Polycystic Ovary SyndromeNCT00602940
Acupuncture for Polycystic Ovarian Syndrome
A study testing Acupuncture in people with Polycystic Ovary Syndrome, run by University of Virginia at 1 site in United States.
Trial summary
This is a randomized control trial of acupuncture for women with polycystic ovary syndrome. The study is triple-blinded. Read more about this study
- Who is it for?
- Ages 18 to 43 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Dec 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 18 to 43 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- ages 18-43
- confirmation of PCOS through the study
- signed informed consent
- able to receive study treatment at Virginia study sites
- agree not to use hormonal medications for the 5 months of the study
Who cannot join
- pregnant
- use of hormonal drugs 30/60 days before the study entry
- acupuncture for ovulatory disorders 30 days prior to study entry
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22908
About this study
Official title: The Influence of Acupuncture on Ovulation and Reproductive Hormones
This is a randomized control trial of acupuncture for women with polycystic ovary syndrome. The study is triple-blinded.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Acupuncture, Sham Acupuncture
- Keywords
- PCOS, ovulation, hormones, women
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
12 treatments over 8 weeks
Sham AcupunctureProcedure or surgery
12 treatments over 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Active acupuncture treatment Receives: Procedure: Acupuncture |
| 2 | Sham comparator | Sham acupuncture treatment Receives: Procedure: Sham Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
ovulation in 2 out of 5 months of study participation
Measured: monthly
Secondary outcomes (1)
changes in follicle stimulating hormone and luteinizing hormone
Measured: baseline vs. 2 months vs. 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2008 (estimated)
- Study startJan 2006
- Primary completionDec 2009 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Investigators
- Lisa M Pastore, PhD, Principal investigator, UVA OB/GYN Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00602940
- Sponsor's protocol ID
- 12045
- Other IDs
- NIH R21 AT002520
- Status last verified
- May 2010
- First submitted
- 15 Jan 2008
- Last updated
- 21 May 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Pastore LM, Patrie JT, Morris WL, Dalal P, Bray MJ. Depression symptoms and body dissatisfaction association among polycystic ovary syndrome women. J Psychosom Res. 2011 Oct;71(4):270-6. doi: 10.1016/j.jpsychores.2011.02.005. Epub 2011 Mar 23.
PubMed 21911106
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Acupuncture on Ovulation and Reproductive Hormones
- ClinicalTrials.gov ID
- NCT00602940
- Acronym / sponsor ID
- 12045
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- PCOS, ovulation, hormones, women
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 28 Jan 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.
This is a randomized control trial of acupuncture for women with polycystic ovary syndrome. The study is triple-blinded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: AcupunctureActive acupuncture treatment |
| 2 | Sham comparator | Procedure: Sham AcupunctureSham acupuncture treatment |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- ages 18-43
- confirmation of PCOS through the study
- signed informed consent
- able to receive study treatment at Virginia study sites
- agree not to use hormonal medications for the 5 months of the study
Key exclusion criteria (3 listed)
- pregnant
- use of hormonal drugs 30/60 days before the study entry
- acupuncture for ovulatory disorders 30 days prior to study entry
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 |
|---|---|---|
| Acupuncture12 treatments over 8 weeks | Procedure or surgery | 1 |
| Sham Acupuncture12 treatments over 8 weeks | Procedure or surgery | 2 |
Primary outcome
ovulation in 2 out of 5 months of study participation
Time frame: monthly
1 secondary outcome
changes in follicle stimulating hormone and luteinizing hormone
Time frame: baseline vs. 2 months vs. 5 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2010.
- Derived from this study: PubMed 21911106Pastore LM, Patrie JT, Morris WL, Dalal P, Bray MJ. Depression symptoms and body dissatisfaction association among polycystic ovary syndrome women. J Psychosom Res. 2011 Oct;71(4):270-6. doi: 10.1016/j.jpsychores.2011.02.005. Epub 2011 Mar 23.
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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.
Lisa M Pastore, PhD principal investigator
UVA OB/GYN Department
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 in people with Polycystic Ovary Syndrome, run by University of Virginia 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 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: status not confirmed, as of the sponsor's last update on 21 May 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 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. 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?
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?
ovulation in 2 out of 5 months of study participation (time frame: monthly). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00602940, which also lists 1 linked publication.
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 21 May 2010.