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Precise Stratification of Genetic Risk of Ovarian Function Impairment

Precise Stratification of Genetic Risk of Ovarian Function Impairment

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05665010
Enrollment
1000
Registered
2022-12-27
Start date
2021-11-01
Completion date
2024-10-31
Last updated
2022-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diminished Ovarian Reserve, Early Menopause, Premature Ovarian Insufficiency

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.

Interventions

OTHERGenetic susceptibility

Genetic susceptibility increases the risk of ovarian injury

Sponsors

Tongji Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Genetic variants2 yearGenetic variants that differed significantly between participants and the general population

Secondary

MeasureTime frameDescription
Menopause ageOne year after the last menstruationMenopause for more than one year

Countries

China

Contacts

Primary ContactWenqing Ma, Doctor
wenqing.ma@hotmail.com02783663698

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026