Reproductive Medical Center, First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052, China
Location status: Recruiting
Recruiting
NCT Number: NCT03989154
Primary Ovarian Insufficient Patients
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–40 year
Sex eligibility
Female
Study type
Observational
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
-
Treatment and study plan
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
Time frame: Change from Baseline volume at each6 months
Record the Length (mm)*Width (mm)*Height (mm) of uterus, and each ovary
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
The First Affiliated Hospital of Zhengzhou University
Other
Registry information
Official study title
Prospective Cohort Study for Primary Ovarian Insufficient Patients in Clinical Reproductive Medicine Management System/Electronic Medical Record Cohort Database (CCRM/EMRCD)
Important dates
- Study start
- 2010
- Primary completion
- 2050
- Study completion
- 2050
- First posted
- Jun 18, 2019
- Registry last updated
- Jun 19, 2019
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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