Clinical trial NCT05665010: Precise Stratification of Genetic Risk of Ovarian Function Impairment
Official title: Precise Stratification of Genetic Risk of Ovarian Function Impairment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Premature Ovarian Insufficiency
Diminished Ovarian Reserve
Early Menopause
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2022-12-27
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility criteria: Inclusion Criteria:

1. 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;

   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:

1. Chromosome karyotype abnormality;
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.

Primary outcomes:
measure: Genetic variants
timeFrame: 2 year
Secondary outcomes:
measure: Menopause age
timeFrame: One year after the last menstruation
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian maternal and Child Health Hospital
state: Fujian
city: Guangzhou
country: China
facility: Guangdong maternal and Child Health Hospital
state: Guangdong
city: Guanzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
city: Shijiazhuang
country: China
facility: Shijiazhuang maternity hospital
state: Hebei
city: Zhengzhou
country: China
facility: The Third Affiliated Hospital of Zhengzhou University
state: Henan
city: Wuhan
country: China
facility: Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of science and technology
state: Hubei
city: Wuhan
country: China
facility: Central South Hospital of Wuhan University
state: Hubei
city: Wuhan
country: China
facility: Hubei maternal and Child Health Hospital
state: Hubei
city: Wuhan
country: China
facility: Liyuan Hospital Affiliated to Tongji Medical College of Huazhong University of science and technology
state: Hubei
city: Wuhan
country: China
facility: People's Hospital of Wuhan University
state: Hubei
city: Xiangyang
country: China
facility: Xiangyang Central Hospital
state: Hubei
city: Changsha
country: China
facility: Changsha maternal and Child Health Hospital
state: Hunan
city: Suzhou
country: China
facility: The First Affiliated Hospital of Suzhou University
state: Jiangsu
city: Nanchang
country: China
facility: Jiangxi maternal and Child Health Hospital
state: Jiangxi
city: Xi'an
country: China
facility: Northwest women and children's Hospital
state: Shanxi
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shanxi
city: Kunming
country: China
facility: Affiliated Hospital of Yunnan University
state: Yunnan
city: Hangzhou
country: China
facility: Hospital of Obstetrics and Gynecology affiliated to Medical College of Zhejiang University
state: Zhejiang
Study officials:
affiliation: Tongji Hospital, Affiliated to Tongji Medical College of Huazhong University of Science and Technology
name: Shixuan Wang, Doctor
role: STUDY_CHAIR
References: