InfertilityNCT00736411
In Vitro Fertilization (IVF) and Acupuncture for Infertility
A study testing acupuncture and IVF in people with Infertility, run by Pacific Fertility Center at 1 site in United States.
Trial summary
The aim of this investigation is to determine the value of combining acupuncture with infertility patients undergoing In Vitro Fertilization (IVF). The investigators will measure the outcomes of endometrial lining, uterine blood flow, hormones, stress levels, and pregnancy and live birth rates. Read more about this study
- Who is it for?
- Ages 21 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- acupuncture and IVF
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Oct 2010
- 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 21 to 42 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- females between 21 and 42 years old
- primary or secondary infertility
- no more than 2 previously failed IVF cycles
- undergoing IVF
- FSH < 11
Who cannot join
- FSH > 11
- using an egg donor
- using PGD
- using heparin or lovanox protocols
- estradiol level less than 20 or over 80
- taking herbal therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Pacific Fertility Center
San Francisco, California, 94133
About this study
Official title: IVF and Acupuncture for Infertility: A Randomized Controlled Trail
The aim of this investigation is to determine the value of combining acupuncture with infertility patients undergoing In Vitro Fertilization (IVF). The investigators will measure the outcomes of endometrial lining, uterine blood flow, hormones, stress levels, and pregnancy and live birth rates.
- Conditions
- Infertility
- Being tested
- acupuncture, IVF
- 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.
acupunctureProcedure or surgery
16 treatments over 8 weeks
IVFProcedure or surgery
one 4 week IVF cycle
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | IVF Receives: Procedure: IVF |
| II | Other | treatment Receives: Procedure: acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
pregnancy
Measured: week 10 of study
Secondary outcomes (1)
uterine blood flow
Measured: final measurement in week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionOct 2010
- Study completionOct 2010
Why it stopped: Adjustments to ensure clear outcomes and scientific merit integrated. Study closed at 14 subjects. New protocol submitted to IRB.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pacific Fertility Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Caylie J See, L.Ac., Study director, Pacific Fertility Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00736411
- Sponsor's protocol ID
- 28.005-2
- Status last verified
- Oct 2015
- First submitted
- 13 Aug 2008
- Last updated
- 29 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IVF and Acupuncture for Infertility: A Randomized Controlled Trail
- ClinicalTrials.gov ID
- NCT00736411
- Acronym / sponsor ID
- 28.005-2
- Conditions
- Infertility
- Keywords
- infertility, IVF, acupuncture
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Adjustments to ensure clear outcomes and scientific merit integrated. Study closed at 14 subjects. New protocol submitted to IRB.
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Pacific Fertility CenterUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 15 Aug 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 aim of this investigation is to determine the value of combining acupuncture with infertility patients undergoing In Vitro Fertilization (IVF). The investigators will measure the outcomes of endometrial lining, uterine blood flow, hormones, stress levels, and pregnancy and live birth rates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: IVFIVF |
| II | Other | Procedure: acupuncturetreatment |
Who may qualify
- Ages
- 21 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- females between 21 and 42 years old
- primary or secondary infertility
- no more than 2 previously failed IVF cycles
- undergoing IVF
- FSH < 11
Key exclusion criteria (6 listed)
- FSH > 11
- using an egg donor
- using PGD
- using heparin or lovanox protocols
- estradiol level less than 20 or over 80
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 |
|---|---|---|
| acupuncture16 treatments over 8 weeks | Procedure or surgery | II |
| IVFone 4 week IVF cycle | Procedure or surgery | 1 |
Primary outcome
pregnancy
Time frame: week 10 of study
1 secondary outcome
uterine blood flow
Time frame: final measurement in week 8
Results and safety
The study was stopped early (reason given: Adjustments to ensure clear outcomes and scientific merit integrated. Study closed at 14 subjects. New protocol submitted to IRB.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 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.
Caylie J See, L.Ac. study director
Pacific Fertility Center
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 and IVF in people with Infertility, run by Pacific Fertility Center at 1 site in United States.
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 6 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 29 Oct 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 United States. 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.
Are results available for this study?
The study was stopped early (reason given: Adjustments to ensure clear outcomes and scientific merit integrated. Study closed at 14 subjects. New protocol submitted to IRB.). 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?
pregnancy (time frame: week 10 of study). 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 29 Oct 2015.