InfertilityNCT00913354
Acupuncture Versus Placebo Acupuncture During In Vitro Fertilization (IVF) Embryo Transfer
A study testing Acupuncture (Carbo®) in people with Infertility, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
During IVF treatment, acupuncture at the time of embryo transfer may improve the pregnancy rate. This study aims to compare IVF pregnancy between two groups of patients that received either acupuncture or sham acupuncture (placebo)around embryo transfer Read more about this study
- Who is it for?
- Ages 18 to 37 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Acupuncture (Carbo®)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 635 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2005to Mar 2009
- Phase
- Interventional
- 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 to 37 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- infertility
- below 38 years
- ivf or icsi treatment
- fresh embryo transfer cycle
- no more than two earlier embryo transfers with "fresh" embryos
- embryo transfer on day 2 or 3 after oocyte aspiration, single or double embryo transfer
Who cannot join
- Frozen embryo transfer
- oocyte donation
- other "alternative" treatment during the cycle
Trial locations and contacts
1 site in 1 country.
Denmark1 site
The Fertility Clinic, Copenhagen University Hospital, Denmark
Copenhagen, 2100
About this study
Official title: Acupuncture Versus Placebo Acupuncture During Ivf Embryo Transfer
During IVF treatment, acupuncture at the time of embryo transfer may improve the pregnancy rate. This study aims to compare IVF pregnancy between two groups of patients that received either acupuncture or sham acupuncture (placebo)around embryo transfer
Read the detailed description
Acupuncture at the time of embryo transfer may improve the IVF pregnancy rate. This study aims to compare the IVF pregnancy between two groups of patients that undergo ivf/icsi treatment. The patients are randomized to receive either acupuncture or sham acupuncture (placebo)around embryo transfer
- Conditions
- Infertility
- Being tested
- Acupuncture (Carbo®), Placebo acupuncture (Strietberger®)
- Keywords
- infertility, ivf, acupuncture
- Medical subject headings
- Infertility, Long Qt Syndrome 3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupuncture (Carbo®)Device
Also called Acupuncture needles: Carbo® needle,Acupharma A/S.
The acupuncture points were chosen according to traditional Chinese medicine and included DU20, M29, KS6, Mp8, and Le3 before embryo transfer and DU20, Co4, Mp10, M36, and Mp6 after embryo transfer.
Placebo acupuncture (Strietberger®)Device
Also called Sham acupuncture needles: Strietberger® placebo-needle, Asia Med.
The acupuncture points were the same as in the true acupuncture group, namely DU20, M29, KS6, Mp8, and Le3 before embryo transfer and DU20, Co4, Mp10, M36, and Mp6 after embryo transfer.
Sham acupuncture needles used were the validated Strietberger® placebo-needle from the company, Asia Med. The needle is not fixed inside the copper handle and its tip is blunt. When the needle touches the skin it moves inside the handle and appears to be shortened. A pricking sensation is felt by the patient, simulating the puncturing of the skin. Developed by dr. Konrad Streitberger.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 30 minutes of acupuncture just before and just after embryo replacement Receives: Device: Acupuncture (Carbo®) |
| 2 | Placebo comparator | Sham acupuncture for 30 minutes just before and just after embryo transfer Receives: Device: Placebo acupuncture (Strietberger®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate
Measured: 2005-2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2009 (estimated)
- Study startNov 2005
- Primary completionMar 2007
- Study completionMar 2009
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.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 635 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Investigators
- Dorthe Andersen, Study nurse, Principal investigator, The Fertility Clinic, Copenhagen University Hospital Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00913354
- Sponsor's protocol ID
- Acupuncture001
- Status last verified
- Nov 2005
- First submitted
- 3 Jun 2009
- Last updated
- 4 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture Versus Placebo Acupuncture During Ivf Embryo Transfer
- ClinicalTrials.gov ID
- NCT00913354
- Acronym / sponsor ID
- Acupuncture001
- Conditions
- Infertility
- Keywords
- infertility, ivf, acupuncture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 635 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Nov 2005
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 4 Jun 2009 (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.
During IVF treatment, acupuncture at the time of embryo transfer may improve the pregnancy rate. This study aims to compare IVF pregnancy between two groups of patients that received either acupuncture or sham acupuncture (placebo)around embryo transfer
Detailed description
Acupuncture at the time of embryo transfer may improve the IVF pregnancy rate. This study aims to compare the IVF pregnancy between two groups of patients that undergo ivf/icsi treatment. The patients are randomized to receive either acupuncture or sham acupuncture (placebo)around embryo transfer
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Acupuncture (Carbo®)30 minutes of acupuncture just before and just after embryo replacement |
| 2 | Placebo comparator | Device: Placebo acupuncture (Strietberger®)Sham acupuncture for 30 minutes just before and just after embryo transfer |
Who may qualify
- Ages
- 18 to 37 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- infertility
- below 38 years
- ivf or icsi treatment
- fresh embryo transfer cycle
- no more than two earlier embryo transfers with "fresh" embryos
Key exclusion criteria (3 listed)
- Frozen embryo transfer
- oocyte donation
- other "alternative" treatment during the cycle
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 |
|---|---|---|
| Acupuncture (Carbo®)Also: Acupuncture needles: Carbo® needle,Acupharma A/S.The acupuncture points were chosen according to traditional Chinese medicine and included DU20, M29, KS6, Mp8, and Le3 before embryo transfer and DU20, Co4, Mp10, M36, and Mp6 after embryo transfer. | Device | 1 |
| Placebo acupuncture (Strietberger®)Also: Sham acupuncture needles: Strietberger® placebo-needle, Asia Med.The acupuncture points were the same as in the true acupuncture group, namely DU20, M29, KS6, Mp8, and Le3 before embryo transfer and DU20, Co4, Mp10, M36, and Mp6 after embryo transfer. Sham acupuncture needles used were the validated Strietberger® placebo-needle from the company, Asia Med. The needle is not fixed inside the copper handle and its tip is blunt. When the needle touches the skin it moves inside the handle and appears to be shortened. A pricking sensation is felt by the patient, simulating the puncturing of the skin. Developed by dr. Konrad Streitberger. | Device | 2 |
Primary outcome
Clinical pregnancy rate
Time frame: 2005-2008
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2009.
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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.
Dorthe Andersen, Study nurse principal investigator
The Fertility Clinic, Copenhagen University Hospital Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture (Carbo®) in people with Infertility, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 6 inclusion and 3 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: finished, as of the sponsor's last update on 4 Jun 2009. 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 Denmark. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 rate (time frame: 2005-2008). 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 4 Jun 2009.