Evaluation of Acupuncture's Effectiveness on Pregnancy Outcomes in Women with Recurrent Implantation Failure RIF: a Large Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,969
- 试验地点
- 1
- 主要终点
- Clinical Pregnancy Rate (CPR)
研究概览
简要总结
Title: Evaluating the Effectiveness of Acupuncture on Pregnancy Outcomes in Recurrent Implantation Failure (RIF) Patients Undergoing In Vitro Fertilization (IVF): A Large Cohort Study
Objective:
This study aims to assess the efficacy of acupuncture in improving pregnancy outcomes, including clinical pregnancy rate (CPR), ongoing pregnancy rate (OPR), and live birth rate (LBR), in patients who have experienced recurrent implantation failure (RIF) during frozen embryo transfer (FET) cycles.
Background:
Recurrent implantation failure (RIF) is a significant challenge in assisted reproductive technologies (ART), affecting approximately 15% of IVF patients. The causes of RIF include uterine factors, embryo quality issues, and immune dysfunctions. Acupuncture, a traditional Chinese medical practice, has gained interest as an adjunctive treatment in IVF, potentially enhancing uterine blood flow, regulating hormones, and alleviating stress. While previous studies suggest a positive impact of acupuncture on IVF outcomes, its role in patients with RIF remains unclear, particularly in Vietnam, where its integration into modern fertility treatments is emerging.
Methods:
Design: Retrospective cohort study. Setting: IVF Department, Hung Vuong Hospital, Ho Chi Minh City. Participants: 1,969 IVF cycles from RIF-diagnosed patients between January 2019 and December 2023, divided into two groups: those who received acupuncture and those who did not.
Interventions:
Acupuncture sessions were performed 25 minutes before and after embryo transfer, targeting specific acupoints (e.g., Baihui, Guanyuan, Sanyinjiao).
Standardized hormonal protocols (HRT-E+P) and embryology practices were applied uniformly across all participants.
Outcome Measures: CPR, OPR, LBR, biochemical pregnancy rates, and miscarriage rates were analyzed.
Statistical Analysis:
Descriptive statistics summarized baseline characteristics. Logistic regression was used to evaluate the association between acupuncture and pregnancy outcomes, adjusting for potential confounders such as age, BMI, and number of prior failed cycles.
Results (Preliminary):
The study hypothesizes that patients receiving acupuncture will demonstrate improved CPR, OPR, and LBR compared to non-acupuncture counterparts. Previous research has suggested a trend toward higher clinical pregnancy rates with acupuncture, but statistical significance and the mechanisms behind these effects require further exploration.
Ethical Considerations:
Patient data were anonymized, and the study was approved by the institutional ethics committee. Participation was voluntary, with informed consent obtained prior to treatment.
Conclusions:
This research seeks to provide robust evidence on the integration of acupuncture into fertility treatment protocols for RIF patients, addressing a critical gap in both global and Vietnamese reproductive healthcare. If proven effective, acupuncture could become a valuable complementary therapy in enhancing IVF success rates.
This study represents a crucial step toward combining traditional and modern medical practices to improve reproductive outcomes.
详细描述
Study Title: Evaluating the Effectiveness of Acupuncture on Pregnancy Outcomes in Recurrent Implantation Failure (RIF) Patients Undergoing In Vitro Fertilization (IVF): A Large Cohort Study
Background:
Recurrent implantation failure (RIF) is a complex condition that poses significant challenges to the success of assisted reproductive technology (ART). Defined by the European Society of Human Reproduction and Embryology (ESHRE), RIF occurs when a clinical pregnancy is not achieved after the transfer of good-quality embryos in multiple IVF cycles. Causes include embryo quality, uterine abnormalities, immunological factors, and hormonal imbalances. The psychological and physical stress associated with repeated failures further complicates treatment.
Acupuncture, a traditional Chinese medicine practice, has been used for over 3,000 years to treat various conditions. In the context of infertility, acupuncture is believed to enhance uterine blood flow, regulate endocrine function, and reduce patient stress, thus creating a favorable environment for implantation. While prior studies have suggested that acupuncture may improve IVF outcomes, evidence specific to patients with RIF remains limited, particularly in Vietnam, where it has been integrated into modern reproductive medicine only recently.
