The Correlation Between Ovarian Function and Serum Biomarkers

NCT06096766 | Recruiting

• 1 other identifier: 2023DZMEC-489
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (5)

• 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)

Secondary Outcomes (1)

• other relative biomarkers about copper/iron metabolism and oxidative stress

  On the 2~4th day of menstruation (amenorrhea patients on the enrolled week)

Study Arms (3)

Diminished Ovarian Reserve Group

women with DOR

Diagnostic Test: blood test

Premature Ovarian Insufficiency Group (POI)

women with premature ovarian insufficiency

Diagnostic Test: blood test

Control Group

women with normal menstruation and levels of sex hormones

Diagnostic Test: blood test

Interventions

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.

Control Group; Diminished Ovarian Reserve Group; Premature Ovarian Insufficiency Group (POI)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: biological sex
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.
• 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.
• Selection criteria for POI patients are follows.
• ≤ 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.

You may not qualify if:

• Patients with congenital gonadal developmental abnormalities or a family history similar to "early menopause".
• Patients with acquired organic lesions or decreased ovarian function caused by ovarian surgery.
• Patients who have undergone artificial cycle therapy with Western medicine or other endocrine treatments within the past three months.
• Patients with severe primary diseases and mental disorders such as crdiovascular, cerebrovascular, liver, kidney, and hematopoietic system.
• Patients during lactation or pregnancy.
• Patients who are allergic to the drugs used in this study or have a history of allergic reactions to traditional Chinese medicine.

Sponsors & Collaborators

• Shi Yun: lead

Study Sites (1)

Dongzhimen Hospital, Beijing University of Chinese Medicine

Beijing, China

RECRUITING

MeSH Terms

Conditions

Primary Ovarian Insufficiency

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• 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

• 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

Central Study Contacts

Yun Shi, PhD

CONTACT

13717926522; zysyun@163.com

Ke Xu, Master

CONTACT

18610680372; 18610680372@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: October 18, 2023
• First Posted: October 24, 2023
• Study Start: October 25, 2023
• Primary Completion: November 11, 2025
• Study Completion: November 11, 2025
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)