The Correlation Between Ovarian Function and Serum Biomarkers
Launched by SHI YUN · Oct 18, 2023
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying how ovarian function relates to certain blood markers in women. The researchers want to understand the differences in these markers between women who have normal ovarian function and those with conditions like Premature Ovarian Insufficiency (POI) or Diminished Ovarian Reserve (DOR). By looking at these differences, they hope to learn more about how aging and other factors might affect ovarian health.
To participate in this study, women aged 18 to 45 who either have normal ovarian function or have been diagnosed with POI or DOR may be eligible, provided they meet specific health criteria. Participants will have their blood tested to measure various markers, and they can expect a supportive environment where their health and well-being are prioritized. It's important to note that women who are pregnant, breastfeeding, or have certain health issues will not be able to join the study. This research could help improve understanding of female reproductive health and lead to better treatments in the future.
Gender
FEMALE
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).
About Shi Yun
Shi Yun is a leading clinical trial sponsor dedicated to advancing medical research and innovation. With a strong focus on developing and optimizing therapeutic solutions, Shi Yun collaborates with healthcare professionals, researchers, and regulatory agencies to conduct high-quality clinical trials. Our commitment to ethical practices, patient safety, and scientific integrity drives our mission to bring groundbreaking treatments to market. Leveraging state-of-the-art technology and a robust network of clinical sites, Shi Yun aims to accelerate the development of novel therapies that address unmet medical needs across diverse therapeutic areas.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Beijing, , China
Patients applied
Trial Officials
Yun Shi, PhD
Study Director
Dongzhimen Hospital of Beijing University of Chinese Medicine
Ke Xu, Master
Principal Investigator
Dongzhimen Hospital of Beijing University of Chinese Medicine
Jing Y Shao, Master
Study Chair
Dongzhimen Hospital of Beijing University of Chinese Medicine
Xuan kai Cai, Master
Study Chair
Shenzhen Bao'an Authentic TCM Therapy Hospital
Qin Y Liu, Bachelor
Study Chair
Dongzhimen Hospital of Beijing University of Chinese Medicine
Xi Y Li, Bachelor
Study Chair
Dongzhimen Hospital of Beijing University of Chinese Medicine
Fei Yan, Master
Study Chair
Dongzhimen Hospital of Beijing University of Chinese Medicine
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported