The Correlation Between Ovarian Function and Serum Biomarkers

Shi Yun

Status: Enrolling

Conditions: Aging; Copper; Diminished Ovarian Reserve; Biomarker; Ceruloplasmin; Premature Ovarian Insufficiency

Treatments: Diagnostic Test: blood test

Study type: Observational

Funder types: Other

Identifiers

NCT06096766

2023DZMEC-489

Details and patient eligibility

About

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

Full 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.

Enrollment: 35 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

35 participants in 3 patient groups

Diminished Ovarian Reserve Group

Description:

women with DOR

Treatment:

Diagnostic Test: blood test

Premature Ovarian Insufficiency Group (POI)

Description:

women with premature ovarian insufficiency

Treatment:

Diagnostic Test: blood test

Control Group

Description:

women with normal menstruation and levels of sex hormones

Treatment:

Diagnostic Test: blood test