Laser Acupuncture Before and After Embryo Transfer Improves IVF Outcomes

Study Overview
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Brief Summary
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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.

Official Title
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Laser Acupuncture Before and After Embryo Transfer Improves in Vitro Fertilization Outcomes

Conditions
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Embryo Implantation

Intervention / Treatment
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* Procedure: Needle Acupuncture
* Procedure: Laser Acupuncture
* Procedure: Sham Laser Acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients seeking pregnancy via in vitro fertilization during the study period Exclusion Criteria: Bleeding disorders (due to the possible use of needles) Prior exposure to acupuncture Preimplantation genetic screening or diagnosis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Needle Acupuncture<br>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. | Procedure: Needle Acupuncture<br>* See above<br>|
| Experimental: Laser Acupuncture<br>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. | Procedure: Laser Acupuncture<br>* See above<br>|
| Sham Comparator: Sham Laser Acupuncture<br>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. | Procedure: Sham Laser Acupuncture<br>* See above<br>|
| No Intervention: No Treatment<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implantation rate | Number of gestational sacs seen on ultrasound per embryo transferred | Approximately 2 weeks after embryo transfer | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy rate | Number of pregnancies per embryo transfer procedure | Approximately 3 weeks after embryo transfer | 
| Live birth rate | Number of deliveries of at least on live newborn per embryo transfer procedure | 40 weeks after intervention |