Status:
RECRUITING
The Correlation Between Ovarian Function and Serum Biomarkers
Lead Sponsor:
Shi Yun
Conditions:
Premature Ovarian Insufficiency
Diminished Ovarian Reserve
Eligibility:
FEMALE
18-45 years
Brief Summary
The goal of this observational study is to find differences in serum biomarkers between ovarian function and normal individuals.
Detailed Description
Collect the serum of the observation group and control group volunteers, and measure the levels of copper ions, iron ions, ceruloplasmin (CP), CuZn SOD, malondialdehyde (MDA), etc. in the serum.
Eligibility Criteria
Inclusion
- The selection criteria for healthy individuals are follows.
- women aged 18-45.
- Basic FSH\<10IU/L, and AMH is within the normal range.
- Regular menstruation.
- Agree and sign an informed consent form.
- The selection criteria for DOR patients are follows.
- women aged 18-45.
- For two consecutive menstrual cycles, 25 ≥ basal FSH ≥ 10IU/L or AMH\<1.1ng/ml.
- Agree and sign an informed consent form.
- Selection criteria for POI patients are follows.
- 18 ≤ females aged \<40 years old.
- Two consecutive menstrual cycles with basal FSH\>25IU/L or AMH\<1.1ng/ml.
- Agree and sign an informed consent form.
Exclusion
- Patients with congenital gonadal developmental abnormalities or a family history similar to "early menopause".
- Patients with acquired organic lesions or decreased ovarian function caused by ovarian surgery.
- Patients who have undergone artificial cycle therapy with Western medicine or other endocrine treatments within the past three months.
- Patients with severe primary diseases and mental disorders such as crdiovascular, cerebrovascular, liver, kidney, and hematopoietic system.
- Patients during lactation or pregnancy.
- Patients who are allergic to the drugs used in this study or have a history of allergic reactions to traditional Chinese medicine.
- Those who meet any of the above 5 criteria for DOR and POI will be excluded and not included in this study. The exclusion criteria for healthy subjects are as (1), (3), (4), and (5).
Key Trial Info
Start Date :
October 25 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 11 2025
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT06096766
Start Date
October 25 2023
End Date
November 11 2025
Last Update
December 9 2024
Active Locations (1)
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1
Dongzhimen Hospital, Beijing University of Chinese Medicine
Beijing, China