Actively Recruiting
A Multicenter Observational Study on the Development and Health Effects of Premature Ovarian Insufficiency
Led by Women's Hospital School Of Medicine Zhejiang University · Updated on 2026-05-28
1080
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Premature ovarian insufficiency (POI) occurs when ovarian function declines in women before age 40, significantly affecting health and quality of life. This research aims to better understand the causes, progression, and health impacts of POI, as well as evaluate hormone replacement therapy (HRT) options. The study will create a hospital-based, multi-center case-control and prospective cohort to gather comprehensive data on POI's natural course and effects. The study includes several groups: women diagnosed with POI, control women with regular menstrual cycles, those scheduled for ovarian surgery, and those undergoing oophorectomy. Participants provide biological samples, lifestyle and health information, and undergo long-term follow-up assessments. Data collection spans multiple health factors including reproductive hormones, bone density, psychological well-being, and metabolic markers. Participants will be monitored at regular intervals up to 36 months with tests such as bone density scans, hormone level checks, blood glucose and insulin measurements, and psychological assessments for anxiety and depression. The study also tracks symptoms related to low estrogen and sexual health. Safety and health outcomes are observed through blood counts, liver and kidney function tests, and ultrasound exams. This comprehensive approach aims to deepen understanding and support improved care for women with POI.
CONDITIONS
Brief Title
A Multicenter Observational Study on the Development and Health Effects of Premature Ovarian Insufficiency
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women diagnosed with premature ovarian insufficiency before age 40, meeting specific diagnostic criteria
- Women aged 18 to 50 with regular menstrual cycles (21-35 days) for the past 12 months for control group
- Women aged 18 to 60 scheduled for ovarian surgery for gynecological disease
- Women aged 45 to 65 scheduled for oophorectomy due to gynecological diseases and menopausal status
- Willingness to participate, provide biological samples, and complete long-term follow-up assessments or provide informed consent
You will not qualify if you...
- Current pregnancy or breastfeeding
- Severe systemic diseases such as active malignancy unrelated to POI, severe heart or kidney failure, cognitive impairment
- History of reproductive disorders like PCOS, endometriosis, or other reproductive pathologies
- Prior ovarian surgery, chemotherapy, or radiotherapy for control group
- History of endocrine, autoimmune, cardiovascular, liver, kidney, hematological diseases, or malignancy
- Genetic or chromosomal abnormalities such as Turner syndrome or other genetic diseases
- Use of hormonal drugs or contraceptives within the last 6 months
- Women seeking assisted reproductive technology
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 - Up to 36 months
Participants provide biological samples and complete assessments to monitor health effects and development of premature ovarian insufficiency over time.
Visits at baseline, 6 months, 12 months, 24 months, and 36 months
Trial Site Locations
Total: 2 locations
1
Women's Hospital School of Medicine Zhejiang University
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
2
Women's Hospital School of Medicine Zhejiang University
Hangzhou, Zhejiang, China, 310000
Not Yet Recruiting
Research Team
J
Jianhong Zhou, Doctor of Medicine(M.D.)
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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