InfertilityNCT03981120
The Effect of Acupuncture on Pregnancy Rates in Women Undergoing in Vitro Fertilization With Preimplantation Genetic Screening
A study testing Laser and Traditional Acupuncture in people with Infertility and Aneuploidy, run by University of British Columbia.
Trial summary
While IVF offers an effective treatment for infertility, a significant proportion of IVF cycles still result in failed implantation and early miscarriage. As such, new therapies that improve pregnancy outcomes are highly desirable. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Infertility, Aneuploidy
- What is being tested?
- Laser and Traditional Acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2019to 1 Jan 2020
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- use of preimplantation genetic screening
- treatment with IVF/intracytoplasmatic sperm injection (ICSI)
- age <40
- BMI <35
Who cannot join
- three or more prior failed IVF cycles with euploid embryo transfer
- known structural or anatomic causes of infertility
- male factor infertility
- patients already receiving concomitant treatment within the last 3 months (e.g. reflexology, acupuncture, herbal supplements, meditation).
About this study
Official title: The Effect of Acupuncture on in Vitro Fertilization Outcomes in Women Undergoing Euploid Embryo Transfer - A Pilot Study
While IVF offers an effective treatment for infertility, a significant proportion of IVF cycles still result in failed implantation and early miscarriage. As such, new therapies that improve pregnancy outcomes are highly desirable. Both traditional and laser acupuncture during the IVF cycle has become a popular option for women looking to improve their pregnancy rates. However, studies looking to understand the effects of acupuncture on IVF have demonstrated contradicting results. While some studies show an improvement in pregnancy rates in women undergoing IVF with traditional acupuncture treatment, other studies show no difference. Moreover, there are few studies exploring the role of laser and traditional acupuncture in IVF cycles and the studies done thus far have shown no change in pregnancy rates. However, there have been no studies to-date that have looked at women who are receiving IVF for embryos with normal genetics. This is important because embryos with abnormal genetics are a major reason for failed implantation and miscarriage, which can make the effects of acupuncture on pregnancy rates difficult to evaluate. This study is a pilot study looking to better understand the role of laser and traditional acupuncture as a supplemental treatment in women undergoing euploid (normal genetics) embryo transfer. This is the first study to include only genetically normal embryos, which may help to better understand the effects of laser and traditional acupuncture on IVF outcomes.
Read the detailed description
Purpose:
To assess the feasibility and preliminary outcomes of a single-blinded randomized clinical trial evaluating the effect of laser and traditional acupuncture during the IVF cycle on pregnancy outcomes in women undergoing euploid embryo transfer.
Hypothesis:
A single-blinded randomized clinical trial evaluating the effects and reproductive outcomes of laser and traditional acupuncture during the IVF cycle will be acceptable to patients and feasible for a large fertility clinic.
Justification:
IVF is a costly treatment option for women, their partners, and the public. Therefore, new therapies that improve reproductive and health outcomes are highly desirable. Furthermore, the economic burden of IVF is directly related to the number of attempted cycles, and hence there is a growing interest in the use of adjuvant therapies to optimize pregnancy outcomes on a per cycle basis.
Acupuncture, both traditional and laser, has become a popular adjuvant therapy for women undergoing IVF treatment. Previous studies attempting to validate the effects of traditional acupuncture on IVF outcomes have demonstrated contradicting results. Importantly, none of the prior studies controlled for the effect of embryonic aneuploidy, which is a major contributor to implantation failure and early miscarriage. Further, there are very few studies assessing the effects of laser and traditional acupuncture on IVF outcomes and no studies to date that take into account embryo genetics.
Hence, the purpose of this study is to investigate the feasibility of a randomized clinical trial assessing the effects of laser and traditional acupuncture on IVF outcomes in women undergoing euploid embryo transfer after complete chromosomal screening, thereby controlling for a normal karyotype and allowing for a more meaningful analysis of the effect of laser and traditional acupuncture on IVF outcomes.
Objectives:
- To assess patient acceptance and clinical feasibility of a well-designed randomized clinical pilot study comparing the effects of a clinical-dose (8 total sessions) of laser and needle acupuncture on pregnancy outcomes in IVF.
- To generate preliminary results based on a feasible study design that may inform the implementation of a larger randomized clinical study in the future.
