Hypnopuncture for In Vitro Fertilization (IVF)

This study has been terminated.
(Lack of participants)
Sponsor:
Information provided by:
Shaare Zedek Medical Center
ClinicalTrials.gov Identifier:
NCT00544401
First received: October 15, 2007
Last updated: June 8, 2010
Last verified: June 2010
  Purpose

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
Infertility
Other: Hypnopuncture (Hypnosis+Acupuncture)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Shaare Zedek Medical Center:

Primary Outcome Measures:
  • Clinical Pregnancy - at least one intrauterine gestational sac on ultrasound scan at 3 weeks following embryo transfer [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]

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

Enrollment: 6
Study Start Date: November 2008
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Hypnopuncture Treatment
Other: Hypnopuncture (Hypnosis+Acupuncture)
hypnosis and acupuncture
No Intervention: 2
Conventional IVF/ICSI treatment only

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00544401

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

No publications provided

Responsible Party: Dr. Noah Samuels, Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT00544401     History of Changes
Other Study ID Numbers: HP.IVF.07
Study First Received: October 15, 2007
Last Updated: June 8, 2010
Health Authority: Israel: Ministry of Health

Keywords provided by Shaare Zedek Medical Center:
infertility
in vitro fertilization
intracytoplasmic sperm implantation
acupuncture
hypnosis
hypnopuncture

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on October 01, 2014