Cohort Study to Evaluate Ovarian Function

Cardiovascular Diseases Clinical Trial

Official title:

Multicenter Cohort Study to Evaluate and to Protect Ovarian Function and Reproductive Function

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02294500
• Other study ID #: OA-1-female
• Status: Recruiting
• Phase: N/A
• First received: September 10, 2014
• Last updated: April 25, 2016
• Start date: July 2011
• Est. completion date: July 2021

Study information

• Verified date: April 2016
• Source: Huazhong University of Science and Technology
• Contact: Shixuan Wang
• Phone: 86-27-8366-3078
• Email: sxwang2012[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

Menopause is the last step in the process of ovarian ageing. Decrease in follicle numbers dictates the onset of cycle irregularity and the cessation of menses. At the same time, decaying in oocyte quality contributes to the gradual decline in fertility. Endocrine changes mainly depend on the decline in the negative feedback by ovarian factors at the hypothalamo-pituitary unit. The declining antral follicle cohort(AFC) with age first results in gradually elevated FSH levels. The gradual decline in the size of AFC is best represented by decreasing levels of anti-Mullerian hormone. The identification of women who have severely decreased ovarian reserve is clinically relevant. Ovarian reserve tests have appeared to be fairly accurate in predicting response to ovarian stimulation in the assisted reproductive technology (ART) setting. The capacity to predict the chances for spontaneous pregnancy or pregnancy after ART appears very limited. As menopause and the preceding decline in oocyte quality seem to have a fixed time interval, tests that predict the age at menopause may be useful to assess individual reproductive lifespan like genetic studies, ovarian ageing mechanism studies and epigenetic studies.

Heart disease remains a major cause of death among women in China. We focuses on physiologic endogenous sex steroid levels and heart disease especially for CAD among postmenopausal women with natural or surgical menopause. Now there are more and more reasons to seek evidence for associations of circulating estrogen or other endogenous sex steroid levels and CAD. In the future, we design a cohort study to confirm whether ovarian sex steroid hormonal changes is associated with CAD postmenopausal women, or there may be other components explaining the gender differences in CAD patterns.

Premature ovarian failure(POF), is a disorder of infertility characterized by amenorrhoea, low estrogen levels and increased gonadotropin levels in women aged <40 years. POF is the result of premature exhaustion of the follicle pool or can be attributed to follicular dysfunction, for example, owing to mutations in the FSH receptor or steroidogenic cell autoimmunity. Moreover, advances in cancer therapeutics over the past decades have led to increasing survival rates for both paediatric and adult malignancies. Given the gonadotoxic effect of many cancer treatments, more women develop POF. Markers that predict whether women are at risk of POF would, therefore, aid in early diagnosis and fertility counselling.

The history of past and present status has been taken in our research. Women on the process of natural aging and disease-induced ovarian aging are all included. The key factors that influence ovary aging may be identified by epidemiological and molecular biological research.

Recruitment information / eligibility

• 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Female Infertility Due to Diminished Ovarian Reserve
• Infertility, Female
• Menopausal Syndrome
• Sexual Function and Fertility Disorders

Locations

Country	Name	City	State
China	Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (7)

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

Country where clinical trial is conducted

China, 

Outcome

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