Research design:
One hundred patients undergoing IVF with preimplantation genetics screening will be randomized using a computer-generated block randomization method to either the laser and traditional acupuncture (n = 50) or standard-of-care (n = 50) arm. The laser acupuncture arm will be offered treatment 3 times a week starting from menses, plus an additional treatment before embryo transfer (ET). The goal is to have completed 7 treatments prior to ET, for a total of 8 treatments (last treatment done at Olive Centre right before ET). Patients in the standard-of-care arm will receive standard treatment. Physicians and nurses will be blinded to the groups assigned and will provide the same standard of care to both groups. Participants will be asked to complete a short survey following each laser acupuncture treatment.
Study procedure:
Participants in the laser and needle acupuncture arm will be offered treatment 2-4 times a week starting from menses, plus an additional treatment before ET. The goal is to have completed 7 treatments prior to ET, then one one on the day of ET (before and after transfer), for a total of 8 treatment sessions. Participants will be asked to complete a short survey following each laser and traditional acupuncture session.
Because the results of the preimplantation genetic screening (PGS) do not return with enough time for a fresh embryo transfer, all PGS embryos are transferred as part of a frozen ET. Unfortunately, there are no consensus protocols on the use of acupuncture in either frozen or fresh embryo IVF transfers. As such, we have used the expert opinions of several registered acupuncturists skilled in reproductive health to arrive at a consensus laser acupuncture protocol that is appropriate for a frozen-embryo transfer. Full details of the protocol are included in the Research Proposal.
Laser and traditional acupuncture will be performed by a certified acupuncturist skilled in reproductive health and experienced with use of laser and needle acupuncture in IVF. Physicians and nurses will be blinded to the groups assigned. The following certified acupuncturists will be performing the acupunctures:
Lorne Brown Ryan Funk Emilie Salomons Christina Ceconni Allison Locke Kathleen Lee Bronwyn Melville There are fewer variables with laser acupuncture than traditional acupuncture. The amount of energy and distance from each acupoint are the same, so there is less variation between providers. With traditional acupuncture, there is difference in needle depth of penetration, pressure, etc. Additionally, while it would be ideal for the same acupuncturist to provide all the treatment, this isn't feasible for the acupuncture clinic.
The reference arm will receive standard treatment.
The questionnaire surveys will be given to the patient participants after each laser acupuncture session if they are in the acupuncture group, and after their embryo transfer if they are from the standard care group. The study participants will be taken to a different room/office within the clinic to complete the surveys. To ensure blinding, the questionnaires will be provided by research staff not involved in the direct care of the patients. After completing the survey, the participant will place it in a sealed envelope.
This way, the participant responses are anonymized, with only the participant identification number on the forms, and no other patient-identifying information. The responses will not be made known to the physicians and nurses.
Statistical analysis:
Feasibility outcomes to be assessed include recruitment rate, refusal rate, retention rate, non-compliance rate, ability to maintain blindedness of healthcare staff, inclusion of all important data points, and determination of centre willingness and capacity.
Success of feasibility will be determined by the following criteria:
- At least 70% of all eligible participants choose to participate
- At least 90% retention of those that choose to participate
- At least 90% of all recruited participants complete six acupuncture sessions and the follow up survey
- At least 95% maintained blindedness of healthcare providers
- Conditions
- Infertility, Aneuploidy
- Being tested
- Laser and Traditional Acupuncture
- Keywords
- In-vitro fertilization, acupuncture, preimplantation genetic screening, pregnancy, laser, miscarriage
- Medical subject headings
- Infertility, Aneuploidy, Abortion, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser and Traditional AcupunctureProcedure or surgery
Acupuncture (traditional and laser) and photobiomodulation will be performed by a certified acupuncturist on-site with experience in reproductive health and the initial visit will include an assessment and traditional Chinese medicine (TCM) diagnosis.
| Study group | Role | What they receive |
|---|---|---|
| Standard Care Group | No intervention | Patients in the control arm will not undergo laser and acupuncture treatment. The treatment and control group will be compared to the baseline pregnancy rate of women meeting the same inclusion and exclusion criteria from the clinic through a chart review over the two years prior to initiation of the study. |
| Laser and Acupuncture Group | Experimental | The patients in the treatment arm will have 7 treatments before transfer (2-4 sessions a week), for the 3 weeks from starting estrace leading to the day before embryo transfer, then one (before and after transfer) on the day of transfer (total 8 sessions). Each treatment leading up to transfer day treatment consists of:
1. Traditional Acupuncture at points Sp9 to SP6 EA2Hz Milliamp (Pantheon device), ST-36 B, LI4 unilateral, LV3 unilateral and/or LU7 unilateral, K6 unilateral.
