the Correlation Between Ovarian Function and Serum Biomarkers

Study Overview
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Brief Summary
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The goal of this observational study is to find differences in serum biomarkers between ovarian function and normal individuals.

Detailed Description
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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.

Official Title
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Study on the Correlation Between Ovarian Function and Serum Biomarkers

Conditions
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Premature Ovarian Insufficiency, Diminished Ovarian Reserve, Biomarker, Copper, Ceruloplasmin, Aging

Intervention / Treatment
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* Diagnostic Test: blood test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Diminished Ovarian Reserve Group<br>women with DOR | Diagnostic Test: blood test<br>* Detection of serum levels of copper ions, iron ions, ceruloplasmin (CP), CuZn SOD, malondialdehyde (MDA), etc. Blood samples will be retained from the rest samples for sex hormones samples for testing sex hormones, which don't increase times of blood collection.<br>|
| Premature Ovarian Insufficiency Group (POI)<br>women with premature ovarian insufficiency | Diagnostic Test: blood test<br>* Detection of serum levels of copper ions, iron ions, ceruloplasmin (CP), CuZn SOD, malondialdehyde (MDA), etc. Blood samples will be retained from the rest samples for sex hormones samples for testing sex hormones, which don't increase times of blood collection.<br>|
| Control Group<br>women with normal menstruation and levels of sex hormones | Diagnostic Test: blood test<br>* Detection of serum levels of copper ions, iron ions, ceruloplasmin (CP), CuZn SOD, malondialdehyde (MDA), etc. Blood samples will be retained from the rest samples for sex hormones samples for testing sex hormones, which don't increase times of blood collection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| copper | the level of copper in blood sample | On the 2 4th day of menstruation (amenorrhea patients before and after taking medication) | 
| Iron ion | the level of Iron ion in blood sample | On the 2 4th day of menstruation (amenorrhea patients before and after taking medication) | 
| ceruloplasmin, CP | the level of ceruloplasmin in blood sample | On the 2 4th day of menstruation (amenorrhea patients before and after taking medication) | 
| CuZn-Superoxide Dismutase, CuZn-SOD/SOD1 | the level of CuZn-SOD/SOD1 in blood sample | On the 2 4th day of menstruation (amenorrhea patients before and after taking medication) | 
| Malondialdehyde，MDA | the level of MDA in blood sample | On the 2 4th day of menstruation (amenorrhea patients before and after taking medication) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| other relative biomarkers about copper/iron metabolism and oxidative stress | depending on the results of the five biomarkers above | On the 2 4th day of menstruation (amenorrhea patients before and after taking medication) |