Pain Clinical Trial
Official title:
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.
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).
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care
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