Polycystic Ovary SyndromePCOSLFEANCT00921492
Acupuncture and Gonadotropin-releasing Hormone Pulse Generator and Stress Axis in Polycystic Ovary Syndrome
A study testing Low-frequency electro-acupuncture (EA) in people with Polycystic Ovary Syndrome, run by Göteborg University at 1 site in Sweden.
Trial summary
Hypothesis The overall hypothesis is that non-obese (BMI <30) women with PCOS have high luteinising hormone (LH) and cortisol pulse frequency and amplitude and that repeated low-frequency EA restore these alterations and induce ovulation. Read more about this study
- Who is it for?
- Ages 18 to 39 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Low-frequency electro-acupuncture (EA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteSweden
- Study dates
- Feb 2009to 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 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 18 - 39 years, inclusive
- 30 ≤ BMI
- History of irregular menstrual cycles
- Clinical and/or biochemical androgen excess (determined during screening)
Who cannot join
- Medical Exclusion Criteria
- History or clinical manifestation of; cardiovascular disease, diabetes (Type 1 or Type 2), any other significant endocrine or metabolic disorder.
- Regular use of medications for weight control, psychosis and thyroid disease. A 3 month washout period will be permitted for contraceptives.
- Psychiatric and Behavioral Exclusion Criteria
- Pregnant or breast-feeding women
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Institute of Neuroscience and Physiology, Sahlgrenska Academy, Göteborg University
Gothenburg, 40530
About this study
Official title: Does Low-frequency Electro-acupuncture Restore Sensitivity of the Gonadotropin-releasing Hormone Pulse Generator and Stress Axis in Polycystic Ovary Syndrome
Hypothesis The overall hypothesis is that non-obese (BMI <30) women with PCOS have high luteinising hormone (LH) and cortisol pulse frequency and amplitude and that repeated low-frequency EA restore these alterations and induce ovulation.
Read the detailed description
Aim 1. Elucidate if low-frequency EA induce ovulation and restore LH frequency and amplitude as well as sex steroid secretion as compared to a control group receiving same amount of attention.
Aim 2. Elucidate if low-frequency EA restore cortisol frequency and amplitude compared to a control group receiving same amount of attention.
Aim 3. Elucidate if low-frequency EA restore psychological distress and quality of life as compared to a control group receiving same amount of attention.in women with PCOS.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Low-frequency electro-acupuncture (EA), Meeting a therapist - attention control
- Keywords
- Luteinizing hormone, Cortisol, HPA axis, HPO axis, Ovulation, Heart rate variability, Psychological distress and quality of life
- 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.
Low-frequency electro-acupuncture (EA)Device
2 Hz EA during 30 minutes, twice a week, 14 weeks.
Meeting a therapist - attention controlOther
Meeting a therapist, twice a week during 30 minutes in order to control for the increased amount of attention.
| Study group | Role | What they receive |
|---|---|---|
| Low-frequency electro-acupuncture | Experimental | Not described Receives: Device: Low-frequency electro-acupuncture (EA) |
| Meeting a therapist - attention | Active comparator | Not described Receives: Other: Meeting a therapist - attention control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequent blood sampling every 10th minute during an overnight stay in order to measure changes in LH and cortisol pulsatility before and after treatment. A third assessment will be made in those participants who ovulate during the 14 week study.
Measured: 16 weeks
Secondary outcomes (1)
Ovulation, health related quality of life
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2009 (estimated)
- Study startFeb 2009
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 Göteborg UniversityThe 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
- Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00921492
- Sponsor's protocol ID
- PCOSLFEA-17611
- Other IDs
- 2008-72VP-15445-01A, ALFFGBG-10984
- Acronym
- PCOSLFEA
- Status last verified
- Aug 2018
- First submitted
- 12 Jun 2009
- Last updated
- 15 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Samad M, Ek J, Kataoka J, Lindgren E, Ohlsson C, Wernstedt Asterholm I, Stener-Victorin E, Benrick A. Hypoadiponectinemia does not enhance anxiety-like behaviour in a lean PCOS-like mouse model. Sci Rep. 2026 Sep 3;16(1):27688. doi: 10.1038/s41598-026-69143-9.
