Cohort Study to Evaluate Ovarian Function

NCT ID: NCT02294500

Last Updated: 2016-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

6000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-07-31

Study Completion Date

2021-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Huazhong University of Science and Technology

OTHER

Sponsor Role collaborator

Wuhan General Hospital of Guangzhou Military Command

OTHER

Sponsor Role collaborator

Zhengzhou University

OTHER

Sponsor Role collaborator

Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role collaborator

Xinjiang Medical University

OTHER

Sponsor Role collaborator

Sun Yat-sen University

OTHER

Sponsor Role collaborator

Shixuan Wang

OTHER

Sponsor Role lead

Responsible Party

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Shixuan Wang

Study Chairman

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Shixuan Wang, MD.PHD.

Role: STUDY_CHAIR

Huazhong University of Science and Technology

Locations

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Huazhong University of Science and Technology

Wuhan, Hubei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Shixuan Wang

Role: CONTACT

86-27-8366-3078

Facility Contacts

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Shixuan Wang, MD. PhD.

Role: primary

86-27-8366-3078

References

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Wen J, Huang K, Du X, Zhang H, Ding T, Zhang C, Ma W, Zhong Y, Qu W, Liu Y, Li Z, Deng S, Luo A, Jin Y, Zhang J, Wang S. Can Inhibin B Reflect Ovarian Reserve of Healthy Reproductive Age Women Effectively? Front Endocrinol (Lausanne). 2021 Apr 14;12:626534. doi: 10.3389/fendo.2021.626534. eCollection 2021.

Reference Type DERIVED
PMID: 33935966 (View on PubMed)

Du X, Ding T, Zhang H, Zhang C, Ma W, Zhong Y, Qu W, Zheng J, Liu Y, Li Z, Huang K, Deng S, Ma L, Yang J, Jiang J, Yang S, Huang J, Wu M, Fang L, Lu Y, Luo A, Wang S. Age-Specific Normal Reference Range for Serum Anti-Mullerian Hormone in Healthy Chinese Han Women: A nationwide Population-Based Study. Reprod Sci. 2016 Aug;23(8):1019-27. doi: 10.1177/1933719115625843. Epub 2016 Jan 13.

Reference Type DERIVED
PMID: 26763552 (View on PubMed)

Other Identifiers

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OA-1-female

Identifier Type: -

Identifier Source: org_study_id

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