Premature Ovarian InsufficiencyNCT05665010
Precise Stratification of Genetic Risk of Ovarian Function Impairment
An observational study of Premature Ovarian Insufficiency and Diminished Ovarian Reserve, run by Tongji Hospital at 18 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Premature Ovarian Insufficiency, Diminished Ovarian Reserve, Early Menopause
- What is being tested?
- Genetic susceptibility
- How many people
- 1,000 participants
- Where
- 18 sitesChina
- Study dates
- 1 Nov 2021to 31 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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;
- 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.
- 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.
- Early menopause: women who enter menopause between the age of 40 and 45.
- Informed consent, voluntary test.
Who cannot join
- Chromosome karyotype abnormality;
- Iatrogenic ovarian injury: history of radiotherapy, chemotherapy (reproductive toxic drugs such as alkylating agents) and ovarian surgery;
- Ovarian mass: there is abnormal echo in the ovary under ultrasound, and the maximum diameter is greater than 4cm.
- Pregnant and lactating women;
- Polycystic ovary syndrome, hyperprolactinemia, hyperandrogenemia, hypothyroidism, adrenal dysfunction and other endocrine diseases affect ovulation;
- Patients with cardiovascular, liver, kidney, hematopoietic system and other serious primary diseases and psychosis;
- Patients who are participating in other clinical trials or have participated in other clinical trials in the past month;
- Other patients determined by the investigator to be unsuitable for participation in this study.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
China18 sites, 7 recruiting
- Recruiting
Changsha maternal and Child Health Hospital
Changsha, Hunan
Min Liu
- Recruiting
Fujian maternal and Child Health Hospital
Fuzhou, Fujian
Lili Chen
- Active, not recruiting
Guangdong maternal and Child Health Hospital
Guangzhou, Guangdong
- Active, not recruiting
Guangdong Provincial People's Hospital
Guanzhou, Guangdong
- Active, not recruiting
Hospital of Obstetrics and Gynecology affiliated to Medical College of Zhejiang University
Hangzhou, Zhejiang
- Recruiting
Affiliated Hospital of Yunnan University
Kunming, Yunnan
Yuanyuan Li, Doctor
- Active, not recruiting
Jiangxi maternal and Child Health Hospital
Nanchang, Jiangxi
- Active, not recruiting
Shijiazhuang maternity hospital
Shijiazhuang, Hebei
- Active, not recruiting
The First Affiliated Hospital of Suzhou University
Suzhou, Jiangsu
- Recruiting
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of science and technology
Wuhan, Hubei, 430000
Wenqing Ma, Doctor
- Active, not recruiting
Central South Hospital of Wuhan University
Wuhan, Hubei
- Recruiting
Hubei maternal and Child Health Hospital
Wuhan, Hubei
Jie Duan
- Active, not recruiting
Liyuan Hospital Affiliated to Tongji Medical College of Huazhong University of science and technology
Wuhan, Hubei
- Recruiting
People's Hospital of Wuhan University
Wuhan, Hubei
Xin Li
- Recruiting
Northwest women and children's Hospital
Xi’an, Shanxi
Guanghua Chu
- Active, not recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi
- Active, not recruiting
Xiangyang Central Hospital
Xiangyang, Hubei
- Active, not recruiting
The Third Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
About this study
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.
- Being tested
- Genetic susceptibility
- Medical subject headings
- Primary Ovarian Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genetic susceptibilityOther
Genetic susceptibility increases the risk of ovarian injury
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: Genetic susceptibility | |
| 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. Receives: Other: Genetic susceptibility |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genetic variants
Genetic variants that differed significantly between participants and the general population
Measured: 2 year
Secondary outcomes (1)
Menopause age
Menopause for more than one year
Measured: One year after the last menstruation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2022
- Study start1 Nov 2021
- Primary completion31 Oct 2023 (estimated)
- Study completion31 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Premature Ovarian InsufficiencyStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shixuan Wang, Tongji Hospital
- Investigators
- Shixuan Wang, Doctor, Study chair, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05665010
- Sponsor's protocol ID
- TJ-IRB20211016-SOA
- Status last verified
- Dec 2022
- First submitted
- 30 Nov 2022
- Last updated
- 27 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ma W, Ye S, Tian L, Liu M, Wang R, Yang X, Wang M, Fu F, Ren W, Dang L, Wang T, Wang W, Wang S, Sun Y, Li Y. Association of LHCGR rs2293275 genotype with ovarian aging in Chinese women: a multicenter population-based study. Reprod Biol Endocrinol. 2025 Mar 15;23(1):41. doi: 10.1186/s12958-025-01375-2.
PubMed 40089715
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precise Stratification of Genetic Risk of Ovarian Function Impairment
- ClinicalTrials.gov ID
- NCT05665010
- Acronym / sponsor ID
- TJ-IRB20211016-SOA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 27 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| premature ovarian insufficiency | – | Other: Genetic susceptibilityPatients 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) |
| declined ovarian function | – | Other: Genetic susceptibilityPatients 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- 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;
- Informed consent, voluntary test.
Key exclusion criteria (8 listed)
- Chromosome karyotype abnormality;
- Iatrogenic ovarian injury: history of radiotherapy, chemotherapy (reproductive toxic drugs such as alkylating agents) and ovarian surgery;
- Ovarian mass: there is abnormal echo in the ovary under ultrasound, and the maximum diameter is greater than 4cm.
- Pregnant and lactating women;
- Polycystic ovary syndrome, hyperprolactinemia, hyperandrogenemia, hypothyroidism, adrenal dysfunction and other endocrine diseases affect ovulation;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Genetic susceptibilityGenetic susceptibility increases the risk of ovarian injury | Other | declined ovarian function, premature ovarian insufficiency |
Primary outcome
Genetic variants
Time frame: 2 year
Genetic variants that differed significantly between participants and the general population
1 secondary outcome
Menopause age
Time frame: One year after the last menstruation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2022.
- Derived from this study: PubMed 40089715Ma W, Ye S, Tian L, Liu M, Wang R, Yang X, Wang M, Fu F, Ren W, Dang L, Wang T, Wang W, Wang S, Sun Y, Li Y. Association of LHCGR rs2293275 genotype with ovarian aging in Chinese women: a multicenter population-based study. Reprod Biol Endocrinol. 2025 Mar 15;23(1):41. doi: 10.1186/s12958-025-01375-2.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shixuan Wang, Doctor study chair
Tongji Hospital
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Premature Ovarian Insufficiency and Diminished Ovarian Reserve, run by Tongji Hospital at 18 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wenqing Ma, Doctor (02783663698, wenqing.ma@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genetic variants (time frame: 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05665010, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2022.