Primary Ovarian Insufficient Patients

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03989154

Enrollment

10000

Registered

2019-06-18

Start date

2010-01-01

Completion date

2050-12-31

Last updated

2019-06-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Related

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

China

Contacts

Primary ContactLanlan Fang, M.D.

fanglly@163.com13673355291

Outcome results