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Does Low-frequency Electro-acupuncture Restore Sensitivity of the Gonadotropin-releasing Hormone Pulse Generator and Stress Axis in Polycystic Ovary Syndrome


N/A
18 Years
39 Years
Not Enrolling
Female
Polycystic Ovary Syndrome

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Trial Information

Does Low-frequency Electro-acupuncture Restore Sensitivity of the Gonadotropin-releasing Hormone Pulse Generator and Stress Axis in Polycystic Ovary Syndrome


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.


Inclusion Criteria:



- 18 - 39 years, inclusive

- 30 ≤ BMI

- History of irregular menstrual cycles

- Clinical and/or biochemical androgen excess (determined during screening)

Exclusion Criteria:

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

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.

Outcome Time Frame:

16 weeks

Safety Issue:

Yes

Authority:

Sweden: Regional Ethical Review Board

Study ID:

PCOSLFEA-17611

NCT ID:

NCT00921492

Start Date:

February 2009

Completion Date:

December 2010

Related Keywords:

  • Polycystic Ovary Syndrome
  • Luteinizing hormone
  • Cortisol
  • HPA axis
  • HPO axis
  • Ovulation
  • Heart rate variability
  • Psychological distress and quality of life
  • Polycystic Ovary Syndrome

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