Embryo ImplantationNCT02815371
Laser Acupuncture Before and After Embryo Transfer Improves IVF Outcomes
A study testing Needle Acupuncture and Laser Acupuncture in people with Embryo Implantation, run by Reproductive Medicine Associates of New Jersey at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Embryo Implantation
- What is being tested?
- Needle Acupuncture and Laser Acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 803 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2005to Jan 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- All patients seeking pregnancy via in vitro fertilization during the study period
Who cannot join
- Bleeding disorders (due to the possible use of needles)
- Prior exposure to acupuncture
- Preimplantation genetic screening or diagnosis
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Reproductive Medicines Associates of New Jersey
Morristown, New Jersey, 07960
Reproductive Medicine Associates of Connecticut
Norwalk, Connecticut, 06850
About this study
Official title: 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.
- Conditions
- Embryo Implantation
- Being tested
- Needle Acupuncture, Laser Acupuncture, Sham Laser Acupuncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Needle AcupunctureProcedure or surgery
See above
Laser AcupunctureProcedure or surgery
See above
Sham Laser AcupunctureProcedure or surgery
See above
| Study group | Role | What they receive |
|---|---|---|
| Needle Acupuncture | Experimental | 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. Receives: Procedure: Needle Acupuncture |
| Laser Acupuncture | Experimental | 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. Receives: Procedure: Laser Acupuncture |
| Sham Laser Acupuncture | Sham comparator | 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. Receives: Procedure: Sham Laser Acupuncture |
| No Treatment | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Implantation rate
Number of gestational sacs seen on ultrasound per embryo transferred
Measured: Approximately 2 weeks after embryo transfer
Secondary outcomes (2)
Clinical pregnancy rate
Number of pregnancies per embryo transfer procedure
Measured: Approximately 3 weeks after embryo transfer
Live birth rate
Number of deliveries of at least on live newborn per embryo transfer procedure
Measured: 40 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2016 (estimated)
- Study startJun 2005
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Embryo ImplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 803 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reproductive Medicine Associates of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02815371
- Sponsor's protocol ID
- RMA-00-03
- Status last verified
- Jun 2016
- First submitted
- 25 May 2016
- Last updated
- 28 Jun 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laser Acupuncture Before and After Embryo Transfer Improves in Vitro Fertilization Outcomes
- ClinicalTrials.gov ID
- NCT02815371
- Acronym / sponsor ID
- RMA-00-03
- Conditions
- Embryo Implantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 803 participants (actual)
- Lead sponsor
- Reproductive Medicine Associates of New JerseyUniversity, hospital or other
- Study start
- Jun 2005
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 28 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Needle Acupuncture | Experimental | Procedure: Needle AcupunctureSterile, 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 | Experimental | Procedure: Laser AcupunctureEach 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 comparator | Procedure: Sham Laser AcupunctureHowever, 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 intervention | –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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All patients seeking pregnancy via in vitro fertilization during the study period
Key exclusion criteria (3 listed)
- Bleeding disorders (due to the possible use of needles)
- Prior exposure to acupuncture
- Preimplantation genetic screening or diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Needle AcupunctureSee above | Procedure or surgery | Needle Acupuncture |
| Laser AcupunctureSee above | Procedure or surgery | Laser Acupuncture |
| Sham Laser AcupunctureSee above | Procedure or surgery | Sham Laser Acupuncture |
Primary outcome
Implantation rate
Time frame: Approximately 2 weeks after embryo transfer
Number of gestational sacs seen on ultrasound per embryo transferred
2 secondary outcomes
Clinical pregnancy rate
Time frame: Approximately 3 weeks after embryo transfer
Live birth rate
Time frame: 40 weeks after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2016.
Related trials for Embryo Implantation
Recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic
RecruitingObservational study
dPmax for Predicting Right Ventricular Failure After Left Ventricular Assist Device Implantation
Ventricular Dysfunction, Right
RecruitingObservational study
Retrospectively Investigating Longitudinal Outcomes in MED-EL SONATA 2 Cochlear Implant Recipients.
Cochlear Implantation, Sensorineural Hearing Loss
Not yet recruitingObservational study
Evaluation of a Management Algorithm for TAVI Patients With Concomitant Mitral or Tricuspid Regurgitation
Aortic Stenosis, Mitral Regurgitation
Recruiting
Ambulatory Electrocardiographic Monitoring for the Detection of High-Degree Atrio-Ventricular Block in Patients With New-onset PeRsistent LEft Bundle Branch Block After Transcatheter Aortic Valve Implantation. The "MARE" Study
Aortic Valve Disease, Conduction Disturbances
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Needle Acupuncture and Laser Acupuncture in people with Embryo Implantation, run by Reproductive Medicine Associates of New Jersey at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implantation rate (time frame: Approximately 2 weeks after embryo transfer). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2016.