Prospective Cohort Study for Primary Ovarian Insufficient Patients in Clinical Reproductive Medicine Management System/Electronic Medical Record Cohort Database (CCRM/EMRCD)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 10,000
- Locations
- 1
- Primary Endpoint
- FSH (Follicle stimulating hormone)
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
- Not provided
Outcomes
Primary Outcomes
FSH (Follicle stimulating hormone)
Time Frame: Change from Baseline FSH at each6 months
mIU/mL
LH (luteinizing hormone)
Time Frame: Change from Baseline LH at each6 months
mIU/mL
Estrogen
Time Frame: Change from Baseline Estrogen at each6 months
pg/ml
Progesterone
Time Frame: Change from Baseline Progesterone at each6 months
ng/ml
Secondary Outcomes
- Volume of uterus and ovary(Change from Baseline volume at each6 months)
Investigators
Yingpu Sun
Director of Reproductive Medical Center
The First Affiliated Hospital of Zhengzhou University