Laser Acupuncture Before and After Embryo Transfer Improves in Vitro Fertilization Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 803
- 试验地点
- 2
- 主要终点
- Implantation rate
研究概览
简要总结
This study evaluated whether laser acupuncture at the time of embryo transfer (following in vitro fertilization) improves implantation rates. Patients were randomized to one of 4 groups at the time of embryo transfer: 1) laser acupuncture, 2) needle acupuncture, 3) sham laser acupuncture, 4) no treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All patients seeking pregnancy via in vitro fertilization during the study period
排除标准
- •Bleeding disorders (due to the possible use of needles)
- •Prior exposure to acupuncture
- •Preimplantation genetic screening or diagnosis
研究组 & 干预措施
No Treatment
This control group was not exposed to any additional physical contact or acupuncture related protocol. They were only exposed to dim light and calming music before and after embryo transfer, mimicking the natural waiting room and procedure room setting for all patients undergoing embryo transfer.
Needle Acupuncture
Sterile, disposable needles were inserted into specific acupoints until Deqi sensation was elicited. The needles were retained for 25 minutes before and after embryo transfer.
干预措施: Needle Acupuncture (Procedure)
Laser Acupuncture
Each point was stimulated with a laser (Luminex Laser Therapy System: Medical Laser Systems, Branford, CT) set at 5 joules/cm2 (J/cm2) in continuous mode for 0.10 seconds. Based on various studies, a minimum of 4 J/cm2 produces an improved circulatory effect.
干预措施: Laser Acupuncture (Procedure)
Sham Laser Acupuncture
However, support staff uninvolved in the design of the trial or analysis of the data disarmed the machine, such that no laser irradiation was emitted. This system created an illusion for both the patient and the acupuncturist, and allowed for a truly double blinded control group.
干预措施: Sham Laser Acupuncture (Procedure)
结局指标
主要结局
Implantation rate
时间窗: Approximately 2 weeks after embryo transfer
Number of gestational sacs seen on ultrasound per embryo transferred
次要结局
- Clinical pregnancy rate(Approximately 3 weeks after embryo transfer)
- Live birth rate(40 weeks after intervention)