Actively Recruiting
Study on the Correlation Between Ovarian Function and Serum Biomarkers
Led by Shi Yun · Updated on 2024-12-09
35
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating differences in serum biomarkers among women with different ovarian functions, including those with diminished ovarian reserve, premature ovarian insufficiency, and normal ovarian function. This observational study aims to understand how these biomarkers correlate with ovarian health by comparing affected women to those with normal menstruation and hormone levels. The study involves collecting blood samples from women in three groups: those with diminished ovarian reserve, those with premature ovarian insufficiency, and healthy controls with regular menstruation. The blood tests will measure levels of copper ions, iron ions, ceruloplasmin, CuZn superoxide dismutase, and malondialdehyde, among other related biomarkers associated with copper and iron metabolism and oxidative stress. Participants will provide blood samples during the 2nd to 4th day of their menstrual cycle or during the enrolled week for amenorrhea patients. Researchers will analyze these samples to assess the biomarkers and evaluate ovarian function. The study involves informed consent and includes women aged 18 to 45, with some groups having specific hormone level criteria. The trial will continue until November 2025, with data collected to better understand ovarian aging and function.
CONDITIONS
Brief Title
The Correlation Between Ovarian Function and Serum Biomarkers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 18 to 45 years
- Women with regular menstruation and basic FSH less than 10 IU/L and AMH within normal range for healthy group
- Women with diminished ovarian reserve having basal FSH between 10 and 25 IU/L or AMH less than 1.1 ng/ml for two consecutive menstrual cycles
- Women with premature ovarian insufficiency aged less than 40 years with basal FSH greater than 25 IU/L or AMH less than 1.1 ng/ml for two consecutive menstrual cycles
- Agree and sign an informed consent form
You will not qualify if you...
- Patients with congenital gonadal developmental abnormalities or family history of early menopause
- Patients with acquired organic ovarian lesions or decreased ovarian function caused by ovarian surgery
- Patients who have received artificial cycle therapy or endocrine treatments within the past three months
- Patients with severe primary diseases or mental disorders such as cardiovascular, cerebrovascular, liver, kidney, or hematopoietic system diseases
- Patients who are pregnant or breastfeeding
- Patients allergic to drugs used in this study or with allergic history to traditional Chinese medicine
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants provide blood samples to measure serum levels of copper ions, iron ions, ceruloplasmin, CuZn SOD, malondialdehyde, and other related biomarkers.
1 visit (in-person) on the 2nd to 4th day of menstruation or during the enrollment week for amenorrhea patients
Trial Site Locations
Total: 1 location
1
Dongzhimen Hospital, Beijing University of Chinese Medicine
Beijing, China
Actively Recruiting
Research Team
Y
Yun Shi, PhD
K
Ke Xu, Master
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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