Laser Acupuncture Before and After Embryo Transfer Improves IVF Outcomes

Reproductive Medicine Associates of New Jersey

Status: Completed

Conditions: Embryo Implantation

Treatments: Procedure: Laser Acupuncture; Procedure: Sham Laser Acupuncture; Procedure: Needle Acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT02815371

RMA-00-03

Details and patient eligibility

About

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.

Enrollment: 803 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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803 participants in 4 patient groups

Needle Acupuncture

Experimental group

Description:

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.

Treatment:

Procedure: Needle Acupuncture

Laser Acupuncture

Experimental group

Description:

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.

Treatment:

Procedure: Laser Acupuncture

Sham Laser Acupuncture

Sham Comparator group

Description:

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.

Treatment:

Procedure: Sham Laser Acupuncture

No Treatment

No Intervention group

Description:

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.