2. Bioflex Array (Photobiomodulation) - simultaneously array placements with each treatment over the sacrum (points BL-31, BL 32, BL 33 BL 34, DU2, DU3) and lower Abdomen above uterus (Ren 2 to Ren 6)
3. Laser acupuncture over ST-9, ST10, SJ 17, ST-11. Ren 3 and Ren 4. 6.75 J per point at ST 9, ST10 (over carotid) and SJ17 (vertebral artery).
On the day of FET on site at IVF clinic there will be a before and after traditional and laser acupuncture treatment. Receives: Procedure: Laser and Traditional Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Pregnancy Rate
Pregnancy beyond 10 weeks' gestation
Measured: From date of embryo transfer until the date of first documented pregnancy, whichever comes first, up to 12 months
Secondary outcomes (3)
Biochemical Pregnancy Rate
positive human chorionic gonadotropin (hCG) serum or urine test > or = 11 days after embryo transfer
Measured: From date of embryo transfer until the date of first documented biochemical pregnancy, whichever comes first, up to 12 months
Cumulative Pregnancy Rate
Presence of at least one intrauterine gestational sac or fetal heartbeat confirmed by ultrasound 4-6 weeks after embryo transfer
Measured: From date of embryo transfer until the date of first documented intrauterine pregnancy, whichever comes first, up to 12 months
Live Birth Rate
Baby born alive after 24 weeks gestation
Measured: From date of embryo transfer until the date of birth, whichever comes first, up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2019
- Study start15 Sep 2019 (estimated)
- Primary completion1 Nov 2019 (estimated)
- Study completion1 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gary Nakhuda, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03981120
- Sponsor's protocol ID
- Acupuncture and IVF
- Status last verified
- Sep 2019
- First submitted
- 30 May 2019
- Last updated
- 6 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified research data will be deposited into a publicly accessible database after publication. This data includes demographics, treatment protocols, pregnancy outcomes, and other research-related information. At no time will identifying information, such their names, birth dates or street addresses be included in such data.
Publications
Manheimer E. Selecting a control for in vitro fertilization and acupuncture randomized controlled trials (RCTs): how sham controls may unnecessarily complicate the RCT evidence base. Fertil Steril. 2011 Jun 30;95(8):2456-61. doi: 10.1016/j.fertnstert.2011.04.040. Epub 2011 May 13.
PubMed 21570069Zheng CH, Huang GY, Zhang MM, Wang W. Effects of acupuncture on pregnancy rates in women undergoing in vitro fertilization: a systematic review and meta-analysis. Fertil Steril. 2012 Mar;97(3):599-611. doi: 10.1016/j.fertnstert.2011.12.007. Epub 2012 Jan 11.
PubMed 22243605Zhang Y, Phy J, Scott-Johnson C, Garos S, Orlando J, Prien S, Huang JC. Effects of a Delphi consensus acupuncture treatment protocol on the levels of stress and vascular tone in women undergoing in-vitro fertilization: a randomized clinical trial protocol. BMC Complement Altern Med. 2017 Apr 4;17(1):197. doi: 10.1186/s12906-017-1693-4.
PubMed 28376836Shen C, Wu M, Shu D, Zhao X, Gao Y. The role of acupuncture in in vitro fertilization: a systematic review and meta-analysis. Gynecol Obstet Invest. 2015;79(1):1-12. doi: 10.1159/000362231. Epub 2014 May 16.
PubMed 24854767Qian Y, Xia XR, Ochin H, Huang C, Gao C, Gao L, Cui YG, Liu JY, Meng Y. Therapeutic effect of acupuncture on the outcomes of in vitro fertilization: a systematic review and meta-analysis. Arch Gynecol Obstet. 2017 Mar;295(3):543-558. doi: 10.1007/s00404-016-4255-y. Epub 2016 Dec 19.
PubMed 27995371Manheimer E, Zhang G, Udoff L, Haramati A, Langenberg P, Berman BM, Bouter LM. Effects of acupuncture on rates of pregnancy and live birth among women undergoing in vitro fertilisation: systematic review and meta-analysis. BMJ. 2008 Mar 8;336(7643):545-9. doi: 10.1136/bmj.39471.430451.BE. Epub 2008 Feb 7.
