Primary Ovarian Insufficient Patients

Recruiting

• Conditions: Healthy Related

• Registration Number: NCT03989154
• Lead Sponsor: The First Affiliated Hospital of Zhengzhou University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2010-01-01
• Status Verified: 2019-06
• Study First Submitted: 2019-06-13
• Study First Submitted QC: 2019-06-17
• Study First Posted: 2019-06-18
• Last Update Submitted: 2019-06-18
• Last Update Posted: 2019-06-19
• Primary Completion: 2050-12-31
• Study Completion: 2050-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 10000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
FSH (Follicle stimulating hormone)	Change from Baseline FSH at each6 months	mIU/mL
LH (luteinizing hormone)	Change from Baseline LH at each6 months	mIU/mL
Estrogen	Change from Baseline Estrogen at each6 months	pg/ml
Progesterone	Change from Baseline Progesterone at each6 months	ng/ml

Secondary Outcome Measures

Name	Time	Method
Volume of uterus and ovary	Change from Baseline volume at each6 months	Record the Length (mm)\*Width (mm)\*Height (mm) of uterus, and each ovary

Trial Locations

Locations (1)

Reproductive Medical Center, First Affiliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, Henan, China