Precise Stratification of Genetic Risk of Ovarian Function Impairment

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.

Study Overview

• Status: Recruiting
• Conditions: Diminished Ovarian Reserve; Premature Ovarian Insufficiency; Early Menopause
• Intervention / Treatment: Other: Genetic susceptibility

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Wenqing Ma, Doctor; Phone Number: 02783663698; Email: wenqing.ma@hotmail.com

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China
      • Recruiting
      • Fujian Maternal and Child Health Hospital
  • Guangdong
    • Guangzhou, Guangdong, China
      • Active, not recruiting
      • Guangdong Maternal and Child Health Hospital
    • Guanzhou, Guangdong, China
      • Active, not recruiting
      • Guangdong Provincial People's Hospital
  • Hebei
    • Shijiazhuang, Hebei, China
      • Active, not recruiting
      • Shijiazhuang maternity hospital
  • Henan
    • Zhengzhou, Henan, China
      • Active, not recruiting
      • The Third Affiliated Hospital of Zhengzhou University
  • Hubei
    • Wuhan, Hubei, China, 430000
      • Recruiting
      • Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
      • Contact: Wenqing Ma, Doctor
    • Wuhan, Hubei, China
      • Active, not recruiting
      • Central South Hospital of Wuhan University
    • Wuhan, Hubei, China
      • Recruiting
      • Hubei Maternal and Child Health Hospital
      • Contact: Jie Duan
    • Wuhan, Hubei, China
      • Active, not recruiting
      • Liyuan Hospital Affiliated to Tongji Medical College of Huazhong University of science and technology
    • Wuhan, Hubei, China
      • Recruiting
      • People's Hospital of Wuhan University
      • Contact: Xin Li
    • Xiangyang, Hubei, China
      • Active, not recruiting
      • Xiangyang Central Hospital
  • Hunan
    • Changsha, Hunan, China
      • Recruiting
      • Changsha maternal and Child Health Hospital
      • Contact: Min Liu
  • Jiangsu
    • Suzhou, Jiangsu, China
      • Active, not recruiting
      • The first affiliated hospital of suzhou University
  • Jiangxi
    • Nanchang, Jiangxi, China
      • Active, not recruiting
      • Jiangxi Maternal and Child Health Hospital
  • Shanxi
    • Xi'an, Shanxi, China
      • Recruiting
      • Northwest Women and Children's Hospital
      • Contact: Guanghua Chu
    • Xi'an, Shanxi, China
      • Active, not recruiting
      • The First Affiliated Hospital of Xi'An JiaoTong University
  • Yunnan
    • Kunming, Yunnan, China
      • Recruiting
      • Affiliated Hospital of Yunnan University
      • Contact: Yuanyuan Li, Doctor
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Active, not recruiting
      • Hospital of Obstetrics and Gynecology affiliated to Medical College of Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

A multi regional ovarian aging cohort of Chinese population, including 500 patients with premature ovarian insufficiency, 500 patients with diminished ovarian reserve or early menopause.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
premature ovarian insufficiency; 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)	Other: Genetic susceptibility; Genetic susceptibility increases the risk of ovarian injury
declined ovarian function; 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.	Other: Genetic susceptibility; Genetic susceptibility increases the risk of ovarian injury

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Genetic variants	Genetic variants that differed significantly between participants and the general population	2 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Menopause age	Menopause for more than one year	One year after the last menstruation

Collaborators and Investigators

• Sponsor: Tongji Hospital
• Investigators: Study Chair: Shixuan Wang, Doctor, Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Anticipated): October 31, 2023
• Study Completion (Anticipated): October 31, 2024

Study Registration Dates

• First Submitted: November 30, 2022
• First Submitted That Met QC Criteria: December 23, 2022
• First Posted (Actual): December 27, 2022

Study Record Updates

• Last Update Posted (Actual): December 27, 2022
• Last Update Submitted That Met QC Criteria: December 23, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Primary Ovarian Insufficiency; Menopause, Premature
• Other Study ID Numbers: TJ-IRB20211016-SOA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No