Primary Ovarian Insufficient Patients

Healthy Related Clinical Trial

Official title:

Prospective Cohort Study for Primary Ovarian Insufficient Patients in Clinical Reproductive Medicine Management System/Electronic Medical Record Cohort Database (CCRM/EMRCD)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03989154
• Other study ID #: RMCZZU-POI cohort study
• Status: Recruiting
• Start date: January 1, 2010
• Est. completion date: December 31, 2050

Study information

• Verified date: June 2019
• Source: The First Affiliated Hospital of Zhengzhou University
• Contact: Lanlan Fang, M.D.
• Phone: 13673355291
• Email: fanglly[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: December 31, 2050
• Est. primary completion date: December 31, 2050
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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:

-

Related Conditions & MeSH terms

• Healthy Related

Locations

Country	Name	City	State
China	Reproductive Medical Center, First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Zhengzhou University

Country where clinical trial is conducted

China, 

References & Publications (2)

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. Review. — View Citation

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. Epub 2016 Aug 29. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FSH (Follicle stimulating hormone)	mIU/mL	Change from Baseline FSH at each6 months
Primary	LH (luteinizing hormone)	mIU/mL	Change from Baseline LH at each6 months
Primary	Estrogen	pg/ml	Change from Baseline Estrogen at each6 months
Primary	Progesterone	ng/ml	Change from Baseline Progesterone at each6 months
Secondary	Volume of uterus and ovary	Record the Length (mm)*Width (mm)*Height (mm) of uterus, and each ovary	Change from Baseline volume at each6 months