessions per week (every other day) until trigger day with a minimum five session. The primary outcome of this trial will focus on the clinical pregnancy rate (CPR). CPR is defined as the rate of achieving clinical pregnancy from the first fresh/frozen embryo transfer cycle with an ultrasound-confirmed gestational sac in the uterine cavity. The secondary outcomes will assess embryology data, biochemical pregnancy rate, early miscarriage rate, Self-rating Anxiety Scale (SAS), Self-rating Depression Scale (SDS), Pittsburgh Sleep Quality Index (PSQI), Fertile Quality of Life (FertiQoL), patient retention rate, treatment adherence, and safety outcomes.
UNASSIGNED: Ethics approval was obtained from the Ethics Committee of Sichuan Jinxin Xi\'nan Women and Children Hospital (number 2021-007). The results will be disseminated through peer-reviewed publications. The participants gave informed consent to participate in the study before taking part in it.
UNASSIGNED: https://www.chictr.org.cn, identifier ChiCTR2300074455.
UNASSIGNED: This clinical trial is a parallel, randomized, sham-controlled study. It aims to include a total of 118 infertile women who intend to undergo IVF. The participants will be randomly divided into three groups in a 1:1:1 ratio: the EA + IVF group, the placebo electro-acupuncture (pEA) +IVF group, and the IVF control group. All of the patients will be required to use ovarian stimulation drugs, while those in the EA + IVF and pEA + IVF groups will receive acupuncture treatment at three sessions per week (every other day) until trigger day with a minimum five session. The primary outcome of this trial will focus on the clinical pregnancy rate (CPR). CPR is defined as the rate of achieving clinical pregnancy from the first fresh/frozen embryo transfer cycle with an ultrasound-confirmed gestational sac in the uterine cavity. The secondary outcomes will assess embryology data, biochemical pregnancy rate, early miscarriage rate, Self-rating Anxiety Scale (SAS), Self-rating Depression Scale (SDS), Pittsburgh Sleep Quality Index (PSQI), Fertile Quality of Life (FertiQoL), patient retention rate, treatment adherence, and safety outcomes.
UNASSIGNED: Ethics approval was obtained from the Ethics Committee of Sichuan Jinxin Xi\'nan Women and Children Hospital (number 2021-007). The results will be disseminated through peer-reviewed publications. The participants gave informed consent to participate in the study before taking part in it.
UNASSIGNED: https://www.chictr.org.cn, identifier ChiCTR2300074455.
摘要：
■体外受精（IVF）是一种帮助经历不孕症的夫妇怀孕的技术。然而,不成功的尝试可能会导致严重的身体和财务压力。有些人在试管婴儿期间选择电针（EA），尽管关于这种做法的有效性的证据有限。因此，这项初步研究旨在探讨体外受精(IVF)期间EA对妊娠结局的有效性和安全性.
■这项临床试验是平行的，随机化，假对照研究。它旨在包括总共118名打算接受IVF的不育妇女。参与者将以1:1:1的比例随机分为三组：EA+IVF组，安慰剂电针（pEA）+IVF组，和IVF对照组。所有患者都将被要求使用卵巢刺激药物，而EA+IVF和pEA+IVF组将每周三次（每隔一天）接受针灸治疗，直到触发日，至少五次。该试验的主要结果将集中在临床妊娠率（CPR）上。CPR定义为从第一个新鲜/冷冻胚胎移植周期开始，在子宫腔中超声确认的孕囊达到临床妊娠的速率。次要结果将评估胚胎学数据，生化妊娠率，早期流产率，焦虑自评量表(SAS),抑郁自评量表(SDS),匹兹堡睡眠质量指数（PSQI）肥沃的生活质量（FertiQoL），患者保留率，治疗依从性，和安全结果。
■伦理批准获得四川省金信西安妇女儿童医院伦理委员会（编号2021-007）。结果将通过同行评审的出版物传播。参与者在参加研究之前知情同意参加研究。
■https://www.chictr.org.cn,标识符ChiCTR2300074455。
■这项临床试验是平行的，随机化，假对照研究。它旨在包括总共118名打算接受IVF的不育妇女。参与者将以1:1:1的比例随机分为三组：EA+IVF组，安慰剂电针（pEA）+IVF组，和IVF对照组。所有患者都将被要求使用卵巢刺激药物，而EA+IVF和pEA+IVF组将每周三次（每隔一天）接受针灸治疗，直到触发日，至少五次。该试验的主要结果将集中在临床妊娠率（CPR）上。CPR定义为从第一个新鲜/冷冻胚胎移植周期开始，在子宫腔中超声确认的孕囊达到临床妊娠的速率。次要结果将评估胚胎学数据，生化妊娠率，早期流产率，焦虑自评量表(SAS),抑郁自评量表(SDS),匹兹堡睡眠质量指数（PSQI）肥沃的生活质量（FertiQoL），患者保留率，治疗依从性，和安全结果。
■伦理批准获得四川省金信西安妇女儿童医院伦理委员会（编号2021-007）。结果将通过同行评审的出版物传播。参与者在参加研究之前知情同意参加研究。
■https://www.chictr.org.cn,标识符ChiCTR2300074455。
