InfertilityPhase 2/3NCT00544401
Hypnopuncture for In Vitro Fertilization (IVF)
A Phase 2/3 study testing Hypnopuncture (Hypnosis+Acupuncture) in people with Infertility, run by Shaare Zedek Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- Hypnopuncture (Hypnosis+Acupuncture)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2008to Aug 2010
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Hypnosis and Acupuncture (Hypnopuncture) on Pregnancy Rates Following Assisted Reproductive Treatment (IVF/ICSI): A Pilot Study
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.
- Conditions
- Infertility
- Being tested
- Hypnopuncture (Hypnosis+Acupuncture)
- Keywords
- infertility, in vitro fertilization, intracytoplasmic sperm implantation, acupuncture, hypnosis, hypnopuncture
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypnopuncture (Hypnosis+Acupuncture)Other
hypnosis and acupuncture
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Hypnopuncture Treatment Receives: Other: Hypnopuncture (Hypnosis+Acupuncture) |
| 2 | No intervention | Conventional IVF/ICSI treatment only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Pregnancy - at least one intrauterine gestational sac on ultrasound scan at 3 weeks following embryo transfer
Measured: 3 weeks
Secondary outcomes (4)
Implantation Rate - no. of gestational sacs/no. of transferred embryos (%)
Measured: 12 weeks
Ongoing pregnancy - viable intrauterine fetus at 12 weeks gestation
Measured: 12 weeks
Pregnancy rate following treatment of control group at 4th cycle
Measured: 12 weeks
Safety of hypnopuncture
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2007 (estimated)
- Study startNov 2008
- Primary completionAug 2010 (estimated)
Why it stopped: Lack of participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Noah Samuels, MD, Principal investigator, Center for Integrative Complementary Medicine, Shaare Zedek Medical Center, Jerusalem, Israel.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00544401
- Sponsor's protocol ID
- HP.IVF.07
- Status last verified
- Jun 2010
- First submitted
- 15 Oct 2007
- Last updated
- 9 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hypnosis and Acupuncture (Hypnopuncture) on Pregnancy Rates Following Assisted Reproductive Treatment (IVF/ICSI): A Pilot Study
- ClinicalTrials.gov ID
- NCT00544401
- Acronym / sponsor ID
- HP.IVF.07
- Conditions
- Infertility
- Keywords
- infertility, in vitro fertilization, intracytoplasmic sperm implantation, acupuncture, hypnosis, hypnopuncture
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of participants
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Aug 2010 (estimated)
- First posted
- 16 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Hypnopuncture (Hypnosis+Acupuncture)Hypnopuncture Treatment |
| 2 | No intervention | –Conventional IVF/ICSI treatment only |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypnopuncture (Hypnosis+Acupuncture)hypnosis and acupuncture | Other | 1 |
Primary outcome
Clinical Pregnancy - at least one intrauterine gestational sac on ultrasound scan at 3 weeks following embryo transfer
Time frame: 3 weeks
4 secondary outcomes
Implantation Rate - no. of gestational sacs/no. of transferred embryos (%)
Time frame: 12 weeks
Ongoing pregnancy - viable intrauterine fetus at 12 weeks gestation
Time frame: 12 weeks
Pregnancy rate following treatment of control group at 4th cycle
Time frame: 12 weeks
Safety of hypnopuncture
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: Lack of participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noah Samuels, MD principal investigator
Center for Integrative Complementary Medicine, Shaare Zedek Medical Center, Jerusalem, Israel.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Hypnopuncture (Hypnosis+Acupuncture) in people with Infertility, run by Shaare Zedek Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Lack of participants). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Pregnancy - at least one intrauterine gestational sac on ultrasound scan at 3 weeks following embryo transfer (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2010.