The Correlation Between Ovarian Function and Serum Biomarkers

Recruiting now

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

In brief

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

Key facts

Study ID

NCT06096766

Run by

Shi Yun

People needed

35

Starts

2023-10-25

Expected to finish

2025-11-11

Last updated by the study team

2024-12-09

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Dongzhimen Hospital, Beijing University of Chinese Medicine — Beijing, China (enrolling)

Full record on ClinicalTrials.gov

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