Acupuncture and Gonadotropin-releasing Hormone Pulse Generator and Stress Axis in Polycystic Ovary Syndrome
PCOSLFEA
Does Low-frequency Electro-acupuncture Restore Sensitivity of the Gonadotropin-releasing Hormone Pulse Generator and Stress Axis in Polycystic Ovary Syndrome
3 other identifiers
interventional
28
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2009
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 12, 2009
CompletedFirst Posted
Study publicly available on registry
June 16, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedAugust 15, 2018
August 1, 2018
1.8 years
June 12, 2009
August 13, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
16 weeks
Secondary Outcomes (1)
Ovulation, health related quality of life
16 weeks
Study Arms (2)
Low-frequency electro-acupuncture
EXPERIMENTALMeeting a therapist - attention
ACTIVE COMPARATORInterventions
2 Hz EA during 30 minutes, twice a week, 14 weeks.
Meeting a therapist, twice a week during 30 minutes in order to control for the increased amount of attention.
Eligibility Criteria
You may qualify if:
- years, inclusive
- ≤ BMI
- History of irregular menstrual cycles
- Clinical and/or biochemical androgen excess (determined during screening)
You may not qualify if:
- 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.
- Pregnant or breast-feeding women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute of Neuroscience and Physiology, Sahlgrenska Academy, Göteborg University
Gothenburg, 40530, Sweden
Related Publications (1)
Johansson 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.
PMID: 23482444DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2009
First Posted
June 16, 2009
Study Start
February 1, 2009
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
August 15, 2018
Record last verified: 2018-08