The Effect of Acupuncture on Pregnancy Rates in Women Undergoing in Vitro Fertilization With Preimplantation Genetic Screening

NCT03981120 | Unknown

• 1 other identifier: Acupuncture and IVF
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Infertility; Aneuploidy

Keywords

In-vitro fertilization; acupuncture; preimplantation genetic screening; pregnancy; laser; miscarriage

Outcome Measures

Primary Outcomes (1)

• Overall Pregnancy Rate

  Pregnancy beyond 10 weeks' gestation

  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

  From date of embryo transfer until the date of first documented biochemical pregnancy, whichever comes first, up to 12 months

• Cumulative Pregnancy Rate

  From date of embryo transfer until the date of first documented intrauterine 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

Other Outcomes (2)

• Rate of miscarriage

  From date of embryo transfer until diagnosis, up to 12 months.

• Rate of adverse events

  Any time during study period up to 12 months

Study Arms (2)

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.

Procedure: Laser and Traditional Acupuncture

Interventions

Laser and Traditional Acupuncture PROCEDURE

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.

Laser and Acupuncture Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• use of preimplantation genetic screening
• treatment with IVF/intracytoplasmatic sperm injection (ICSI)
• age \<40
• BMI \<35

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of British Columbia: lead

Related Publications (19)

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MeSH Terms

Conditions

Infertility; Aneuploidy; Abortion, Spontaneous

Interventions

Lasers

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Chromosome Aberrations; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants will be assigned a computer generated code to be used on data collection forms.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 30, 2019
• First Posted: June 10, 2019
• Study Start: September 15, 2019
• Primary Completion: November 1, 2019
• Study Completion: January 1, 2020
• Last Updated: September 6, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will be available within 6 months after the completion of the study.
• Access Criteria: Data access requests will be reviewed by an external independent review panel. Requestors will need to sign a Data Access Agreement