Acupuncture for Symptom Control During Assisted Reproductive Treatments Procedures

Effectiveness of Acupuncture Added to Standard Care Vs Standard Care Alone During In-Vitro-Fertilization: A Randomized Controlled Trial

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.

Study Overview

• Status: Unknown
• Conditions: Pain; Infertility
• Intervention / Treatment: Other: Acupuncture

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).

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Max Cohen, M.D; Phone Number: 972506268302; Email: medmax88@gmail.com
• Study Contact Backup: Name: Elad Schiff, M.D; Phone Number: 972506267243; Email: elad.schiff@b-zion.org.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 44 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Acupuncture treatment; 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.	Other: Acupuncture; Acupuncture
No Intervention: Control; Standard medical care during In-Vitro-Fertilization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Before and after acupuncture treatments prior to IVF 15 minutes before pickup and 15 minutes after pickup.
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.	Pain during pickup will be assessed 15 minutes after pickup.

Collaborators and Investigators

• Sponsor: Bnai Zion Medical Center
• Investigators: Study Chair: Ilan Calderon, MD, Deputy CEO, Bnai Zion Medical Center

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): May 1, 2017

Study Registration Dates

• First Submitted: November 2, 2015
• First Submitted That Met QC Criteria: November 20, 2015
• First Posted (Estimate): November 23, 2015

Study Record Updates

• Last Update Posted (Estimate): November 24, 2015
• Last Update Submitted That Met QC Criteria: November 22, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: BnaiZionIVF