Acupuncture and Gonadotropin-releasing Hormone Pulse Generator and Stress Axis in Polycystic Ovary Syndrome

Polycystic Ovary Syndrome Clinical Trial

— PCOSLFEA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00921492
• Other study ID #: PCOSLFEA-17611
• Secondary ID: 2008-72VP-15445-
• Status: Completed
• Phase: N/A
• Start date: February 2009
• Est. completion date: December 2010

Study information

• Verified date: August 2018
• Source: Göteborg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

Device:
• Low-frequency electro-acupuncture (EA)
2 Hz EA during 30 minutes, twice a week, 14 weeks.

Other:
• Meeting a therapist - attention control
Meeting a therapist, twice a week during 30 minutes in order to control for the increased amount of attention.

Locations

Country	Name	City	State
Sweden	Institute of Neuroscience and Physiology, Sahlgrenska Academy, Göteborg University	Göteborg

Sponsors (1)

Lead Sponsor	Collaborator
Göteborg University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Ovulation, health related quality of life		16 weeks