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

G

Göteborg University

Status

Completed

Conditions

Polycystic Ovary Syndrome

Treatments

Other: Meeting a therapist - attention control
Device: Low-frequency electro-acupuncture (EA)

Study type

Interventional

Funder types

Other

Identifiers

NCT00921492
ALFFGBG-10984
PCOSLFEA-17611
2008-72VP-15445-01A

Details and patient eligibility

About

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.

Full 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.

Enrollment

28 patients

Sex

Female

Ages

18 to 39 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

28 participants in 2 patient groups

Low-frequency electro-acupuncture
Experimental group
Treatment:
Device: Low-frequency electro-acupuncture (EA)
Meeting a therapist - attention
Active Comparator group
Treatment:
Other: Meeting a therapist - attention control

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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