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
About this trial
This is an interventional supportive care trial for Infertility
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.
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
NCT ID
NCT02611726
First Posted
November 2, 2015
Last Updated
November 22, 2015
Sponsor
Bnai Zion Medical Center
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
Learn more about this trial
Acupuncture for Symptom Control During Assisted Reproductive Treatments Procedures
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