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

NCT ID: NCT00921492

Last Updated: 2018-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2010-12-31

Brief Summary

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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

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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

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Polycystic Ovary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Low-frequency electro-acupuncture

Group Type EXPERIMENTAL

Low-frequency electro-acupuncture (EA)

Intervention Type DEVICE

2 Hz EA during 30 minutes, twice a week, 14 weeks.

Meeting a therapist - attention

Group Type ACTIVE_COMPARATOR

Meeting a therapist - attention control

Intervention Type OTHER

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

Interventions

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Low-frequency electro-acupuncture (EA)

2 Hz EA during 30 minutes, twice a week, 14 weeks.

Intervention Type DEVICE

Meeting a therapist - attention control

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 18 - 39 years, inclusive
* 30 ≤ BMI
* History of irregular menstrual cycles
* Clinical and/or biochemical androgen excess (determined during screening)

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.


* Pregnant or breast-feeding women
Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Göteborg University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Institute of Neuroscience and Physiology, Sahlgrenska Academy, Göteborg University

Gothenburg, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type DERIVED
PMID: 23482444 (View on PubMed)

Other Identifiers

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2008-72VP-15445-01A

Identifier Type: -

Identifier Source: secondary_id

ALFFGBG-10984

Identifier Type: -

Identifier Source: secondary_id

PCOSLFEA-17611

Identifier Type: -

Identifier Source: org_study_id

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