Infertility Clinical Trial
Official title:
Effect of Hypnosis and Acupuncture (Hypnopuncture) on Pregnancy Rates Following Assisted Reproductive Treatment (IVF/ICSI): A Pilot Study
Infertility is a common and distressful problem for many couples, with assisted reproductive
techniques (ART) such as IVF and ICSI, with slightly more than 34% pregnancies per cycle.
Acupuncture is an ancient Chinese treatment in which thin needles are inserted into various
points along the skin, harmonizing" the body's "energy. Acupuncture has been found to
increase pregnancy rates following IVF/ICSI treatments, and is believed to affect ovulation
and fertility through elevation of beta-endorphin release and GnRH secretion, as well as
reduced sympathetic response with increased blood flow to the uterus. The
sympatho-inhibitory properties and impact on beta-endorphin levels of acupuncture, as well
as its efficacy in treating depression, may be helpful in reducing stress among women
undergoing fertility treatments as well. Hypnosis is a mind-body technique which uses
suggestions during a relaxed state to promote healing. Hypnosis can also significantly
reduce the sympathetic response, and is believed to produce uterine relaxation and
quiescence during embryo transfer (ET), which may lead to a reduction in embryo displacement
from the uterine cavity. No research has been published on the use of hypnosis with
acupuncture (hypnopuncture) in ART.
This is a pilot study to evaluate the effect of a combined regimen of hypnopuncture on
clinical pregnancy rates in women undergoing IVF/ICSI following two failed cycles. During
the initial pre-treatment meeting, participants who fulfill all inclusion criteria and none
of the exclusion criteria will undergo hypnotic induction, followed by suggestions for
increased uterine blood flow. On the day of embryo transfer, participants will be randomly
divided into either treatment or no-treatment groups. Treatment will consist of the
insertion of acupuncture needles into pre-determined points, to be followed by a hypnosis
pre-recorded hypnosis session, as described above. Patients in the control group will
receive standard care without hypnopuncture and those participants in this group who do not
conceive following the 3rd cycle will be treated with hypnopuncture during the 4th cycle,
following ET. A total of 100 women will be enrolled, 50 in each arm of the study.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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