CClinicalTrials.gg
CompletedNCT02815371Updated Jun 28, 2016

Laser Acupuncture Before and After Embryo Transfer Improves IVF Outcomes

An interventional study of Needle Acupuncture and Laser Acupuncture in Embryo Implantation, sponsored by Reproductive Medicine Associates of New Jersey. Completed at 2 sites in United States. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2016-06-28.

Sponsored by Reproductive Medicine Associates of New Jersey · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
803
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Embryo Implantation
03

In context

Lead sponsor

Reproductive Medicine Associates of New Jersey is the lead sponsor of 54 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • All patients seeking pregnancy via in vitro fertilization during the study period

Exclusion criteria

Exclusion Criteria:

  • Bleeding disorders (due to the possible use of needles)
  • Prior exposure to acupuncture
  • Preimplantation genetic screening or diagnosis
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
803 participants (actual)

Study arms

  • 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

  • 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

  • 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

  • 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.

Interventions

  • ProcedureNeedle Acupuncture

    See above

  • ProcedureLaser Acupuncture

    See above

  • ProcedureSham Laser Acupuncture

    See above

06

What researchers measure

Primary outcomes

  1. Implantation rate

    Number of gestational sacs seen on ultrasound per embryo transferred

    Time frame: Approximately 2 weeks after embryo transfer

Secondary outcomes

  1. Clinical pregnancy rate

    Number of pregnancies per embryo transfer procedure

    Time frame: Approximately 3 weeks after embryo transfer

  2. Live birth rate

    Number of deliveries of at least on live newborn per embryo transfer procedure

    Time frame: 40 weeks after intervention

07

Study locations

2 sites
  • Reproductive Medicine Associates of Connecticut
    Norwalk, Connecticut 06850, United States
  • Reproductive Medicines Associates of New Jersey
    Morristown, New Jersey 07960, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 28, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02815371
Lead sponsor
Reproductive Medicine Associates of New Jersey
Responsible party
Sponsor
First posted
Jun 28, 2016
Start date
Jun 2005
Primary completion
Jan 2008
Completion
Jan 2008
Last update
Jun 28, 2016
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.

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