PubMed 42693220Johansson J, Redman L, Veldhuis PP, Sazonova A, Labrie F, Holm G, Johannsson G, Stener-Victorin E. Acupuncture for ovulation induction in polycystic ovary syndrome: a randomized controlled trial. Am J Physiol Endocrinol Metab. 2013 May 1;304(9):E934-43. doi: 10.1152/ajpendo.00039.2013. Epub 2013 Mar 12.
PubMed 23482444
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Low-frequency Electro-acupuncture Restore Sensitivity of the Gonadotropin-releasing Hormone Pulse Generator and Stress Axis in Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT00921492
- Acronym / sponsor ID
- PCOSLFEA / PCOSLFEA-17611
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- Luteinizing hormone, Cortisol, HPA axis, HPO axis, Ovulation, Heart rate variability, Psychological distress and quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 16 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.
Hypothesis The overall hypothesis is that non-obese (BMI <30) women with PCOS have high luteinising hormone (LH) and cortisol pulse frequency and amplitude and that repeated low-frequency EA restore these alterations and induce ovulation.
Detailed description
Aim 1. Elucidate if low-frequency EA induce ovulation and restore LH frequency and amplitude as well as sex steroid secretion as compared to a control group receiving same amount of attention.
Aim 2. Elucidate if low-frequency EA restore cortisol frequency and amplitude compared to a control group receiving same amount of attention.
Aim 3. Elucidate if low-frequency EA restore psychological distress and quality of life as compared to a control group receiving same amount of attention.in women with PCOS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-frequency electro-acupuncture | Experimental | Device: Low-frequency electro-acupuncture (EA) |
| Meeting a therapist - attention | Active comparator | Other: Meeting a therapist - attention control |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 18 - 39 years, inclusive
- 30 ≤ BMI
- History of irregular menstrual cycles
- Clinical and/or biochemical androgen excess (determined during screening)
Key exclusion criteria (5 listed)
- Medical Exclusion Criteria
- History or clinical manifestation of; cardiovascular disease, diabetes (Type 1 or Type 2), any other significant endocrine or metabolic disorder.
- Regular use of medications for weight control, psychosis and thyroid disease. A 3 month washout period will be permitted for contraceptives.
- Psychiatric and Behavioral Exclusion Criteria
- Pregnant or breast-feeding women
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 |
|---|---|---|
| Low-frequency electro-acupuncture (EA)2 Hz EA during 30 minutes, twice a week, 14 weeks. | Device | Low-frequency electro-acupuncture |
| Meeting a therapist - attention controlMeeting a therapist, twice a week during 30 minutes in order to control for the increased amount of attention. | Other | Meeting a therapist - attention |
Primary outcome
Frequent blood sampling every 10th minute during an overnight stay in order to measure changes in LH and cortisol pulsatility before and after treatment. A third assessment will be made in those participants who ovulate during the 14 week study.
Time frame: 16 weeks
1 secondary outcome
Ovulation, health related quality of life
Time frame: 16 weeks
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 15 Aug 2018.
- Derived from this study: PubMed 42693220Samad M, Ek J, Kataoka J, Lindgren E, Ohlsson C, Wernstedt Asterholm I, Stener-Victorin E, Benrick A. Hypoadiponectinemia does not enhance anxiety-like behaviour in a lean PCOS-like mouse model. Sci Rep. 2026 Sep 3;16(1):27688. doi: 10.1038/s41598-026-69143-9.
- Derived from this study: PubMed 23482444Johansson J, Redman L, Veldhuis PP, Sazonova A, Labrie F, Holm G, Johannsson G, Stener-Victorin E. Acupuncture for ovulation induction in polycystic ovary syndrome: a randomized controlled trial. Am J Physiol Endocrinol Metab. 2013 May 1;304(9):E934-43. doi: 10.1152/ajpendo.00039.2013. Epub 2013 Mar 12.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-frequency electro-acupuncture (EA) in people with Polycystic Ovary Syndrome, run by Göteborg University at 1 site in Sweden.
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 4 inclusion and 5 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 15 Aug 2018. 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 Sweden. 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 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?
Frequent blood sampling every 10th minute during an overnight stay in order to measure changes in LH and cortisol pulsatility before and after treatment. A third assessment will be made in those participants who ovulate during the 14 week study. (time frame: 16 weeks). 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 NCT00921492, which also lists 2 linked publications.
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 15 Aug 2018.