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Sponsored by: |
Shaare Zedek Medical Center |
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Information provided by: | Shaare Zedek Medical Center |
ClinicalTrials.gov Identifier: | NCT00544401 |
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 | Intervention | Phase |
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Infertility |
Other: Hypnopuncture (Hypnosis+Acupuncture) |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | Effect of Hypnosis and Acupuncture (Hypnopuncture) on Pregnancy Rates Following Assisted Reproductive Treatment (IVF/ICSI): A Pilot Study |
Estimated Enrollment: | 100 |
Study Start Date: | November 2008 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Hypnopuncture Treatment
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Other: Hypnopuncture (Hypnosis+Acupuncture)
hypnosis and acupuncture
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2: No Intervention
Conventional IVF/ICSI treatment only
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Noah Samuels, MD | 972-2-6666395 | refplus@netvision.net.il |
Israel | |
Shaare Zedek Medical Center | Completed |
Jerusalem, Israel | |
Shaare Zedek Medical Center | Recruiting |
Jerusalem, Israel |
Principal Investigator: | Noah Samuels, MD | Center for Integrative Complementary Medicine, Shaare Zedek Medical Center, Jerusalem, Israel. |
Responsible Party: | Shaare Zedek Medical Center ( Dr. Noah Samuels ) |
Study ID Numbers: | HP.IVF.07 |
Study First Received: | October 15, 2007 |
Last Updated: | December 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00544401 History of Changes |
Health Authority: | Israel: Ministry of Health |
infertility in vitro fertilization intracytoplasmic sperm implantation |
acupuncture hypnosis hypnopuncture |
Genital Diseases, Female Infertility Genital Diseases, Male Spastic Paraplegia Epilepsy Mental Retardation |
Genital Diseases, Female Infertility Genital Diseases, Male |