PubMed 18258932Cheong YC, Dix S, Hung Yu Ng E, Ledger WL, Farquhar C. Acupuncture and assisted reproductive technology. Cochrane Database Syst Rev. 2013 Jul 26;2013(7):CD006920. doi: 10.1002/14651858.CD006920.pub3.
PubMed 23888428El-Toukhy T, Khalaf Y. The impact of acupuncture on assisted reproductive technology outcome. Curr Opin Obstet Gynecol. 2009 Jun;21(3):240-6. doi: 10.1097/GCO.0b013e3283292491.
PubMed 19276803El-Toukhy T, Sunkara SK, Khairy M, Dyer R, Khalaf Y, Coomarasamy A. A systematic review and meta-analysis of acupuncture in in vitro fertilisation. BJOG. 2008 Sep;115(10):1203-13. doi: 10.1111/j.1471-0528.2008.01838.x. Epub 2008 Jul 23.
PubMed 18652588Manheimer E, van der Windt D, Cheng K, Stafford K, Liu J, Tierney J, Lao L, Berman BM, Langenberg P, Bouter LM. The effects of acupuncture on rates of clinical pregnancy among women undergoing in vitro fertilization: a systematic review and meta-analysis. Hum Reprod Update. 2013 Nov-Dec;19(6):696-713. doi: 10.1093/humupd/dmt026. Epub 2013 Jun 27.
PubMed 23814102Kung A, Munne S, Bankowski B, Coates A, Wells D. Validation of next-generation sequencing for comprehensive chromosome screening of embryos. Reprod Biomed Online. 2015 Dec;31(6):760-9. doi: 10.1016/j.rbmo.2015.09.002. Epub 2015 Sep 9.
PubMed 26520420Deng S, Zhao X, DU R, He SI, Wen Y, Huang L, Tian G, Zhang C, Meng Z, Shi X. Is acupuncture no more than a placebo? Extensive discussion required about possible bias. Exp Ther Med. 2015 Oct;10(4):1247-1252. doi: 10.3892/etm.2015.2653. Epub 2015 Jul 23.
PubMed 26622473Anderson B, Rosenthal L. Acupuncture and in vitro fertilization: critique of the evidence and application to clinical practice. Complement Ther Clin Pract. 2013 Feb;19(1):1-5. doi: 10.1016/j.ctcp.2012.11.002. Epub 2012 Dec 14.
PubMed 23337556Smith CA, Grant S, Lyttleton J, Cochrane S. Using a Delphi consensus process to develop an acupuncture treatment protocol by consensus for women undergoing Assisted Reproductive Technology (ART) treatment. BMC Complement Altern Med. 2012 Jul 7;12:88. doi: 10.1186/1472-6882-12-88.
PubMed 22769059Smith CA, de Lacey S, Chapman M, Ratcliffe J, Norman RJ, Johnson N, Sacks G, Lyttleton J, Boothroyd C. Acupuncture to improve live birth rates for women undergoing in vitro fertilization: a protocol for a randomized controlled trial. Trials. 2012 May 18;13:60. doi: 10.1186/1745-6215-13-60.
PubMed 22607192
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Acupuncture on in Vitro Fertilization Outcomes in Women Undergoing Euploid Embryo Transfer - A Pilot Study
- ClinicalTrials.gov ID
- NCT03981120
- Acronym / sponsor ID
- Acupuncture and IVF
- Conditions
- Infertility, Aneuploidy
- Keywords
- In-vitro fertilization, acupuncture, preimplantation genetic screening, pregnancy, laser, miscarriage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 15 Sep 2019 (estimated)
- Primary completion
- 1 Nov 2019 (estimated)
- Study completion
- 1 Jan 2020 (estimated)
- First posted
- 10 Jun 2019 (actual)
- 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.
