the Correlation Between Ovarian Function and Serum Biomarkers

October 25, 2023 updated by: Shi Yun

Study on the Correlation Between Ovarian Function and Serum Biomarkers

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

35

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Dongzhimen Hospital, Beijing University of Chinese Medicine
        • Contact:
        • Principal Investigator:
          • Yun Shi, phD
        • Sub-Investigator:
          • Ke Xu, Master

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Diminished Ovarian Reserve Group
women with DOR
Diagnostic test: 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.
Premature Ovarian Insufficiency Group (POI)
women with premature ovarian insufficiency
Diagnostic test: 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.
Control Group
women with normal menstruation and levels of sex hormones
Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
copper
Time Frame: On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)
the level of copper in blood sample
On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)
Iron ion
Time Frame: On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)
the level of Iron ion in blood sample
On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)
ceruloplasmin, CP
Time Frame: On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)
the level of ceruloplasmin in blood sample
On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)
CuZn-Superoxide Dismutase, CuZn-SOD/SOD1
Time Frame: On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)
the level of CuZn-SOD/SOD1 in blood sample
On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)
Malondialdehyde，MDA
Time Frame: On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)
the level of MDA in blood sample
On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
other relative biomarkers about copper/iron metabolism and oxidative stress
Time Frame: On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)
depending on the results of the five biomarkers above
On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shi Yun

Investigators

  • Study Director: Yun Shi, PhD, Dongzhimen Hospital of Beijing University of Chinese Medicine
  • Principal Investigator: Ke Xu, Master, Dongzhimen Hospital of Beijing University of Chinese Medicine
  • Study Chair: 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 25, 2023

Primary Completion (Estimated)

October 24, 2024

Study Completion (Estimated)

October 24, 2024

Study Registration Dates

First Submitted

October 18, 2023

First Submitted That Met QC Criteria

October 18, 2023

First Posted (Actual)

October 24, 2023

Study Record Updates

Last Update Posted (Actual)

October 26, 2023

Last Update Submitted That Met QC Criteria

October 25, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023DZMEC-489

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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