Clinical trial NCT02611726: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Infertility
Pain
Lead sponsor: Bnai Zion Medical Center
Sponsor class: OTHER_GOV
First posted: 2015-11-23
Enrollment: 400
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).

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.

Primary outcomes:
measure: Anxiety before In-Vitro-Fertilization pickup assessed using Visual Analogue Scales (no anxiety 0-10 worst anxiety).
timeFrame: Before and after acupuncture treatments prior to IVF 15 minutes before pickup and 15 minutes after pickup.
measure: Pain level during In-Vitro-Fertilization pickup assessed using Visual Analogue Scale (no pain 0-10 worst pain)
timeFrame: Pain during pickup will be assessed 15 minutes after pickup.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Deputy CEO, Bnai Zion Medical Center
name: Ilan Calderon, MD
role: STUDY_CHAIR
References: