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the Correlation Between Ovarian Function and Serum Biomarkers

Recruiting
18 - 45 years of age
Female
Phase N/A

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Overview

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

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

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.
        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).

Study details

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

NCT06096766

Shi Yun

25 January 2024

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