Study on the Correlation Between Ovarian Function and Serum Biomarkers
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Premature Ovarian Insufficiency
- Sponsor
- Shi Yun
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- copper
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Shi Yun
Sponsor-Investigator
Dongzhimen Hospital, Beijing
Eligibility Criteria
Inclusion Criteria
- •The selection criteria for healthy individuals are follows.
- •women aged 18-
- •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-
- •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.
Exclusion Criteria
- •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).
Outcomes
Primary Outcomes
copper
Time Frame: On the 2~4th day of menstruation (amenorrhea patients on the enrolled week)
the level of copper in blood sample
Iron ion
Time Frame: On the 2~4th day of menstruation (amenorrhea patients on the enrolled week)
the level of Iron ion in blood sample
ceruloplasmin, CP
Time Frame: On the 2~4th day of menstruation (amenorrhea patientson the enrolled week)
the level of ceruloplasmin in blood sample
CuZn-Superoxide Dismutase, CuZn-SOD/SOD1
Time Frame: On the 2~4th day of menstruation (amenorrhea patients on the enrolled week)
the level of CuZn-SOD/SOD1 in blood sample
Malondialdehyde，MDA
Time Frame: On the 2~4th day of menstruation (amenorrhea patients on the enrolled week)
the level of MDA in blood sample
Secondary Outcomes
- other relative biomarkers about copper/iron metabolism and oxidative stress(On the 2~4th day of menstruation (amenorrhea patients on the enrolled week))