the Correlation Between Ovarian Function and Serum Biomarkers

Aging Clinical Trial

Official title:

Study on the Correlation Between Ovarian Function and Serum Biomarkers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06096766
• Other study ID #: 2023DZMEC-489
• Status: Recruiting
• 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
• 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).

Related Conditions & MeSH terms

• Aging
• Biomarker
• Diminished Ovarian Reserve
• Menopause, Premature
• Premature Ovarian Insufficiency
• Primary Ovarian Insufficiency

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)