Examining the link between ovarian function and serum biomarkers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to identify differences in serum biomarkers between women with normal ovarian function and those with conditions like premature ovarian insufficiency and diminished ovarian reserve. Participants will include healthy women and those diagnosed with these conditions, aged 18-45. Blood samples will be collected to measure levels of various biomarkers, including copper ions, ceruloplasmin, and malondialdehyde. The findings may help in understanding the relationship between ovarian function and these serum biomarkers.

Why it matters

Who can join: the full rules

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).

Where it's running

• Dongzhimen Hospital, Beijing University of Chinese Medicine
  Beijing, China Recruiting

Study contacts

• Principal investigator: Ke Xu, Master — Dongzhimen Hospital of Beijing University of Chinese Medicine
• Study coordinator: Yun Shi, PhD
• Email: zysyun@163.com
• Phone: 13717926522

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.