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

NCT ID: NCT01117272

Last Updated: 2013-11-14

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

Total Enrollment

474 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-05-31

Study Completion Date

2010-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Polycystic Ovary Syndrome

Keywords

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PCOS hyperprolactinemia obesity hyperandrogenic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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PCOS group

Who met the 2003 Rotterdam criteria.

No interventions assigned to this group

Mild hyperprolactinaemia group

Who were diagnosed with prolactin levels above the upper limit of normal (24.29 ng/ml) and under 100 ng/ml.

No interventions assigned to this group

Control group

Without PCOS and with normal prolactin levels.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

15 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Taipei Medical University WanFang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ming-I Hsu

Attending Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ming-I Hsu, MD

Role: PRINCIPAL_INVESTIGATOR

Taipei Medical University WanFang Hospital

Locations

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Taipei Medical University WanFang Hospital

Taipei, Taipei, Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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WFH-PCOS-98009

Identifier Type: -

Identifier Source: org_study_id