Clinical trial NCT00544401: Hypnopuncture for In Vitro Fertilization (IVF)
Official title: Effect of Hypnosis and Acupuncture (Hypnopuncture) on Pregnancy Rates Following Assisted Reproductive Treatment (IVF/ICSI): A Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Infertility
Keywords: infertility
in vitro fertilization
intracytoplasmic sperm implantation
acupuncture
hypnosis
hypnopuncture
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
First posted: 2007-10-16
Enrollment: 6
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Females patients age 18 years and older
* Primary infertility with negative endocrinology and US findings on evaluation
* Following two failed cycles of either IVF or ICSI, defined as no clinical pregnancy (presence of fetal sac on ultrasound examination 6 weeks after embryo transfer).
* No underlying Axis 1 psychiatric disorder
* Ability to comply with study protocol

Exclusion Criteria:

* Patients displaying symptoms of overt Axis-1 psychopathology such as schizophrenia or severe depression.
* Current use of any CAM therapy
* Current use of any fertility treatment other than those prescribed by the fertility clinic.
* Inability to comply with the study protocol

Primary outcomes:
measure: Clinical Pregnancy - at least one intrauterine gestational sac on ultrasound scan at 3 weeks following embryo transfer
timeFrame: 3 weeks
Secondary outcomes:
measure: Implantation Rate - no. of gestational sacs/no. of transferred embryos (%)
timeFrame: 12 weeks
measure: Ongoing pregnancy - viable intrauterine fetus at 12 weeks gestation
timeFrame: 12 weeks
measure: Pregnancy rate following treatment of control group at 4th cycle
timeFrame: 12 weeks
measure: Safety of hypnopuncture
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
Study officials:
affiliation: Center for Integrative Complementary Medicine, Shaare Zedek Medical Center, Jerusalem, Israel.
name: Noah Samuels, MD
role: PRINCIPAL_INVESTIGATOR
References: