Precise Stratification of Genetic Risk of Ovarian Function Impairment

Last updated: December 23, 2022
Sponsor: Tongji Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Post Menopause

Perimenopause

Treatment

N/A

Clinical Study ID

NCT05665010
TJ-IRB20211016-SOA
  • Ages 18-40
  • Female

Study 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

Inclusion Criteria:

  1. Women who meet the diagnosis of premature ovarian insufficiency (POI), diminishedovarian reserve (DOR) or early menopause and hope to find out the risk of prematureovarian impairment and clarify the cause of premature ovarian impairment;
  2. premature ovarian insufficiency (POI): the age of female is less than 40 yearsold, with menopause or sparse menstruation for 4 months, and basal FSH > 25IU / Lfor two consecutive times with an interval of more than 4 weeks.
  3. Diminshed ovarian reserve (DOR): before the age of 40, the number of antralfollicles in both ovaries is less than 6, or AMH is less than 1.1ng/ml, or basalFSH is greater than 10 IU/L.
  4. Early menopause: women who enter menopause between the age of 40 and 45.
  5. Informed consent, voluntary test.

Exclusion

Exclusion Criteria:

  1. Chromosome karyotype abnormality;
  2. Iatrogenic ovarian injury: history of radiotherapy, chemotherapy (reproductive toxicdrugs such as alkylating agents) and ovarian surgery;
  3. Ovarian mass: there is abnormal echo in the ovary under ultrasound, and the maximumdiameter 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 seriousprimary diseases and psychosis;
  7. Patients who are participating in other clinical trials or have participated in otherclinical trials in the past month;
  8. Other patients determined by the investigator to be unsuitable for participation inthis study.

Study Design

Total Participants: 1000
Study Start date:
November 01, 2021
Estimated Completion Date:
October 31, 2024

Connect with a study center

  • Fujian maternal and Child Health Hospital

    Fuzhou, Fujian
    China

    Active - Recruiting

  • Guangdong maternal and Child Health Hospital

    Guangzhou, Guangdong
    China

    Site Not Available

  • Guangdong Provincial People's Hospital

    Guanzhou, Guangdong
    China

    Site Not Available

  • Shijiazhuang maternity hospital

    Shijiazhuang, Hebei
    China

    Site Not Available

  • The Third Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan
    China

    Site Not Available

  • Central South Hospital of Wuhan University

    Wuhan, Hubei
    China

    Site Not Available

  • Hubei maternal and Child Health Hospital

    Wuhan, Hubei
    China

    Active - Recruiting

  • Liyuan Hospital Affiliated to Tongji Medical College of Huazhong University of science and technology

    Wuhan, Hubei
    China

    Site Not Available

  • People's Hospital of Wuhan University

    Wuhan, Hubei
    China

    Active - Recruiting

  • Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of science and technology

    Wuhan, Hubei 430000
    China

    Active - Recruiting

  • Xiangyang Central Hospital

    Xiangyang, Hubei
    China

    Site Not Available

  • Changsha maternal and Child Health Hospital

    Changsha, Hunan
    China

    Active - Recruiting

  • The First Affiliated Hospital of Suzhou University

    Suzhou, Jiangsu
    China

    Site Not Available

  • Jiangxi maternal and Child Health Hospital

    Nanchang, Jiangxi
    China

    Site Not Available

  • Northwest women and children's Hospital

    Xi'an, Shanxi
    China

    Active - Recruiting

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shanxi
    China

    Site Not Available

  • Affiliated Hospital of Yunnan University

    Kunming, Yunnan
    China

    Active - Recruiting

  • Hospital of Obstetrics and Gynecology affiliated to Medical College of Zhejiang University

    Hangzhou, Zhejiang
    China

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.