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The goal of this observational study is to find differences in serum biomarkers between ovarian function and normal individuals.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diminished Ovarian Reserve Group | women with DOR |
| |
| Premature Ovarian Insufficiency Group (POI) | women with premature ovarian insufficiency |
| |
| Control Group | women with normal menstruation and levels of sex hormones |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| blood test | Diagnostic 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. |
| Measure | Description | Time Frame |
|---|---|---|
| copper | the level of copper in blood sample | On the 2~4th day of menstruation (amenorrhea patients on the enrolled week) |
| Iron ion | the level of Iron ion in blood sample | On the 2~4th day of menstruation (amenorrhea patients on the enrolled week) |
| ceruloplasmin, CP | the level of ceruloplasmin in blood sample | On the 2~4th day of menstruation (amenorrhea patientson the enrolled week) |
| CuZn-Superoxide Dismutase, CuZn-SOD/SOD1 | the level of CuZn-SOD/SOD1 in blood sample | On the 2~4th day of menstruation (amenorrhea patients on the enrolled week) |
| Malondialdehyde,MDA | the level of MDA in blood sample | On the 2~4th day of menstruation (amenorrhea patients on the enrolled week) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 on the enrolled week) |
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Inclusion Criteria:
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.
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.
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.
Exclusion Criteria:
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).
biological sex
Visited the gynecology clinic of Dongzhimen Hospital from November 2023 to October 2024. Upon examination of sexual hormones or AMH, it was considered that patients with Diminished Ovarian Reserve (DOR), premature ovarian insufficiency (POI), and healthy individuals had decreased ovarian reserve function.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yun Shi, PhD | Contact | 13717926522 | zysyun@163.com | |
| Ke Xu, Master | Contact | 18610680372 | 18610680372@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yun Shi, PhD | Dongzhimen Hospital of Beijing University of Chinese Medicine | Study Director |
| Ke Xu, Master | Dongzhimen Hospital of Beijing University of Chinese Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dongzhimen Hospital, Beijing University of Chinese Medicine | Recruiting | Beijing | China |
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| ID | Term |
|---|---|
| D016649 | Primary Ovarian Insufficiency |
| ID | Term |
|---|---|
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D006403 | Hematologic Tests |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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|
| Jing Y Shao, Master | Dongzhimen Hospital of Beijing University of Chinese Medicine | Study Chair |
| Xuan kai Cai, Master | Shenzhen Bao'an Authentic TCM Therapy Hospital | Study Chair |
| Qin Y Liu, Bachelor | Dongzhimen Hospital of Beijing University of Chinese Medicine | Study Chair |
| Xi Y Li, Bachelor | Dongzhimen Hospital of Beijing University of Chinese Medicine | Study Chair |
| Fei Yan, Master | Dongzhimen Hospital of Beijing University of Chinese Medicine | Study Chair |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |