Laser Acupuncture Before and After Embryo Transfer Improves IVF Outcomes

Not Applicable

Completed

• Conditions: Embryo Implantation
• Interventions: Procedure: Laser Acupuncture; Procedure: Needle Acupuncture; Procedure: Sham Laser Acupuncture

• Registration Number: NCT02815371
• Lead Sponsor: Reproductive Medicine Associates of New Jersey

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-06
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Study First Submitted: 2016-05-25
• Status Verified: 2016-06
• Study First Submitted QC: 2016-06-23
• Last Update Submitted: 2016-06-23
• Study First Posted: 2016-06-28
• Last Update Posted: 2016-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 803

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laser Acupuncture	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.
Needle Acupuncture	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.
Sham Laser Acupuncture	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.

Primary Outcome Measures

Name	Time	Method
Implantation rate	Approximately 2 weeks after embryo transfer	Number of gestational sacs seen on ultrasound per embryo transferred

Secondary Outcome Measures

Name	Time	Method
Clinical pregnancy rate	Approximately 3 weeks after embryo transfer	Number of pregnancies per embryo transfer procedure
Live birth rate	40 weeks after intervention	Number of deliveries of at least on live newborn per embryo transfer procedure

Trial Locations

Locations (2)

Reproductive Medicine Associates of Connecticut; 🇺🇸 Norwalk, Connecticut, United States

Reproductive Medicines Associates of New Jersey; 🇺🇸 Morristown, New Jersey, United States