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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06096766
Other study ID # 2023DZMEC-489
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 25, 2023
Est. completion date October 24, 2024

Study information

Verified date October 2023
Source Dongzhimen Hospital, Beijing
Contact Yun Shi, PhD
Phone 13717926522
Email zysyun@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 35
Est. completion date October 24, 2024
Est. primary completion date October 24, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
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 Design


Intervention

Diagnostic 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.

Locations

Country Name City State
China Dongzhimen Hospital, Beijing University of Chinese Medicine Beijing

Sponsors (1)

Lead Sponsor Collaborator
Shi Yun

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary copper the level of copper in blood sample On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)
Primary Iron ion the level of Iron ion in blood sample On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)
Primary ceruloplasmin, CP the level of ceruloplasmin in blood sample On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)
Primary CuZn-Superoxide Dismutase, CuZn-SOD/SOD1 the level of CuZn-SOD/SOD1 in blood sample On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)
Primary Malondialdehyde,MDA the level of MDA in blood sample On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)
Secondary other relative biomarkers about copper/iron metabolism and oxidative stress depending on the results of the five biomarkers above On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)
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