Laser Acupuncture Before and After Embryo Transfer Improves IVF Outcomes
1 other identifier
interventional
803
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2005
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 25, 2016
CompletedFirst Posted
Study publicly available on registry
June 28, 2016
CompletedJune 28, 2016
June 1, 2016
2.6 years
May 25, 2016
June 23, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Implantation rate
Number of gestational sacs seen on ultrasound per embryo transferred
Approximately 2 weeks after embryo transfer
Secondary Outcomes (2)
Clinical pregnancy rate
Approximately 3 weeks after embryo transfer
Live birth rate
40 weeks after intervention
Study Arms (4)
Needle Acupuncture
EXPERIMENTALSterile, disposable needles were inserted into specific acupoints until Deqi sensation was elicited. The needles were retained for 25 minutes before and after embryo transfer.
Laser Acupuncture
EXPERIMENTALEach 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.
Sham Laser Acupuncture
SHAM COMPARATORHowever, 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.
No Treatment
NO INTERVENTIONThis 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
Eligibility Criteria
You may qualify if:
- All patients seeking pregnancy via in vitro fertilization during the study period
You may not qualify if:
- Bleeding disorders (due to the possible use of needles)
- Prior exposure to acupuncture
- Preimplantation genetic screening or diagnosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Reproductive Medicine Associates of Connecticut
Norwalk, Connecticut, 06850, United States
Reproductive Medicines Associates of New Jersey
Morristown, New Jersey, 07960, United States
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 25, 2016
First Posted
June 28, 2016
Study Start
June 1, 2005
Primary Completion
January 1, 2008
Study Completion
January 1, 2008
Last Updated
June 28, 2016
Record last verified: 2016-06