The Correlation Between Ovarian Function and Serum Biomarkers

Recruiting

• Conditions: Copper; Biomarker; Aging; Diminished Ovarian Reserve; Premature Ovarian Insufficiency; Ceruloplasmin
• Interventions: Diagnostic Test: blood test

• Registration Number: NCT06096766
• Lead Sponsor: Shi Yun

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.

Study Timeline

• Study First Submitted: 2023-10-18
• Study First Submitted QC: 2023-10-18
• Study First Posted: 2023-10-24
• Study Start: 2023-10-25
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-09
• Primary Completion: 2025-11-11
• Study Completion: 2025-11-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 35

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Diminished Ovarian Reserve Group	blood test	women with DOR
Premature Ovarian Insufficiency Group (POI)	blood test	women with premature ovarian insufficiency
Control Group	blood test	women with normal menstruation and levels of sex hormones

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
other relative biomarkers about copper/iron metabolism and oxidative stress	On the 2~4th day of menstruation (amenorrhea patients on the enrolled week)	depending on the results of the five biomarkers above

Trial Locations

Locations (1)

Dongzhimen Hospital, Beijing University of Chinese Medicine; 🇨🇳 Beijing, China