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

NCT01117272 | Completed

• 1 other identifier: WFH-PCOS-98009
• Study Type: observational
• Target: 474
• Locations: 1 country
• Sites: 1

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.

Conditions

Polycystic Ovary Syndrome

Keywords

PCOS; hyperprolactinemia; obesity; hyperandrogenic

Outcome Measures

Primary Outcomes (1)

• hyperprolactin

  Who visited the Reproductive Endocrinology Clinic at Taipei Medical University-Wan Fang Medical Center from April 2004 to June 2007

Study Arms (3)

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.

Eligibility Criteria

• Age: 15 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Polycystic Ovary syndrome(PCOS)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taipei Medical University WanFang Hospital: lead

Study Sites (1)

Taipei Medical University WanFang Hospital

Taipei, Taipei, 116, Taiwan

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Hyperprolactinemia; Obesity

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ming-I Hsu, MD

  Taipei Medical University WanFang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Doctor

Study Record Dates

• First Submitted: May 3, 2010
• First Posted: May 5, 2010
• Study Start: May 1, 2009
• Primary Completion: February 1, 2010
• Study Completion: April 1, 2010
• Last Updated: November 14, 2013

Record last verified: 2013-11

Locations

TW (1)