Cardiovascular Diseases Clinical Trial
Official title:
Multicenter Cohort Study to Evaluate and to Protect Ovarian Function and Reproductive Function
The study will collect the clinical and biological data of the patients, the investigators could further analyse and identify the risk factors and optimize clinical treatment method. Besides, population-based healthy people with informed consent are also collected.
Status | Recruiting |
Enrollment | 6000 |
Est. completion date | July 2021 |
Est. primary completion date | May 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Karnofsky Performance Statue = 70, - WBC > 3,000/mm³, - Hb > 9.0g/dl, - Platelet > 100,000 /mm³, - SGOT/SGPT < 60 IU/L, - T-Bil < 1.5 mg/dL, - Cr < 1.2 mg/dL, - PaO2 > 80 torr, - normal ECG, - Written informed consent. Exclusion Criteria: - Patients without information, - clinical risk factors, - Patients who have active infection. |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
China | Huazhong University of Science and Technology | Wuhan | Hubei |
Lead Sponsor | Collaborator |
---|---|
Shixuan Wang | Huazhong University of Science and Technology, Shanghai Jiao Tong University School of Medicine, Sun Yat-sen University, Wuhan General Hospital of Guangzhou Military Command, Xinjiang Medical University, Zhengzhou University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | ovarian function including parameters FSH(mIu/ml), LH(mIu/ml), E2(pg/ml) and T(ng/dl) and reproductive function including pregnancy rate after treatment for young female patients who have benign or malignant tumor | FSH(mIu/ml), LH(mIu/ml), E2(pg/ml) and T(ng/dl) levels were measured using a chemiluminescence-based immunometric assay on an ADVIA Centaur immunoassay system (Siemens Healthcare Diagnostics Inc., Tarrytown, NY, USA). | up to 3 year | Yes |
Primary | ovarian function evaluation including parameters FSH(mIu/ml), LH(mIu/ml), E2(pg/ml), T(ng/dl) for individuals with normal ovarian function (more than 2 000 women) and ovarian failure(more than 1 000 women). | FSH(mIu/ml), LH(mIu/ml), E2(pg/ml), T(ng/dl) levels were measured using a chemiluminescence-based immunometric assay on an ADVIA Centaur immunoassay system (Siemens Healthcare Diagnostics Inc., Tarrytown, NY, USA). | up to 3 year | Yes |
Secondary | women's reproductive function including pregnancy rate | pregnancy rate was recorded once a year | up to 3 year | Yes |
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