Precise Stratification of Genetic Risk of Ovarian Function Impairment

Diminished Ovarian Reserve Clinical Trial

Official title:

Precise Stratification of Genetic Risk of Ovarian Function Impairment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05665010
• Other study ID #: TJ-IRB20211016-SOA
• Status: Recruiting
• Start date: November 1, 2021
• Est. completion date: October 31, 2024

Study information

• Verified date: December 2022
• Source: Tongji Hospital
• Contact: Wenqing Ma, Doctor
• Phone: 02783663698
• Email: wenqing.ma[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: October 31, 2024
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diminished Ovarian Reserve
• Early Menopause
• Menopause, Premature
• Premature Ovarian Insufficiency
• Primary Ovarian Insufficiency

Intervention

Other:
• Genetic susceptibility
Genetic susceptibility increases the risk of ovarian injury

Locations

Country	Name	City	State
China	Changsha maternal and Child Health Hospital	Changsha	Hunan
China	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	Hospital of Obstetrics and Gynecology affiliated to Medical College of Zhejiang University	Hangzhou	Zhejiang
China	Affiliated Hospital of Yunnan University	Kunming	Yunnan
China	Jiangxi maternal and Child Health Hospital	Nanchang	Jiangxi
China	Shijiazhuang maternity hospital	Shijiazhuang	Hebei
China	The First Affiliated Hospital of Suzhou University	Suzhou	Jiangsu
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	Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of science and technology	Wuhan	Hubei
China	Northwest women and children's Hospital	Xi'an	Shanxi
China	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shanxi
China	Xiangyang Central Hospital	Xiangyang	Hubei
China	The Third Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Tongji Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Genetic variants	Genetic variants that differed significantly between participants and the general population	2 year
Secondary	Menopause age	Menopause for more than one year	One year after the last menstruation