Laser Acupuncture Before and After Embryo Transfer Improves IVF Outcomes

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

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.

Study Overview

• Status: Completed
• Conditions: Embryo Implantation
• Intervention / Treatment: Procedure: Needle Acupuncture; Procedure: Laser Acupuncture; Procedure: Sham Laser Acupuncture

• Study Type: Interventional
• Enrollment (Actual): 803
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Norwalk, Connecticut, United States, 06850
      • Reproductive Medicine Associates of Connecticut
  • New Jersey
    • Morristown, New Jersey, United States, 07960
      • Reproductive Medicines Associates of New Jersey

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: Needle Acupuncture; See above
Experimental: 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.	Procedure: Laser Acupuncture; See above
Sham Comparator: 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.	Procedure: Sham Laser Acupuncture; See above
No Intervention: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Reproductive Medicine Associates of New Jersey

Study record dates

Study Major Dates

• Study Start: June 1, 2005
• Primary Completion (Actual): January 1, 2008
• Study Completion (Actual): January 1, 2008

Study Registration Dates

• First Submitted: May 25, 2016
• First Submitted That Met QC Criteria: June 23, 2016
• First Posted (Estimate): June 28, 2016

Study Record Updates

• Last Update Posted (Estimate): June 28, 2016
• Last Update Submitted That Met QC Criteria: June 23, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: RMA-00-03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No