Hypnopuncture for In Vitro Fertilization (IVF)
Primary Purpose
Infertility
Status
Terminated
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
Hypnopuncture (Hypnosis+Acupuncture)
Sponsored by
About this trial
This is an interventional treatment trial for Infertility focused on measuring infertility, in vitro fertilization, intracytoplasmic sperm implantation, acupuncture, hypnosis, hypnopuncture
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
Sites / Locations
- Shaare Zedek Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
1
2
Arm Description
Hypnopuncture Treatment
Conventional IVF/ICSI treatment only
Outcomes
Primary Outcome Measures
Clinical Pregnancy - at least one intrauterine gestational sac on ultrasound scan at 3 weeks following embryo transfer
Secondary Outcome Measures
Implantation Rate - no. of gestational sacs/no. of transferred embryos (%)
Ongoing pregnancy - viable intrauterine fetus at 12 weeks gestation
Pregnancy rate following treatment of control group at 4th cycle
Safety of hypnopuncture
Full Information
NCT ID
NCT00544401
First Posted
October 15, 2007
Last Updated
June 8, 2010
Sponsor
Shaare Zedek Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00544401
Brief Title
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
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Terminated
Why Stopped
Lack of participants
Study Start Date
November 2008 (undefined)
Primary Completion Date
August 2010 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Shaare Zedek Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
infertility, in vitro fertilization, intracytoplasmic sperm implantation, acupuncture, hypnosis, hypnopuncture
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Hypnopuncture Treatment
Arm Title
2
Arm Type
No Intervention
Arm Description
Conventional IVF/ICSI treatment only
Intervention Type
Other
Intervention Name(s)
Hypnopuncture (Hypnosis+Acupuncture)
Intervention Description
hypnosis and acupuncture
Primary Outcome Measure Information:
Title
Clinical Pregnancy - at least one intrauterine gestational sac on ultrasound scan at 3 weeks following embryo transfer
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Implantation Rate - no. of gestational sacs/no. of transferred embryos (%)
Time Frame
12 weeks
Title
Ongoing pregnancy - viable intrauterine fetus at 12 weeks gestation
Time Frame
12 weeks
Title
Pregnancy rate following treatment of control group at 4th cycle
Time Frame
12 weeks
Title
Safety of hypnopuncture
Time Frame
12 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Noah Samuels, MD
Organizational Affiliation
Center for Integrative Complementary Medicine, Shaare Zedek Medical Center, Jerusalem, Israel.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
Country
Israel
12. IPD Sharing Statement
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Hypnopuncture for In Vitro Fertilization (IVF)
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