Health TrialsbyHealthPanel

Multidisciplinary Diagnosis and Treatment of Polycystic Ovary Syndrome

ConditionPolycystic Ovary Syndrome
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-45
SponsorShanghai 10th People's Hospital

About this trial

The investigators collected clinical data and serum samples of patients with polycystic ovary syndrome (PCOS) in this study, used statistical software such as SPSS for date analysis, and used experimental techniques such as ELISA and flow cytometry to detect serum samples, aiming to explore the relationship between the body anthropometry, skin conditions, psychosomatic status, diet, sleep, exercise, glucose and lipid metabolism, gonadal hormones, and body fat distribution in patients with polycystic ovary syndrome, and to discovery new biomarkers. Multidisciplinary exploration of the mechanisms of disease occurrence and development, the establishment of a PCOS multicenter, multidisciplinary and multidimensional clinical research database, combined with the established statistical analysis strategy for big data and analysis, to promote the realization of more accurate personalized medicine.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female aged 18- 45;

Disqualifiers

Female patients younger than 18 years old or older than 45 years old;

Ovulatory disorders caused by premature ovarian failure, pituitary amenorrhea, hypothalamic amenorrhea, and thyroid dysfunction;

Congenital adrenal hyperplasia, reservoir Hin syndrome, hyperprolactinemia, adrenal tumors and other diseases that cause hyperandrogenism;

Abnormal liver or renal function((≥ 3 times of the upper limit of normal range)

Trial population

Polycystic ovary syndrome (PCOS) is a common dis-order in women that is characterized by hyperandro-genism (that is, evidence of excess male hormone or androgen effect; clinically, such as hirsut-ism, and/or biochemically, such as hyperandrogen aemia or excess levels of androgen), ovulatory dysfunction (including menstrual dysfunction) and polycystic ovarian morphology (PCOM; an excessive number of preantral follicles in the ovaries).

Trial design

Design model

Other

Time perspective

Cross-sectional

Treatments tested in this trial

  • This study does not involve any interventions

    Other intervention

    This study does not involve any interventions

Treatment groups

3,000 Participants
are divided into 2 treatment groups
Group A: PCOS1 intervention
Group B: NOPCOS1 intervention

Trial outcomes

Primary outcomes

1

Fibrinogen-like-protein 1 (FGL1)

Fibrinogen-like-protein 1 (FGL1), is a novel hepatokine that plays an important role in hepatic steatosis, insulin resistance and obesity. There is no maximum or minimum value for this parameter and the higher scores mean a worse outcome.

Time frame
baseline

Secondary outcomes

1

body mass index ,BMI

BMI=weight(kg)/height(m)\^2

Time frame
baseline
2

Waist/hip Ratio,WHR

WHR=Waist Circumference(cm)/Hip Circumference(cm)

Time frame
baseline
3

Number of menstruation in the last year

physiological parameter,the total number of menstrual periods in the last year

Time frame
baseline
4

Ferriman-Gallwey score

The minimum value of Ferriman-Gallwey score is 0 and the maximum value is 44. An Ferriman-Gallwey score greater than or equal to 6 is considered to be a clinical manifestation of androgen excess.

Time frame
Time Frame: baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai 10th People's Hospital

Lead sponsor

Source ClinicalTrials.gov
Apply now