Menu
Recruiting NCT06096766

The Correlation Between Ovarian Function and Serum Biomarkers

— Observational Premature Ovarian Insufficiency Diminished Ovarian Reserve Biomarker Copper

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: blood test.
Who it may be relevant to
Registry conditions: Premature Ovarian Insufficiency, Diminished Ovarian Reserve, Biomarker, Copper. Basic parameters: 18 years — 45 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Study on the Correlation Between Ovarian Function and Serum Biomarkers

Overview

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 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.

Primary outcome measures

  • copper [Time frame: On the 2~4th day of menstruation (amenorrhea patients on the enrolled week)]
  • Iron ion [Time frame: On the 2~4th day of menstruation (amenorrhea patients on the enrolled week)]
  • ceruloplasmin, CP [Time frame: On the 2~4th day of menstruation (amenorrhea patientson the enrolled week)]
  • CuZn-Superoxide Dismutase, CuZn-SOD/SOD1 [Time frame: On the 2~4th day of menstruation (amenorrhea patients on the enrolled week)]
  • Malondialdehyde，MDA [Time frame: On the 2~4th day of menstruation (amenorrhea patients on the enrolled week)]
Secondary outcome measures (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)]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Dongzhimen Hospital, Beijing University of Chinese Medicine — Beijing

Identifiers

NCT: NCT06096766 · 2023DZMEC-489

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