Precise Stratification of Genetic Risk of Ovarian Function Impairment
NCT ID: NCT05665010
Last Updated: 2022-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
1000 participants
OBSERVATIONAL
2021-11-01
2024-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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premature ovarian insufficiency
Patients with premature ovarian insufficiency (female age \<40 years, menopause or menstrual rarity for 4 months, basal FSH \> 25 IU / L for two consecutive intervals of more than 4 weeks)
Genetic susceptibility
Genetic susceptibility increases the risk of ovarian injury
declined ovarian function
Patients with diminished ovarian reserve(women before 40 years old; the number of antral follicles in both ovaries is less than 6, AMH \< 1.1ng/ml, and basal FSH \> 10 IU / L, which meets one of the three requirements)；Female with menopause between the age of 40 and 45.
Genetic susceptibility
Genetic susceptibility increases the risk of ovarian injury
Interventions
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Genetic susceptibility
Genetic susceptibility increases the risk of ovarian injury
Eligibility Criteria
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Inclusion Criteria
1. premature ovarian insufficiency (POI): the age of female is less than 40 years old, with menopause or sparse menstruation for 4 months, and basal FSH \> 25IU / L for two consecutive times with an interval of more than 4 weeks.
2. Diminshed ovarian reserve (DOR): before the age of 40, the number of antral follicles in both ovaries is less than 6, or AMH is less than 1.1ng/ml, or basal FSH is greater than 10 IU/L.
3. Early menopause: women who enter menopause between the age of 40 and 45.
2. Informed consent, voluntary test.
Exclusion Criteria
2. Iatrogenic ovarian injury: history of radiotherapy, chemotherapy (reproductive toxic drugs such as alkylating agents) and ovarian surgery;
3. Ovarian mass: there is abnormal echo in the ovary under ultrasound, and the maximum diameter is greater than 4cm.
4. Pregnant and lactating women;
5. Polycystic ovary syndrome, hyperprolactinemia, hyperandrogenemia, hypothyroidism, adrenal dysfunction and other endocrine diseases affect ovulation;
6. Patients with cardiovascular, liver, kidney, hematopoietic system and other serious primary diseases and psychosis;
7. Patients who are participating in other clinical trials or have participated in other clinical trials in the past month;
8. Other patients determined by the investigator to be unsuitable for participation in this study.
18 Years
40 Years
FEMALE
No
Sponsors
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Tongji Hospital
OTHER
Responsible Party
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Shixuan Wang
Professsor
Principal Investigators
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Shixuan Wang, Doctor
Role: STUDY_CHAIR
Tongji Hospital, Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Locations
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Fujian maternal and Child Health Hospital
Fuzhou, Fujian, China
Guangdong maternal and Child Health Hospital
Guangzhou, Guangdong, China
Guangdong Provincial People's Hospital
Guanzhou, Guangdong, China
Shijiazhuang maternity hospital
Shijiazhuang, Hebei, China
The Third Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of science and technology
Wuhan, Hubei, China
Central South Hospital of Wuhan University
Wuhan, Hubei, China
Hubei maternal and Child Health Hospital
Wuhan, Hubei, China
Liyuan Hospital Affiliated to Tongji Medical College of Huazhong University of science and technology
Wuhan, Hubei, China
People's Hospital of Wuhan University
Wuhan, Hubei, China
Xiangyang Central Hospital
Xiangyang, Hubei, China
Changsha maternal and Child Health Hospital
Changsha, Hunan, China
The First Affiliated Hospital of Suzhou University
Suzhou, Jiangsu, China
Jiangxi maternal and Child Health Hospital
Nanchang, Jiangxi, China
Northwest women and children's Hospital
Xi’an, Shanxi, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China
Affiliated Hospital of Yunnan University
Kunming, Yunnan, China
Hospital of Obstetrics and Gynecology affiliated to Medical College of Zhejiang University
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Lili Chen
Role: primary
Wenqing Ma, Doctor
Role: primary
Jie Duan
Role: primary
Xin Li
Role: primary
Min Liu
Role: primary
Guanghua Chu
Role: primary
Yuanyuan Li, Doctor
Role: primary
References
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Ma W, Ye S, Tian L, Liu M, Wang R, Yang X, Wang M, Fu F, Ren W, Dang L, Wang T, Wang W, Wang S, Sun Y, Li Y. Association of LHCGR rs2293275 genotype with ovarian aging in Chinese women: a multicenter population-based study. Reprod Biol Endocrinol. 2025 Mar 15;23(1):41. doi: 10.1186/s12958-025-01375-2.
Other Identifiers
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TJ-IRB20211016-SOA
Identifier Type: -
Identifier Source: org_study_id