NCT06096766 The Correlation Between Ovarian Function and Serum Biomarkers
| NCT ID | NCT06096766 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shi Yun |
| Condition | Premature Ovarian Insufficiency |
| Study Type | OBSERVATIONAL |
| Enrollment | 35 participants |
| Start Date | 2023-10-25 |
| Primary Completion | 2025-11-11 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 35 participants in total. It began in 2023-10-25 with a primary completion date of 2025-11-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this observational study is to find differences in serum biomarkers between ovarian function and normal individuals.
Eligibility 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).
Contact & Investigator
Yun Shi, PhD
STUDY DIRECTOR
Dongzhimen Hospital of Beijing University of Chinese Medicine
Frequently Asked Questions
Who can join the NCT06096766 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 45 Years, studying Premature Ovarian Insufficiency. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06096766 currently recruiting?
Yes, NCT06096766 is actively recruiting participants. Contact the research team at zysyun@163.com for enrollment information.
Where is the NCT06096766 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06096766 clinical trial?
NCT06096766 is sponsored by Shi Yun. The principal investigator is Yun Shi, PhD at Dongzhimen Hospital of Beijing University of Chinese Medicine. The trial plans to enroll 35 participants.