Primary Ovarian Insufficient Patients

NCT ID: NCT03989154

Last Updated: 2019-06-19

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

RECRUITING

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-01

Study Completion Date

2050-12-31

Brief Summary

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The Prospective Cohort Study for Primary Ovarian Insufficient Patients was set up to investigate the short- and long-term health consequences in Reproductive Medical Center, First Affiliated Hospital of Zhengzhou University, China.

Detailed Description

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Premature ovarian insufficiency (POI) is a rare cause of infertility in women affecting 1% of the population. It is characterized by amenorrhea, hypoestrogenism and elevated gonadotrophin levels in women younger than 40 years of age. Other than the reproductive outcome of these patients, the short- and long-term health consequences are still unknown.

Since last decade, Clinical Reproductive Medicine Management System/Electronic Medical Record Cohort Database (CCRM/EMRCD) has been used in Reproductive Medical Center, First Affiliated Hospital of Zhengzhou University, and Henan Province Key Laboratory for Reproduction and Genetics. Information of patients (POI, PCOS, Endometriosis, azoospermia, ect) were recorded comprehensively. The current project plans to recruit POI participants in our center. Biological samples, questionnaires and short/long term health data will be collected. The study is aimed to provide evidence for POI prognosis.

Conditions

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Healthy Related

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* younger than 40 years of age
* at least four or more months of amenorrhea, two or more instances in which the serum FSH level is \> 40 U/L (i.e., two inspections at intervals of 1 month or more), with an oestradiol level of \<20pg/ml

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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The First Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role lead

Responsible Party

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Yingpu Sun

Director of Reproductive Medical Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Reproductive Medical Center, First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Lanlan Fang, M.D.

Role: CONTACT

13673355291

Facility Contacts

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Zhiqin Bu, M.D.

Role: primary

15981978863

References

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Kovanci E, Schutt AK. Premature ovarian failure: clinical presentation and treatment. Obstet Gynecol Clin North Am. 2015 Mar;42(1):153-61. doi: 10.1016/j.ogc.2014.10.004.

Reference Type BACKGROUND
PMID: 25681846 (View on PubMed)

Zhai J, Yao G, Dong F, Bu Z, Cheng Y, Sato Y, Hu L, Zhang Y, Wang J, Dai S, Li J, Sun J, Hsueh AJ, Kawamura K, Sun Y. In Vitro Activation of Follicles and Fresh Tissue Auto-transplantation in Primary Ovarian Insufficiency Patients. J Clin Endocrinol Metab. 2016 Nov;101(11):4405-4412. doi: 10.1210/jc.2016-1589. Epub 2016 Aug 29.

Reference Type BACKGROUND
PMID: 27571179 (View on PubMed)

Other Identifiers

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RMCZZU-POI cohort study

Identifier Type: -

Identifier Source: org_study_id

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