Examining the link between ovarian function and serum biomarkers
Study on the Correlation Between Ovarian Function and Serum Biomarkers
This study is trying to see how blood markers differ between healthy women and those with ovarian issues to better understand their connection.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 35 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Dongzhimen Hospital, Beijing Academic / other |
| Locations | 1 site (Beijing) |
| Trial ID | NCT06096766 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include women aged 18-45 with either normal ovarian function or diagnosed conditions like diminished ovarian reserve or premature ovarian insufficiency.
Not a fit: Patients with congenital gonadal abnormalities or those who have undergone ovarian surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic tools for assessing ovarian health in women.
How similar studies have performed: While there have been studies on ovarian function and biomarkers, this specific correlation is less explored, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Beijing
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.