While IVF offers an effective treatment for infertility, a significant proportion of IVF cycles still result in failed implantation and early miscarriage. As such, new therapies that improve pregnancy outcomes are highly desirable. Both traditional and laser acupuncture during the IVF cycle has become a popular option for women looking to improve their pregnancy rates. However, studies looking to understand the effects of acupuncture on IVF have demonstrated contradicting results. While some studies show an improvement in pregnancy rates in women undergoing IVF with traditional acupuncture treatment, other studies show no difference. Moreover, there are few studies exploring the role of laser and traditional acupuncture in IVF cycles and the studies done thus far have shown no change in pregnancy rates. However, there have been no studies to-date that have looked at women who are receiving IVF for embryos with normal genetics. This is important because embryos with abnormal genetics are a major reason for failed implantation and miscarriage, which can make the effects of acupuncture on pregnancy rates difficult to evaluate. This study is a pilot study looking to better understand the role of laser and traditional acupuncture as a supplemental treatment in women undergoing euploid (normal genetics) embryo transfer. This is the first study to include only genetically normal embryos, which may help to better understand the effects of laser and traditional acupuncture on IVF outcomes.
Detailed description
Purpose:
To assess the feasibility and preliminary outcomes of a single-blinded randomized clinical trial evaluating the effect of laser and traditional acupuncture during the IVF cycle on pregnancy outcomes in women undergoing euploid embryo transfer.
Hypothesis:
A single-blinded randomized clinical trial evaluating the effects and reproductive outcomes of laser and traditional acupuncture during the IVF cycle will be acceptable to patients and feasible for a large fertility clinic.
Justification:
IVF is a costly treatment option for women, their partners, and the public. Therefore, new therapies that improve reproductive and health outcomes are highly desirable. Furthermore, the economic burden of IVF is directly related to the number of attempted cycles, and hence there is a growing interest in the use of adjuvant therapies to optimize pregnancy outcomes on a per cycle basis.
Acupuncture, both traditional and laser, has become a popular adjuvant therapy for women undergoing IVF treatment. Previous studies attempting to validate the effects of traditional acupuncture on IVF outcomes have demonstrated contradicting results. Importantly, none of the prior studies controlled for the effect of embryonic aneuploidy, which is a major contributor to implantation failure and early miscarriage. Further, there are very few studies assessing the effects of laser and traditional acupuncture on IVF outcomes and no studies to date that take into account embryo genetics.
Hence, the purpose of this study is to investigate the feasibility of a randomized clinical trial assessing the effects of laser and traditional acupuncture on IVF outcomes in women undergoing euploid embryo transfer after complete chromosomal screening, thereby controlling for a normal karyotype and allowing for a more meaningful analysis of the effect of laser and traditional acupuncture on IVF outcomes.
Objectives:
- To assess patient acceptance and clinical feasibility of a well-designed randomized clinical pilot study comparing the effects of a clinical-dose (8 total sessions) of laser and needle acupuncture on pregnancy outcomes in IVF.
- To generate preliminary results based on a feasible study design that may inform the implementation of a larger randomized clinical study in the future.
Research design:
One hundred patients undergoing IVF with preimplantation genetics screening will be randomized using a computer-generated block randomization method to either the laser and traditional acupuncture (n = 50) or standard-of-care (n = 50) arm. The laser acupuncture arm will be offered treatment 3 times a week starting from menses, plus an additional treatment before embryo transfer (ET). The goal is to have completed 7 treatments prior to ET, for a total of 8 treatments (last treatment done at Olive Centre right before ET). Patients in the standard-of-care arm will receive standard treatment. Physicians and nurses will be blinded to the groups assigned and will provide the same standard of care to both groups. Participants will be asked to complete a short survey following each laser acupuncture treatment.
Study procedure:
Participants in the laser and needle acupuncture arm will be offered treatment 2-4 times a week starting from menses, plus an additional treatment before ET. The goal is to have completed 7 treatments prior to ET, then one one on the day of ET (before and after transfer), for a total of 8 treatment sessions. Participants will be asked to complete a short survey following each laser and traditional acupuncture session.
Because the results of the preimplantation genetic screening (PGS) do not return with enough time for a fresh embryo transfer, all PGS embryos are transferred as part of a frozen ET. Unfortunately, there are no consensus protocols on the use of acupuncture in either frozen or fresh embryo IVF transfers. As such, we have used the expert opinions of several registered acupuncturists skilled in reproductive health to arrive at a consensus laser acupuncture protocol that is appropriate for a frozen-embryo transfer. Full details of the protocol are included in the Research Proposal.
