Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06096766

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Dongzhimen Hospital, Beijing University of Chinese Medicine

Beijing, China

Location status: Recruiting

Location contact

Ke Xu, Master

CONTACT

Xueting Han

CONTACT

[email protected]

+861084012709

Yun Shi, phD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • 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

  • 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.

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).

Treatment and study plan

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.

Primary outcomes

  1. copper

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

    the level of copper in blood sample

  2. Iron ion

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

    the level of Iron ion in blood sample

  3. ceruloplasmin, CP

    Time frame: On the 2~4th day of menstruation (amenorrhea patientson the enrolled week)

    the level of ceruloplasmin in blood sample

  4. CuZn-Superoxide Dismutase, CuZn-SOD/SOD1

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

    the level of CuZn-SOD/SOD1 in blood sample

  5. Malondialdehyde,MDA

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

    the level of MDA in blood sample

Secondary outcomes

  1. other relative biomarkers about copper/iron metabolism and oxidative stress

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

    depending on the results of the five biomarkers above

Study contacts

Contact information is provided by the study sponsor or research team.

Ke Xu, Master

CONTACT

[email protected]

18610680372

Yun Shi, PhD

CONTACT

[email protected]

13717926522

Sponsors and collaborators

Lead sponsor

Shi Yun

Other

Registry information

Official study title

Study on the Correlation Between Ovarian Function and Serum Biomarkers

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 24, 2023
Registry last updated
Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.