PregnancyPhase 4AcuIVFNCT00722462
The Effect of Acupuncture on Pregnancy Rates in Women Undergoing Embryo Transfer
A Phase 4 study testing Active acupuncture in people with Pregnancy, run by Ottawa Fertility Centre at 1 site in Canada.
Trial summary
The present study is designed to test the hypothesis that acupuncture, before and after embryo transfer, significantly improves pregnancy rates, compared to embryo transfer with sham acupuncture and no acupuncture at all. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- Active acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2008to May 2009
- Phase
- Phase 4
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- patient is undergoing embryo transfer after IVF or ICSI
- patient has given informed consent to participate
Who cannot join
- frozen embryo transfer
- previous enrollment in study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Acupuncture on Pregnancy Rates in Women Undergoing Embryo Transfer After in Vitro Fertilization: A Prospective Randomized Sham-controlled Trial
The present study is designed to test the hypothesis that acupuncture, before and after embryo transfer, significantly improves pregnancy rates, compared to embryo transfer with sham acupuncture and no acupuncture at all.
- Conditions
- Pregnancy
- Being tested
- Active acupuncture, Sham acupuncture
- Keywords
- Infertility, IVF, Acupuncture
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active acupunctureProcedure or surgery
Acupuncture 25 minutes before and after embryo transfer
Sham acupunctureProcedure or surgery
Acupuncture at neutral points, 25 minutes before and after embryo transfer
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Active acupuncture Receives: Procedure: Active acupuncture |
| 2 | Sham comparator | Sham Acupuncture- acupuncture at neutral points Receives: Procedure: Sham acupuncture |
| 3 | No intervention | Embryo transfer with no acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Pregnancy
Measured: 4-5 weeks after treatment
Secondary outcomes (3)
Live birth
Measured: 9 months after treatment
Implantation rate
Measured: 4-5 weeks after treatment
Side effects with acupuncture treatment
Measured: 2 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2008 (estimated)
- Study startAug 2008
- Primary completionMay 2009
- Study completionMay 2009
Why it stopped: Recent abstract publication questioning the need for our study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Fertility Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arthur Leader, MD, Study chair, Ottawa Fertility CentreDoron Shmorgun, MD, Principal investigator, Ottawa Fertility Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00722462
- Sponsor's protocol ID
- OttawaFC
- Acronym
- AcuIVF
- Status last verified
- Jul 2015
- First submitted
- 23 Jul 2008
- Last updated
- 9 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Acupuncture on Pregnancy Rates in Women Undergoing Embryo Transfer After in Vitro Fertilization: A Prospective Randomized Sham-controlled Trial
- ClinicalTrials.gov ID
- NCT00722462
- Acronym / sponsor ID
- AcuIVF / OttawaFC
- Conditions
- Pregnancy
- Keywords
- Infertility, IVF, Acupuncture
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recent abstract publication questioning the need for our study
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ottawa Fertility CentreUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 25 Jul 2008 (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.
The present study is designed to test the hypothesis that acupuncture, before and after embryo transfer, significantly improves pregnancy rates, compared to embryo transfer with sham acupuncture and no acupuncture at all.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Active acupunctureActive acupuncture |
| 2 | Sham comparator | Procedure: Sham acupunctureSham Acupuncture- acupuncture at neutral points |
| 3 | No intervention | –Embryo transfer with no acupuncture |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- patient is undergoing embryo transfer after IVF or ICSI
- patient has given informed consent to participate
Key exclusion criteria (2 listed)
- frozen embryo transfer
- previous enrollment in study
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 |
|---|---|---|
| Active acupunctureAcupuncture 25 minutes before and after embryo transfer | Procedure or surgery | 1 |
| Sham acupunctureAcupuncture at neutral points, 25 minutes before and after embryo transfer | Procedure or surgery | 2 |
Primary outcome
Clinical Pregnancy
Time frame: 4-5 weeks after treatment
3 secondary outcomes
Live birth
Time frame: 9 months after treatment
Implantation rate
Time frame: 4-5 weeks after treatment
Side effects with acupuncture treatment
Time frame: 2 weeks after treatment
Results and safety
The study was stopped early (reason given: Recent abstract publication questioning the need for our study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2015.
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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.
Arthur Leader, MD study chair
Ottawa Fertility Centre
Doron Shmorgun, MD principal investigator
Ottawa Fertility Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Active acupuncture in people with Pregnancy, run by Ottawa Fertility Centre at 1 site in Canada.
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 2 inclusion and 2 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 Jul 2015. 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 Canada. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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: Recent abstract publication questioning the need for our study). 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 (time frame: 4-5 weeks after treatment). 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 Jul 2015.