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RecruitingNCT03989154Updated Jun 19, 2019

Primary Ovarian Insufficient Patients

An observational study in Healthy Related, sponsored by The First Affiliated Hospital of Zhengzhou University. Recruiting at 1 site in China. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2019-06-19.

Sponsored by The First Affiliated Hospital of Zhengzhou University · Observational

From the registry’s dates

  • Started Jan 2010; still recruiting 16 years 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
10,000
Ages
18 Years to 40 Years
Sex
Female
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Study 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.

Read the 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.

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Conditions studied

  • Healthy Related
03

In context

Lead sponsor

The First Affiliated Hospital of Zhengzhou University is the lead sponsor of 123 studies on the registry; 72 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No
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

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

Exclusion Criteria:

-

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
10,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna
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What researchers measure

Primary outcomes

  1. FSH (Follicle stimulating hormone)

    mIU/mL

    Time frame: Change from Baseline FSH at each6 months

  2. LH (luteinizing hormone)

    mIU/mL

    Time frame: Change from Baseline LH at each6 months

  3. Estrogen

    pg/ml

    Time frame: Change from Baseline Estrogen at each6 months

  4. Progesterone

    ng/ml

    Time frame: Change from Baseline Progesterone at each6 months

Secondary outcomes

  1. Volume of uterus and ovary

    Record the Length (mm)\*Width (mm)\*Height (mm) of uterus, and each ovary

    Time frame: Change from Baseline volume at each6 months

07

Study locations

1 of 1 sites recruiting
  • Reproductive Medical Center, First Affiliated Hospital of Zhengzhou University
    Zhengzhou, Henan 450052, China
    Recruiting
08

References and documents

Publications

  • 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. PubMed 25681846 ↗
  • 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. PubMed 27571179 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 19, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03989154
Lead sponsor
The First Affiliated Hospital of Zhengzhou University
Responsible party
Yingpu Sun (Director of Reproductive Medical Center, The First Affiliated Hospital of Zhengzhou University) — Principal investigator
First posted
Jun 18, 2019
Start date
Jan 1, 2010
Primary completion
Dec 31, 2050 (estimated)
Completion
Dec 31, 2050 (estimated)
Last update
Jun 19, 2019

Study contacts

Lanlan Fang, M.D.
Contact
fanglly@163.com
13673355291

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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