The Correlation Between Ovarian Function and Serum Biomarkers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-25

Study Completion Date

2025-11-11

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.

Conditions

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Premature Ovarian Insufficiency Diminished Ovarian Reserve Biomarker Copper Ceruloplasmin Aging

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Diminished Ovarian Reserve Group

women with DOR

blood test

Intervention Type DIAGNOSTIC_TEST

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.

Premature Ovarian Insufficiency Group (POI)

women with premature ovarian insufficiency

blood test

Intervention Type DIAGNOSTIC_TEST

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.

Control Group

women with normal menstruation and levels of sex hormones

blood test

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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blood test

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

1. 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.
2. 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.
3. 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

1. Patients with congenital gonadal developmental abnormalities or a family history similar to "early menopause".
2. Patients with acquired organic lesions or decreased ovarian function caused by ovarian surgery.
3. Patients who have undergone artificial cycle therapy with Western medicine or other endocrine treatments within the past three months.
4. Patients with severe primary diseases and mental disorders such as crdiovascular, cerebrovascular, liver, kidney, and hematopoietic system.
5. Patients during lactation or pregnancy.
6. Patients who are allergic to the drugs used in this study or have a history of allergic reactions to traditional Chinese medicine.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Responsible Party

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Shi Yun

Sponsor-Investigator

Responsibility Role SPONSOR_INVESTIGATOR