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Clinical Trials in China / NCT06096766
Recruiting Observational

The Correlation Between Ovarian Function and Serum Biomarkers

NCT06096766 · tracked via the Priya Life Science China tracker
Sponsor
Shi Yun
Phase
Observational
Started
2023-10-25
Last updated
2024-12-09

Condition(s) studied

Premature Ovarian InsufficiencyDiminished Ovarian ReserveBiomarkerCopperCeruloplasminAging

Investigational drug(s) / intervention(s)

blood test

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.

Study summary

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

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
45 Years
Healthy volunteers
Accepted
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).

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Dongzhimen Hospital, Beijing University of Chinese Medicine Beijing China Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06096766 on ClinicalTrials.gov ↗ ← All trials in China