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)
copper — On the 2~4th day of menstruation (amenorrhea patients on the enrolled week) the level of copper in blood sample
Iron ion — On the 2~4th day of menstruation (amenorrhea patients on the enrolled week) the level of Iron ion in blood sample
ceruloplasmin, CP — On the 2~4th day of menstruation (amenorrhea patientson the enrolled week) the level of ceruloplasmin in blood sample
CuZn-Superoxide Dismutase, CuZn-SOD/SOD1 — On the 2~4th day of menstruation (amenorrhea patients on the enrolled week) the level of CuZn-SOD/SOD1 in blood sample
Malondialdehyde,MDA — On the 2~4th day of menstruation (amenorrhea patients on the enrolled week) the level of MDA in blood sample
Trial sites (1)
Facility
City
Region
Status
Dongzhimen Hospital, Beijing University of Chinese Medicine
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.
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