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Acupuncture for Symptom Control During Assisted Reproductive Treatments Procedures

Primary Purpose

Infertility, Pain

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Acupuncture
Sponsored by
Bnai Zion Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Infertility

Eligibility Criteria

20 Years - 44 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Any patient who under going an IVF treatment in the investigators' unit.

Exclusion Criteria:

  • Patient who disagree to participate in the study,
  • Patient who are undergoing ovulation induction or AID.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    Acupuncture treatment

    Control

    Arm Description

    Individualized acupuncture needle insertion according to traditional Chinese and Japanese medicine on top of standard medical care during In-Vitro-Fertilization. Acupuncture needles will be inserted to body surface points following traditional diagnosis (anamnesis, tongue, pulse and abdomen inspection) according to practitioner discretion.

    Standard medical care during In-Vitro-Fertilization.

    Outcomes

    Primary Outcome Measures

    Anxiety before In-Vitro-Fertilization pickup assessed using Visual Analogue Scales (no anxiety 0-10 worst anxiety).
    Anxiety will be reported by patients on Visual Analogue Scales (VAS). Mean change in anxiety level will be compared between groups.
    Pain level during In-Vitro-Fertilization pickup assessed using Visual Analogue Scale (no pain 0-10 worst pain)
    Pain will be reported by patients on Visual Analogue Scales (VAS). Mean pain level will be compared between groups.

    Secondary Outcome Measures

    Full Information

    First Posted
    November 2, 2015
    Last Updated
    November 22, 2015
    Sponsor
    Bnai Zion Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02611726
    Brief Title
    Acupuncture for Symptom Control During Assisted Reproductive Treatments Procedures
    Official Title
    Effectiveness of Acupuncture Added to Standard Care Vs Standard Care Alone During In-Vitro-Fertilization: A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 2015 (undefined)
    Primary Completion Date
    December 2016 (Anticipated)
    Study Completion Date
    May 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Bnai Zion Medical Center

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Rationale for conducting the experiment: Israel performed IVF treatments since 1980. Although ART (Advanced Reproductive Treatments) have evolved over the years implantation and pregnancy rates have not met the expectations yet. Success rates of fertility treatments are about 15-18% (clinical pregnancy rates =CPR). As a result additional methods (clinical, technological and complimentary) have been tried to improve the CPR. In some reviews the effects of acupuncture practice during fertility treatments showed certain benefits, including pain relief and relaxation. Unfortunately those trials were not randomized and lacked methodological rigor. The aim of this study is to evaluate the effect of acupuncture on pain, anxiety, and CPR of women undergoing IVF as compared to standard care alone.
    Detailed Description
    Women planned for IVF at the investigators' institution will be offered to participate in this trial. Following consent, women will be randomized to acupuncture in addition to standard care OR standard care only according to the working days of the acupuncture practitioner (working alternately three days a week). After IVF stimulation protocol the patients in the acupuncture group will have three acupuncture treatments: The first will take place right after oocytes retrieval and the second treatment will be right before embryo transfer, and lastly 20-30 minutes after embryo transfer. Patients in the control group will receive standard care only. Patients in both groups will fill out questionnaires regarding expectations from complementary medicine (likert scale no expectation--high expectation), anxiety level (Visual Analogue Scale= VAS) before the procedures, as well as pain assessment (VAS) before and after the IVF procedures. In addition, a general satisfaction questionnaire from the overall care at the IVF unit will be completed at the last visit (likert scale very unsatisfied--highly satisfied). Finally, the physicians will report procedure ease or complexity on a likert scale (very easy-very difficult).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Infertility, Pain

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    400 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Acupuncture treatment
    Arm Type
    Active Comparator
    Arm Description
    Individualized acupuncture needle insertion according to traditional Chinese and Japanese medicine on top of standard medical care during In-Vitro-Fertilization. Acupuncture needles will be inserted to body surface points following traditional diagnosis (anamnesis, tongue, pulse and abdomen inspection) according to practitioner discretion.
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Standard medical care during In-Vitro-Fertilization.
    Intervention Type
    Other
    Intervention Name(s)
    Acupuncture
    Intervention Description
    Acupuncture
    Primary Outcome Measure Information:
    Title
    Anxiety before In-Vitro-Fertilization pickup assessed using Visual Analogue Scales (no anxiety 0-10 worst anxiety).
    Description
    Anxiety will be reported by patients on Visual Analogue Scales (VAS). Mean change in anxiety level will be compared between groups.
    Time Frame
    Before and after acupuncture treatments prior to IVF 15 minutes before pickup and 15 minutes after pickup.
    Title
    Pain level during In-Vitro-Fertilization pickup assessed using Visual Analogue Scale (no pain 0-10 worst pain)
    Description
    Pain will be reported by patients on Visual Analogue Scales (VAS). Mean pain level will be compared between groups.
    Time Frame
    Pain during pickup will be assessed 15 minutes after pickup.

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    44 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Any patient who under going an IVF treatment in the investigators' unit. Exclusion Criteria: Patient who disagree to participate in the study, Patient who are undergoing ovulation induction or AID.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Max Cohen, M.D
    Phone
    972506268302
    Email
    medmax88@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Elad Schiff, M.D
    Phone
    972506267243
    Email
    elad.schiff@b-zion.org.il
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ilan Calderon, MD
    Organizational Affiliation
    Deputy CEO, Bnai Zion Medical Center
    Official's Role
    Study Chair

    12. IPD Sharing Statement

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    Acupuncture for Symptom Control During Assisted Reproductive Treatments Procedures

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