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The Relationship of PRL and Polycystic Ovary Syndrome (PCOS) in Taiwan's Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01117272
Recruitment Status : Completed
First Posted : May 5, 2010
Last Update Posted : November 14, 2013
Information provided by (Responsible Party):
Ming-I Hsu, Taipei Medical University WanFang Hospital

Brief Summary:

Polycystic ovarian syndrome (PCOS) is the most common endocrine disorder of reproductive-age women. According to Rotterdam 2003 criteria: at least two of three criteria are met, hyperandrogenism, chronic anovulation, and polycystic ovary. PCOS will cause irregular menstrual cycle, infertility, acne, hirsutism, obesity, or/and metabolic syndrome, diabetes that may increase risk of cardiovascular disease.

Hyperprolactinaemia is also a common problem in reproductive aged women. Both hyperprolactinaemia and PCOS had endocrine disorder and irregular menstrual cycle. Investigators hope to collect clinical data from PCOS and prolactinemia patients followed in Wang Fang hospital for many years in endocrinological and metabolical aspects for comparison. Investigators at the same time would like to understand more about other similarities and differences between these two endocrinological dysfunction for future study.

Condition or disease
Polycystic Ovary Syndrome

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Study Type : Observational
Actual Enrollment : 474 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Relationship of Metabolic Parameters, Endocrine and Prolactin Levels in Taiwan's Women With Polycystic Ovary Syndrome and Hyperprolactinemia.
Study Start Date : May 2009
Actual Primary Completion Date : February 2010
Actual Study Completion Date : April 2010

PCOS group
Who met the 2003 Rotterdam criteria.
Mild hyperprolactinaemia group
Who were diagnosed with prolactin levels above the upper limit of normal (24.29 ng/ml) and under 100 ng/ml.
Control group
Without PCOS and with normal prolactin levels.

Primary Outcome Measures :
  1. hyperprolactin [ Time Frame: Who visited the Reproductive Endocrinology Clinic at Taipei Medical University-Wan Fang Medical Center from April 2004 to June 2007 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Polycystic Ovary syndrome(PCOS)

Inclusion Criteria:

  • PCOM by ultrasound Diagnosis
  • Anovulation, Oligo menses
  • Hyperandrogenism

Exclusion Criteria:

  • Women who had been diagnosed with other etiology that should be excluded in PCOS diagnosis, such as hyperprolactinemia, hypogonadotropic hypogonadism, premature ovarian failure, congenital adrenal hyperplastic, androgen-secreting tumor, Cushing's syndrome, disorders of uterus( such as Asherman's syndrome, Mullerian agenesis), chromosomal anomalies( such as Turner syndrome).
  • Women who did not have sufficient clinical or biochemical records.
  • Girls who had menarche at <3 years of age and women who were >40 years of age.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01117272

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Taipei Medical University WanFang Hospital
Taipei, Taiwan, 116
Sponsors and Collaborators
Taipei Medical University WanFang Hospital
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Principal Investigator: Ming-I Hsu, MD Taipei Medical University WanFang Hospital

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Responsible Party: Ming-I Hsu, Attending Doctor, Taipei Medical University WanFang Hospital Identifier: NCT01117272     History of Changes
Other Study ID Numbers: WFH-PCOS-98009
First Posted: May 5, 2010    Key Record Dates
Last Update Posted: November 14, 2013
Last Verified: November 2013
Keywords provided by Ming-I Hsu, Taipei Medical University WanFang Hospital:
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Pathologic Processes
Ovarian Cysts
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases