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Search / Trial NCT06096766

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.

Locations

Beijing, , China

Patients applied

0 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