Laser and traditional acupuncture will be performed by a certified acupuncturist skilled in reproductive health and experienced with use of laser and needle acupuncture in IVF. Physicians and nurses will be blinded to the groups assigned. The following certified acupuncturists will be performing the acupunctures:
Lorne Brown Ryan Funk Emilie Salomons Christina Ceconni Allison Locke Kathleen Lee Bronwyn Melville There are fewer variables with laser acupuncture than traditional acupuncture. The amount of energy and distance from each acupoint are the same, so there is less variation between providers. With traditional acupuncture, there is difference in needle depth of penetration, pressure, etc. Additionally, while it would be ideal for the same acupuncturist to provide all the treatment, this isn't feasible for the acupuncture clinic.
The reference arm will receive standard treatment.
The questionnaire surveys will be given to the patient participants after each laser acupuncture session if they are in the acupuncture group, and after their embryo transfer if they are from the standard care group. The study participants will be taken to a different room/office within the clinic to complete the surveys. To ensure blinding, the questionnaires will be provided by research staff not involved in the direct care of the patients. After completing the survey, the participant will place it in a sealed envelope.
This way, the participant responses are anonymized, with only the participant identification number on the forms, and no other patient-identifying information. The responses will not be made known to the physicians and nurses.
Statistical analysis:
Feasibility outcomes to be assessed include recruitment rate, refusal rate, retention rate, non-compliance rate, ability to maintain blindedness of healthcare staff, inclusion of all important data points, and determination of centre willingness and capacity.
Success of feasibility will be determined by the following criteria:
- At least 70% of all eligible participants choose to participate
- At least 90% retention of those that choose to participate
- At least 90% of all recruited participants complete six acupuncture sessions and the follow up survey
- At least 95% maintained blindedness of healthcare providers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care Group | No intervention | –Patients in the control arm will not undergo laser and acupuncture treatment. The treatment and control group will be compared to the baseline pregnancy rate of women meeting the same inclusion and exclusion criteria from the clinic through a chart review over the two years prior to initiation of the study. |
| Laser and Acupuncture Group | Experimental | Procedure: Laser and Traditional AcupunctureThe patients in the treatment arm will have 7 treatments before transfer (2-4 sessions a week), for the 3 weeks from starting estrace leading to the day before embryo transfer, then one (before and after transfer) on the day of transfer (total 8 sessions). Each treatment leading up to transfer day treatment consists of: 1. Traditional Acupuncture at points Sp9 to SP6 EA2Hz Milliamp (Pantheon device), ST-36 B, LI4 unilateral, LV3 unilateral and/or LU7 unilateral, K6 unilateral. 2. Bioflex Array (Photobiomodulation) - simultaneously array placements with each treatment over the sacrum (points BL-31, BL 32, BL 33 BL 34, DU2, DU3) and lower Abdomen above uterus (Ren 2 to Ren 6) 3. Laser acupuncture over ST-9, ST10, SJ 17, ST-11. Ren 3 and Ren 4. 6.75 J per point at ST 9, ST10 (over carotid) and SJ17 (vertebral artery). On the day of FET on site at IVF clinic there will be a before and after traditional and laser acupuncture treatment. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- use of preimplantation genetic screening
- treatment with IVF/intracytoplasmatic sperm injection (ICSI)
- age <40
- BMI <35
Key exclusion criteria (4 listed)
- three or more prior failed IVF cycles with euploid embryo transfer
- known structural or anatomic causes of infertility
- male factor infertility
- patients already receiving concomitant treatment within the last 3 months (e.g. reflexology, acupuncture, herbal supplements, meditation).
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 |
|---|---|---|
| Laser and Traditional AcupunctureAcupuncture (traditional and laser) and photobiomodulation will be performed by a certified acupuncturist on-site with experience in reproductive health and the initial visit will include an assessment and traditional Chinese medicine (TCM) diagnosis. | Procedure or surgery | Laser and Acupuncture Group |
Primary outcome
Overall Pregnancy Rate
Time frame: From date of embryo transfer until the date of first documented pregnancy, whichever comes first, up to 12 months
Pregnancy beyond 10 weeks' gestation
3 secondary outcomes
Biochemical Pregnancy Rate
Time frame: From date of embryo transfer until the date of first documented biochemical pregnancy, whichever comes first, up to 12 months
Cumulative Pregnancy Rate
Time frame: From date of embryo transfer until the date of first documented intrauterine pregnancy, whichever comes first, up to 12 months
Live Birth Rate
Time frame: From date of embryo transfer until the date of birth, whichever comes first, up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
- Background: PubMed 21570069Manheimer E. Selecting a control for in vitro fertilization and acupuncture randomized controlled trials (RCTs): how sham controls may unnecessarily complicate the RCT evidence base. Fertil Steril. 2011 Jun 30;95(8):2456-61. doi: 10.1016/j.fertnstert.2011.04.040. Epub 2011 May 13.
