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Completed

NCT Number: NCT00921492

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

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.

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Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Urogenital Diseases

Age range

18 year–39 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Neuroscience and Physiology, Sahlgrenska Academy, Göteborg University

Gothenburg, 40530, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low-frequency electro-acupuncture (EA)

Device

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

Meeting a therapist - attention control

Other

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

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.

    Time frame: 16 weeks

Secondary outcomes

  1. Ovulation, health related quality of life

    Time frame: 16 weeks

Sponsors and collaborators

Lead sponsor

Göteborg University

Other

Registry information

Official study title

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

Acronym: PCOSLFEA

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jun 16, 2009
Registry last updated
Aug 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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