RecruitingNCT06096766

The Correlation Between Ovarian Function and Serum Biomarkers

Study on the Correlation Between Ovarian Function and Serum Biomarkers

Sponsor

Shi Yun

Enrollment

35 participants

Start Date

Oct 25, 2023

Study Type

OBSERVATIONAL

Conditions

Diminished ovarian reserve Aging Premature Ovarian Insufficiency Biomarker Copper Ceruloplasmin

Summary

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

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Inclusion Criteria13

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.
≤ 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 Criteria6

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.

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Interventions

DIAGNOSTIC_TESTblood 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.