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The Correlation Between Ovarian Function and Serum Biomarkers

Study on the Correlation Between Ovarian Function and Serum Biomarkers

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06096766
Enrollment
35
Registered
2023-10-24
Start date
2023-10-25
Completion date
2025-11-11
Last updated
2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging, Biomarker, Ceruloplasmin, Copper, Diminished Ovarian Reserve, Premature Ovarian Insufficiency

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.

Interventions

DIAGNOSTIC_TESTblood 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.

Sponsors

Shi Yun
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Iron ionOn the 2~4th day of menstruation (amenorrhea patients on the enrolled week)the level of Iron ion in blood sample
ceruloplasmin, CPOn the 2~4th day of menstruation (amenorrhea patientson the enrolled week)the level of ceruloplasmin in blood sample
CuZn-Superoxide Dismutase, CuZn-SOD/SOD1On the 2~4th day of menstruation (amenorrhea patients on the enrolled week)the level of CuZn-SOD/SOD1 in blood sample
Malondialdehyde,MDAOn the 2~4th day of menstruation (amenorrhea patients on the enrolled week)the level of MDA in blood sample
copperOn the 2~4th day of menstruation (amenorrhea patients on the enrolled week)the level of copper in blood sample

Secondary

MeasureTime frameDescription
other relative biomarkers about copper/iron metabolism and oxidative stressOn the 2~4th day of menstruation (amenorrhea patients on the enrolled week)depending on the results of the five biomarkers above

Countries

China

Contacts

Primary ContactYun Shi, PhD
zysyun@163.com13717926522
Backup ContactKe Xu, Master
18610680372@163.com18610680372

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026