Objective:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women diagnosed with recurrent implantation failure (RIF), defined as the absence of clinical pregnancy after at least three transfers of good-quality embryos.
- •Patients undergoing frozen embryo transfer (FET) cycles with at least one viable frozen embryo.
- •Endometrial preparation using hormone replacement therapy (HRT-E+P).
- •Complete consent form signed by both partners and the attending physician, as per IVF protocol at Hung Vuong Hospital.
- •Availability of complete clinical and embryological records from January 2019 to December 2023.
排除标准
- •Structural uterine abnormalities, including untreated septate uterus or uterine malformations.
- •Patients undergoing preimplantation genetic testing (PGT) cycles.
- •Use of donor eggs or sperm.
- •Presence of untreated endocrine disorders, including but not limited to hyperthyroidism, hypothyroidism, diabetes, and hypertension.
- •Patients lacking consent for data usage in the study or incomplete clinical records.
- •Criteria for Recurrent Implantation Failure (RIF)
- •Definition:
- •According to the European Society of Human Reproduction and Embryology (ESHRE), recurrent implantation failure (RIF) is defined as the inability to achieve a clinical pregnancy after transferring good-quality embryos across multiple in vitro fertilization (IVF) cycles.
- •Criteria for RIF Diagnosis:
- •Number of Transfers: Failure to achieve pregnancy after at least three embryo transfers (fresh or frozen), with a minimum of 1-2 good-quality embryos transferred each time.
- •Total Number of Embryos: Alternatively, RIF can be defined as failure to achieve pregnancy after transferring at least four good-quality embryos in total.
- •Possible Causes:
- •RIF can result from factors related to the embryo, uterus, or other conditions, such as:
- •Embryo quality issues (e.g., genetic abnormalities or poor development). Uterine abnormalities (e.g., insufficient endometrial thickness or structural anomalies).
- •Immunological or hematological factors affecting implantation. These criteria guide the identification of patients who may benefit from further investigation or specialized treatments, such as those evaluated in this study.
研究组 & 干预措施
IVF with Acupuncture Group: Patients undergoing IVF cycles with acupuncture performed before and aft
IVF with Acupuncture Group:
This group includes patients who underwent IVF cycles with acupuncture performed at two key time points:
Before Embryo Transfer: Acupuncture was administered 25 minutes prior to transfer at specific acupoints (e.g., Baihui, Guanyuan, Sanyinjiao) to enhance endometrial receptivity and reduce stress.
After Embryo Transfer: A second acupuncture session was conducted immediately following the transfer at additional acupoints (e.g., Zusanli, Taichong) to support implantation and relaxation.
IVF without Acupuncture Group:
This group includes patients who underwent IVF cycles without any acupuncture treatment. Their IVF procedures followed standard clinical protocols for frozen embryo transfer (FET), including hormonal preparation of the endometrium and embryo transfer, without any complementary therapies.
The study retrospectively compares clinical outcomes, including clinical pregnancy rate (CPR), ongoing pregnancy rate (OPR), and live birth rate (LBR), betwee
干预措施: Intervention Name: Acupuncture Therapy Before and After Embryo Transfer Description: The intervention involves acupuncture therapy performed at two key time points during the IVF cycle: 25 minutes be (Procedure)
结局指标
主要结局
Clinical Pregnancy Rate (CPR)
时间窗: 6-8 weeks post-embryo transfer.
The proportion of participants achieving a clinical pregnancy, defined as the presence of a gestational sac observed via ultrasound after frozen embryo transfer (FET).
次要结局
- Ongoing Pregnancy Rate (OPR)(12 weeks post-embryo transfer.)
- Live Birth Rate (LBR)(Approximately 9 months post-embryo transfer.)
研究者
Thi Thanh Thuy Tran, MD
Infertility Specialist, Department of Infertility, Hung Vuong Hospital
Hung Vuong Hospital