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Hypnopuncture for In Vitro Fertilization (IVF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00544401
Recruitment Status : Terminated (Lack of participants)
First Posted : October 16, 2007
Last Update Posted : June 9, 2010
Information provided by:
Shaare Zedek Medical Center

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.

Condition or disease Intervention/treatment Phase
Infertility Other: Hypnopuncture (Hypnosis+Acupuncture) Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Hypnosis and Acupuncture (Hypnopuncture) on Pregnancy Rates Following Assisted Reproductive Treatment (IVF/ICSI): A Pilot Study
Study Start Date : November 2008
Estimated Primary Completion Date : August 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Hypnopuncture Treatment
Other: Hypnopuncture (Hypnosis+Acupuncture)
hypnosis and acupuncture

No Intervention: 2
Conventional IVF/ICSI treatment only

Primary Outcome Measures :
  1. Clinical Pregnancy - at least one intrauterine gestational sac on ultrasound scan at 3 weeks following embryo transfer [ Time Frame: 3 weeks ]

Secondary Outcome Measures :
  1. Implantation Rate - no. of gestational sacs/no. of transferred embryos (%) [ Time Frame: 12 weeks ]
  2. Ongoing pregnancy - viable intrauterine fetus at 12 weeks gestation [ Time Frame: 12 weeks ]
  3. Pregnancy rate following treatment of control group at 4th cycle [ Time Frame: 12 weeks ]
  4. Safety of hypnopuncture [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00544401

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Shaare Zedek Medical Center
Jerusalem, Israel
Sponsors and Collaborators
Shaare Zedek Medical Center
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Principal Investigator: Noah Samuels, MD Center for Integrative Complementary Medicine, Shaare Zedek Medical Center, Jerusalem, Israel.

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Responsible Party: Dr. Noah Samuels, Shaare Zedek Medical Center Identifier: NCT00544401    
Other Study ID Numbers: HP.IVF.07
First Posted: October 16, 2007    Key Record Dates
Last Update Posted: June 9, 2010
Last Verified: June 2010
Keywords provided by Shaare Zedek Medical Center:
in vitro fertilization
intracytoplasmic sperm implantation
Additional relevant MeSH terms:
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Genital Diseases, Male
Genital Diseases, Female