Clinical trial NCT06096766: The Correlation Between Ovarian Function and Serum Biomarkers
Official title: Study on the Correlation Between Ovarian Function and Serum Biomarkers
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Premature Ovarian Insufficiency
Diminished Ovarian Reserve
Biomarker
Copper
Ceruloplasmin
Aging
Lead sponsor: Dongzhimen Hospital, Beijing
Sponsor class: OTHER
First posted: 2023-10-24
Enrollment: 35
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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

Detailed 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.

Eligibility criteria: 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 outcomes:
measure: copper
timeFrame: On the 2~4th day of menstruation (amenorrhea patients on the enrolled week)
measure: Iron ion
timeFrame: On the 2~4th day of menstruation (amenorrhea patients on the enrolled week)
measure: ceruloplasmin, CP
timeFrame: On the 2~4th day of menstruation (amenorrhea patientson the enrolled week)
measure: CuZn-Superoxide Dismutase, CuZn-SOD/SOD1
timeFrame: On the 2~4th day of menstruation (amenorrhea patients on the enrolled week)
measure: Malondialdehyde，MDA
timeFrame: On the 2~4th day of menstruation (amenorrhea patients on the enrolled week)
Secondary outcomes:
measure: other relative biomarkers about copper/iron metabolism and oxidative stress
timeFrame: On the 2~4th day of menstruation (amenorrhea patients on the enrolled week)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Dongzhimen Hospital, Beijing University of Chinese Medicine
Study officials:
affiliation: Dongzhimen Hospital of Beijing University of Chinese Medicine
name: Yun Shi, PhD
role: STUDY_DIRECTOR
affiliation: Dongzhimen Hospital of Beijing University of Chinese Medicine
name: Ke Xu, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: Dongzhimen Hospital of Beijing University of Chinese Medicine
name: Jing Y Shao, Master
role: STUDY_CHAIR
affiliation: Shenzhen Bao'an Authentic TCM Therapy Hospital
name: Xuan kai Cai, Master
role: STUDY_CHAIR
affiliation: Dongzhimen Hospital of Beijing University of Chinese Medicine
name: Qin Y Liu, Bachelor
role: STUDY_CHAIR
affiliation: Dongzhimen Hospital of Beijing University of Chinese Medicine
name: Xi Y Li, Bachelor
role: STUDY_CHAIR
affiliation: Dongzhimen Hospital of Beijing University of Chinese Medicine
name: Fei Yan, Master
role: STUDY_CHAIR
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