Precise Stratification of Genetic Risk of Ovarian Function Impairment

Tongji Hospital

Status: Enrolling

Conditions: Diminished Ovarian Reserve; Early Menopause; Premature Ovarian Insufficiency

Treatments: Other: Genetic susceptibility

Study type: Observational

Funder types: Other

Identifiers

NCT05665010

TJ-IRB20211016-SOA

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

1,000 participants in 2 patient groups

premature ovarian insufficiency

Description:

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)

Treatment:

Other: Genetic susceptibility

declined ovarian function

Description:

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.

Treatment:

Other: Genetic susceptibility