Precise Stratification of Genetic Risk of Ovarian Function Impairment

Recruiting

• Conditions: Early Menopause; Diminished Ovarian Reserve; Premature Ovarian Insufficiency
• Interventions: Other: Genetic susceptibility

• Registration Number: NCT05665010
• Lead Sponsor: Tongji Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-01
• Study First Submitted: 2022-11-30
• Status Verified: 2022-12
• Study First Submitted QC: 2022-12-23
• Last Update Submitted: 2022-12-23
• Study First Posted: 2022-12-27
• Last Update Posted: 2022-12-27
• Primary Completion: 2023-10-31
• Study Completion: 2024-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 1000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
premature ovarian insufficiency	Genetic susceptibility	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	Genetic susceptibility	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.

Primary Outcome Measures

Name	Time	Method
Genetic variants	2 year	Genetic variants that differed significantly between participants and the general population

Secondary Outcome Measures

Name	Time	Method
Menopause age	One year after the last menstruation	Menopause for more than one year

Trial Locations

Locations (18)

Guangdong Provincial People's Hospital; 🇨🇳 Guanzhou, Guangdong, China

Guangdong maternal and Child Health Hospital; 🇨🇳 Guangzhou, Guangdong, China

Shijiazhuang maternity hospital; 🇨🇳 Shijiazhuang, Hebei, China

The Third Affiliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, Henan, China

Affiliated Hospital of Yunnan University; 🇨🇳 Kunming, Yunnan, 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

Fujian maternal and Child Health Hospital; 🇨🇳 Fuzhou, Fujian, China

Central South Hospital of Wuhan University; 🇨🇳 Wuhan, Hubei, China

Hubei maternal and Child Health Hospital; 🇨🇳 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

The First Affiliated Hospital of Xi'an Jiaotong University; 🇨🇳 Xi'an, Shanxi, China

Hospital of Obstetrics and Gynecology affiliated to Medical College of Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China

Liyuan Hospital Affiliated to Tongji Medical College of Huazhong University of science and technology; 🇨🇳 Wuhan, Hubei, China