NCT02294500

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
6,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

September 10, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 19, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
5.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

April 27, 2016

Status Verified

April 1, 2016

Enrollment Period

4.8 years

First QC Date

September 10, 2014

Last Update Submit

April 25, 2016

Conditions

Female Infertility Due to Diminished Ovarian ReserveMenopausal SyndromeSexual Function and Fertility DisordersCardiovascular Diseases

Keywords

ovarian functionfemaleGenital Function

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • women's reproductive function including pregnancy rate

    up to 3 year

Other Outcomes (1)

  • 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

    up to 3 year

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

women with normal ovarian function or decreased ovarian function

You may qualify if:

  • 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.

You may not qualify if:

  • Patients without information,
  • clinical risk factors,
  • Patients who have active infection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Huazhong University of Science and Technology

Wuhan, Hubei, 430000, China

RECRUITING

Related Publications (2)

  • 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.

    PMID: 33935966DERIVED

  • 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.

    PMID: 26763552DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Our biospecimen included blood, serum, plasma and other body fluid and tissues

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Shixuan Wang, MD.PHD.

    Huazhong University of Science and Technology

    STUDY CHAIR

Central Study Contacts

Shixuan Wang

CONTACT

86-27-8366-3078sxwang2012@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Study Chairman

Study Record Dates

First Submitted

September 10, 2014

First Posted

November 19, 2014

Study Start

July 1, 2011

Primary Completion

May 1, 2016

Study Completion

July 1, 2021

Last Updated

April 27, 2016

Record last verified: 2016-04

Locations

CN(1)