Precise Stratification of Genetic Risk of Ovarian Function Impairment
1 other identifier
observational
1,000
1 country
18
Brief Summary
Aging is a common problem in human society at present. The fertility decline, perimenopausal symptoms and senile diseases caused by ovarian aging seriously affect women's own health, offspring's health, family and social stability, and endanger national population security. Accurate stratification of genetic risk of ovarian aging has practical significance. Early and accurate identification of high-risk groups of premature ovarian aging can help such women to start early protection of ovarian function, preserve fertility to a greater extent, improve fertility quality, and also be conducive to early prevention and treatment of other systemic diseases and prognosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2021
Typical duration for all trials
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2021
CompletedFirst Submitted
Initial submission to the registry
November 30, 2022
CompletedFirst Posted
Study publicly available on registry
December 27, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2024
CompletedDecember 27, 2022
December 1, 2022
2 years
November 30, 2022
December 23, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Genetic variants
Genetic variants that differed significantly between participants and the general population
2 year
Secondary Outcomes (1)
Menopause age
One year after the last menstruation
Study Arms (2)
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)
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.
Interventions
Genetic susceptibility increases the risk of ovarian injury
Eligibility Criteria
A multi regional ovarian aging cohort of Chinese population, including 500 patients with premature ovarian insufficiency, 500 patients with diminished ovarian reserve or early menopause.
You may qualify if:
- Women who meet the diagnosis of premature ovarian insufficiency (POI), diminished ovarian reserve (DOR) or early menopause and hope to find out the risk of premature ovarian impairment and clarify the cause of premature ovarian impairment;
- 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.
- 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.
- Early menopause: women who enter menopause between the age of 40 and 45.
- Informed consent, voluntary test.
You may not qualify if:
- Chromosome karyotype abnormality;
- Iatrogenic ovarian injury: history of radiotherapy, chemotherapy (reproductive toxic drugs such as alkylating agents) and ovarian surgery;
- Ovarian mass: there is abnormal echo in the ovary under ultrasound, and the maximum diameter is greater than 4cm.
- Pregnant and lactating women;
- Polycystic ovary syndrome, hyperprolactinemia, hyperandrogenemia, hypothyroidism, adrenal dysfunction and other endocrine diseases affect ovulation;
- Patients with cardiovascular, liver, kidney, hematopoietic system and other serious primary diseases and psychosis;
- Patients who are participating in other clinical trials or have participated in other clinical trials in the past month;
- Other patients determined by the investigator to be unsuitable for participation in this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tongji Hospitallead
Study Sites (18)
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, 430000, 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
Related Publications (1)
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.
PMID: 40089715DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Shixuan Wang, Doctor
Tongji Hospital, Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professsor
Study Record Dates
First Submitted
November 30, 2022
First Posted
December 27, 2022
Study Start
November 1, 2021
Primary Completion
October 31, 2023
Study Completion
October 31, 2024
Last Updated
December 27, 2022
Record last verified: 2022-12