The Effect of Acupuncture on in Vitro Fertilization Outcomes in Women Undergoing Euploid Embryo Transfer - A Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 100
- Primary Endpoint
- Overall Pregnancy Rate
Study Overview
Brief 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. 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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Care Provider, Investigator, Outcomes Assessor)
Masking Description
Participants will be assigned a computer generated code to be used on data collection forms.
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •use of preimplantation genetic screening
- •treatment with IVF/intracytoplasmatic sperm injection (ICSI)
Exclusion Criteria
- •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).
Arms & Interventions
Standard Care Group
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
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:
- Traditional Acupuncture at points Sp9 to SP6 EA2Hz Milliamp (Pantheon device), ST-36 B, LI4 unilateral, LV3 unilateral and/or LU7 unilateral, K6 unilateral.
- 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)
- 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.
Intervention: Laser and Traditional Acupuncture (Procedure)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Cumulative Pregnancy Rate(From date of embryo transfer until the date of first documented intrauterine pregnancy, whichever comes first, up to 12 months)
- Biochemical Pregnancy Rate(From date of embryo transfer until the date of first documented biochemical pregnancy, whichever comes first, up to 12 months)
- Live Birth Rate(From date of embryo transfer until the date of birth, whichever comes first, up to 12 months)
Investigators
Gary Nakhuda
Assistant Professor
University of British Columbia