Clinical Trials Directory

Trials / Completed

CompletedNCT04264832

Body Fat Distribution and Its Associated Factors in Chinese Women With Polycystic Ovary Syndrome

Department of Traditional Chinese Medicine (TCM), Center for Reproductive Medicine, Department of Obstetrics and Gynaecology, Peking University Third Hospital, Beijing 100191, China.

Status
Completed
Phase
Study type
Observational
Enrollment
733 (actual)
Sponsor
Peking University Third Hospital · Academic / Other
Sex
Female
Age
18 Years – 45 Years
Healthy volunteers
Accepted

Summary

To investigate the body fat distribution in chinese women with polycystic ovary syndrome (PCOS) and the association of those distribution with metabolic parameters, microeconomics, hormone profiles and psychological state.

Detailed description

The polycystic ovary syndrome (PCOS) is one of the most common endocrine and metabolic disorders in women of reproductive age. It is also one of the leading causes of anovulatory infertility and secondary amenorrhea, which represent major stress factors in the female life. In the previous studies, the investigators found that PCOS patients showed decreased quality-of-life and increased psychological disturbances compared with healthy controls. Body mass index (BMI) was associated with emotional disorders and physical aspects of quality-of-life and negative emotions were negatively correlated with BMI in PCOS patients.These results prompted that PCOS could be separated into at least two subtypes by the fat content. So the investigators expand the epidemiological investigation for comparing the body composition between the PCOS and the normal women, and finding specific biological indicators in different subtypes.

Conditions

Interventions

TypeNameDescription
OTHERClinical data collectionBasic characteristics: Participants were carefully characterized with regard to a general health history, a medical history, clinical, demographic and anthropomorphic measurements, skin problems (hirsutism is modified by Ferriman-Gallwey (mF-G) score , global acne score and premature alopecia). A transvaginal ultrasound scan was performed on every participant during a clinical examination to determine the number of follicles and ovarian volume. Metabolic and other assessments: General gynecological examination, prolactin, thyroid, androgen, LH, FSH, DA, 5-HT, metabonomics, glucose, insulin, triglyceride (TG), LDL and HDL were determined, OGTT was performed. Questionnaires: The perceived stress scale(Chinese 14-item PSS), self-rating anxiety scale (SAS), self-rating depressive scale(SDS) were used to assess the participants' mental health status. The MOS item short from health survey (SF-36) was used to assess the quality of life .

Timeline

Start date
2016-03-01
Primary completion
2021-05-01
Completion
2021-09-01
First posted
2020-02-11
Last updated
2021-09-29

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT04264832. Inclusion in this directory is not an endorsement.