- Background: PubMed 22243605Zheng CH, Huang GY, Zhang MM, Wang W. Effects of acupuncture on pregnancy rates in women undergoing in vitro fertilization: a systematic review and meta-analysis. Fertil Steril. 2012 Mar;97(3):599-611. doi: 10.1016/j.fertnstert.2011.12.007. Epub 2012 Jan 11.
- Background: PubMed 28376836Zhang Y, Phy J, Scott-Johnson C, Garos S, Orlando J, Prien S, Huang JC. Effects of a Delphi consensus acupuncture treatment protocol on the levels of stress and vascular tone in women undergoing in-vitro fertilization: a randomized clinical trial protocol. BMC Complement Altern Med. 2017 Apr 4;17(1):197. doi: 10.1186/s12906-017-1693-4.
- Background: PubMed 24854767Shen C, Wu M, Shu D, Zhao X, Gao Y. The role of acupuncture in in vitro fertilization: a systematic review and meta-analysis. Gynecol Obstet Invest. 2015;79(1):1-12. doi: 10.1159/000362231. Epub 2014 May 16.
- Background: PubMed 27995371Qian Y, Xia XR, Ochin H, Huang C, Gao C, Gao L, Cui YG, Liu JY, Meng Y. Therapeutic effect of acupuncture on the outcomes of in vitro fertilization: a systematic review and meta-analysis. Arch Gynecol Obstet. 2017 Mar;295(3):543-558. doi: 10.1007/s00404-016-4255-y. Epub 2016 Dec 19.
- Background: PubMed 18258932Manheimer E, Zhang G, Udoff L, Haramati A, Langenberg P, Berman BM, Bouter LM. Effects of acupuncture on rates of pregnancy and live birth among women undergoing in vitro fertilisation: systematic review and meta-analysis. BMJ. 2008 Mar 8;336(7643):545-9. doi: 10.1136/bmj.39471.430451.BE. Epub 2008 Feb 7.
- Background: PubMed 23888428Cheong YC, Dix S, Hung Yu Ng E, Ledger WL, Farquhar C. Acupuncture and assisted reproductive technology. Cochrane Database Syst Rev. 2013 Jul 26;2013(7):CD006920. doi: 10.1002/14651858.CD006920.pub3.
- Background: PubMed 19276803El-Toukhy T, Khalaf Y. The impact of acupuncture on assisted reproductive technology outcome. Curr Opin Obstet Gynecol. 2009 Jun;21(3):240-6. doi: 10.1097/GCO.0b013e3283292491.
- Background: PubMed 18652588El-Toukhy T, Sunkara SK, Khairy M, Dyer R, Khalaf Y, Coomarasamy A. A systematic review and meta-analysis of acupuncture in in vitro fertilisation. BJOG. 2008 Sep;115(10):1203-13. doi: 10.1111/j.1471-0528.2008.01838.x. Epub 2008 Jul 23.
- Background: PubMed 23814102Manheimer E, van der Windt D, Cheng K, Stafford K, Liu J, Tierney J, Lao L, Berman BM, Langenberg P, Bouter LM. The effects of acupuncture on rates of clinical pregnancy among women undergoing in vitro fertilization: a systematic review and meta-analysis. Hum Reprod Update. 2013 Nov-Dec;19(6):696-713. doi: 10.1093/humupd/dmt026. Epub 2013 Jun 27.
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- Individual participant dataSharing planned: Yes. The de-identified research data will be deposited into a publicly accessible database after publication. This data includes demographics, treatment protocols, pregnancy outcomes, and other research-related information. At no time will identifying information, such their names, birth dates or street addresses be included in such data.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Laser and Traditional Acupuncture in people with Infertility and Aneuploidy, run by University of British Columbia.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 6 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
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?
Overall Pregnancy Rate (time frame: From date of embryo transfer until the date of first documented pregnancy, whichever comes first, up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03981120, which also lists 19 linked publications.
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 6 Sep 2019.