Clinical trial NCT03989154: Primary Ovarian Insufficient Patients
Official title: Prospective Cohort Study for Primary Ovarian Insufficient Patients in Clinical Reproductive Medicine Management System/Electronic Medical Record Cohort Database (CCRM/EMRCD)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Healthy Related
Lead sponsor: The First Affiliated Hospital of Zhengzhou University
Sponsor class: OTHER
First posted: 2019-06-18
Enrollment: 10000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: (1) younger than 40 years of age; (2) 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

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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: FSH (Follicle stimulating hormone)
timeFrame: Change from Baseline FSH at each6 months
measure: LH (luteinizing hormone)
timeFrame: Change from Baseline LH at each6 months
measure: Estrogen
timeFrame: Change from Baseline Estrogen at each6 months
measure: Progesterone
timeFrame: Change from Baseline Progesterone at each6 months
Secondary outcomes:
measure: Volume of uterus and ovary
timeFrame: Change from Baseline volume at each6 months
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Reproductive Medical Center, First Affiliated Hospital of Zhengzhou University
state: Henan
Study officials:
References:
citation: 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.
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. doi: 10.1210/jc.2016-1589. Epub 2016 Aug 29.