Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05665010
Other study ID # TJ-IRB20211016-SOA
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 1, 2021
Est. completion date October 31, 2024

Study information

Verified date December 2022
Source Tongji Hospital
Contact Wenqing Ma, Doctor
Phone 02783663698
Email wenqing.ma@hotmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date October 31, 2024
Est. primary completion date October 31, 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 40 Years
Eligibility 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


Intervention

Other:
Genetic susceptibility
Genetic susceptibility increases the risk of ovarian injury

Locations

Country Name City State
China Changsha maternal and Child Health Hospital Changsha Hunan
China Fujian maternal and Child Health Hospital Fuzhou Fujian
China Guangdong maternal and Child Health Hospital Guangzhou Guangdong
China Guangdong Provincial People's Hospital Guanzhou Guangdong
China Hospital of Obstetrics and Gynecology affiliated to Medical College of Zhejiang University Hangzhou Zhejiang
China Affiliated Hospital of Yunnan University Kunming Yunnan
China Jiangxi maternal and Child Health Hospital Nanchang Jiangxi
China Shijiazhuang maternity hospital Shijiazhuang Hebei
China The First Affiliated Hospital of Suzhou University Suzhou Jiangsu
China Central South Hospital of Wuhan University Wuhan Hubei
China Hubei maternal and Child Health Hospital Wuhan Hubei
China Liyuan Hospital Affiliated to Tongji Medical College of Huazhong University of science and technology Wuhan Hubei
China People's Hospital of Wuhan University Wuhan Hubei
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 The First Affiliated Hospital of Xi'an Jiaotong University Xi'an Shanxi
China Xiangyang Central Hospital Xiangyang Hubei
China The Third Affiliated Hospital of Zhengzhou University Zhengzhou Henan

Sponsors (1)

Lead Sponsor Collaborator
Tongji Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Genetic variants Genetic variants that differed significantly between participants and the general population 2 year
Secondary Menopause age Menopause for more than one year One year after the last menstruation
See also
  Status Clinical Trial Phase
Recruiting NCT04972877 - Effect of Electro-acupuncture on Women With Diminished Ovarian Reserve N/A
Recruiting NCT04447872 - The LUTEAL Trial: Luteal Stimulation vs. Estrogen Priming Protocol N/A
Recruiting NCT05277948 - Effect of Thumbtack Needle on Ovarian Function of Women With Diminished Ovarian Reserve (DOR) N/A
Recruiting NCT04711772 - Whole-genome Sequencing Study in Patients With Diminished Ovarian Reserve
Recruiting NCT03670407 - Follicular Activation by Fragmentation of Ovarian Tissue N/A
Recruiting NCT06072794 - A Proof of Concept Study to Evaluate Exosomes From Human Mesenchymal Stem Cells in Women With Premature Ovarian Insufficiency (POI) Phase 1
Recruiting NCT06096766 - the Correlation Between Ovarian Function and Serum Biomarkers
Not yet recruiting NCT02099916 - Administration of DHEA in Patients With Poor Response to Ovarian Stimulation for IVF Phase 2/Phase 3
Not yet recruiting NCT06081257 - The Effect of "KB-120" Small Molecular Nutrient in Women With Decreased Ovarian Reserve N/A
Recruiting NCT06426355 - The Effeciency of NMN in Improving IVF/ICSI-ET Pregnancy Outcomes in Patients With DOR N/A
Recruiting NCT04275700 - Study of PRP in Women With Evidence of Diminished Ovarian Reserve N/A
Recruiting NCT06223178 - Efficacy of Thumb-tack Needle Treatment for Diminished Ovarian Reserve N/A
Not yet recruiting NCT05577455 - Efficacy of Traditional Chinese Medicine on Ameliorating IVF-ET Outcomes of Diminished Ovarian Reserve Patients Phase 3
Not yet recruiting NCT05459493 - A Clinical Study of Chinese Herbal Compound TJAOA101 in Therapy of Diminished Ovarian Reserve Early Phase 1
Not yet recruiting NCT05385848 - Autologous Platelet-rich Plasma (PRP) Infusion to Improve Outcomes in Women With Ovarian Insufficiency: a Pilot Study N/A
Terminated NCT01614067 - Delayed Start to Ovarian Stimulation Phase 4
Recruiting NCT06395623 - Study of Acupoints in Diminished Ovarian Reserve Based on Biological Characteristics
Recruiting NCT05847283 - DPOS Versus GnRH Antagonist Protocol for Oocyte Accumulation in Low Ovarian Reserve Patients: An RCT N/A
Recruiting NCT05485610 - Effect of NMN (Nicotinamide Mononucleotide) on Diminished Ovarian Reserve (Including Premature Ovarian Insufficiency) N/A
Completed NCT04237909 - Effects of Intraovarian Platelet Rich Plasma in Women With Poor Ovarian Response and Premature Ovarian Insufficiency N/A