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

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ClinicalTrials.gov Identifier: NCT03981120
Recruitment Status : Not yet recruiting
First Posted : June 10, 2019
Last Update Posted : June 11, 2019
Sponsor:
Information provided by (Responsible Party):
Gary Nakhuda, University of British Columbia

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 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 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 acupuncture on IVF outcomes.

Condition or disease Intervention/treatment Phase
Infertility Aneuploidy Procedure: Laser Acupuncture Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Masking Description: Participants will be assigned a computer generated code to be used on data collection forms.
Primary Purpose: Treatment
Official Title: The Effect of Acupuncture on in Vitro Fertilization Outcomes in Women Undergoing Euploid Embryo Transfer - A Pilot Study
Estimated Study Start Date : July 15, 2019
Estimated Primary Completion Date : November 1, 2019
Estimated Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture

Arm Intervention/treatment
No Intervention: Standard Care Group
Patients in the control arm will lie down in a relaxing environment for the same duration allotted to 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.
Experimental: Laser Acupuncture Group
The acupuncture arm will follow the Delphi consensus, which includes (1) a treatment session on day 6-8 of controlled ovarian hyperstimulation and will include core points ST29, CV4, CV6. SP6, SP10, +5 additional points to be individualized to each patient, (2) a second treatment before ET using points SP8, SP10, LR3, ST29, CV4 and one selected from HT7/PC6/YingTang depending on the individual patient, (3) a third treatment within 48 hours post-ET using points GV20, KD3, ST36. SP6, PC6 and auricular acupuncture points Shenmen and Zigong (only to be used on the day of ET).
Procedure: Laser Acupuncture
Acupuncture 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, in keeping with the semi-standardized Delphi consensus protocol.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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 ]
    positive human chorionic gonadotropin (hCG) serum or urine test > or = 11 days after embryo transfer

  2. 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 ]
    Presence of at least one intrauterine gestational sac or fetal heartbeat confirmed by ultrasound 4-6 weeks after embryo transfer

  3. Live Birth Rate [ Time Frame: From date of embryo transfer until the date of birth, whichever comes first, up to 12 months ]
    Baby born alive after 24 weeks gestation


Other Outcome Measures:
  1. Rate of miscarriage [ Time Frame: From date of embryo transfer until diagnosis, up to 12 months. ]
    Loss of pregnancy

  2. Rate of adverse events [ Time Frame: Any time during study period up to 12 months ]
    Any unfavourable outcome from medication or procedures.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

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 in the cycle (e.g. reflexology, acupuncture, herbal supplements, meditation).

Publications:

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Responsible Party: Gary Nakhuda, Assistant Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT03981120     History of Changes
Other Study ID Numbers: Acupuncture and IVF
First Posted: June 10, 2019    Key Record Dates
Last Update Posted: June 11, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Informed Consent Form (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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Gary Nakhuda, University of British Columbia:
In-vitro fertilization
acupuncture
preimplantation genetic screening
pregnancy
laser
miscarriage

Additional relevant MeSH terms:
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Infertility
Aneuploidy
Genital Diseases, Male
Genital Diseases, Female
Chromosome Aberrations
Pathologic Processes