Premature Ovarian InsufficiencyNCT06096766
The Correlation Between Ovarian Function and Serum Biomarkers
An observational study of Premature Ovarian Insufficiency and Diminished Ovarian Reserve, run by Shi Yun at 1 site in China.
Trial summary
The goal of this observational study is to find differences in serum biomarkers between ovarian function and normal individuals. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Premature Ovarian Insufficiency, Diminished Ovarian Reserve, Biomarker
- What is being tested?
- blood test
- How many people
- 35 participants
- Where
- 1 siteChina
- Study dates
- 25 Oct 2023to 11 Nov 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Visited the gynecology clinic of Dongzhimen Hospital from November 2023 to October 2024. Upon examination of sexual hormones or AMH, it was considered that patients with Diminished Ovarian Reserve (DOR), premature ovarian insufficiency (POI), and healthy individuals had decreased ovarian reserve function.
Who may be able to join
- The selection criteria for healthy individuals are follows.
- women aged 18-45.
- Basic FSH<10IU/L, and AMH is within the normal range.
- Regular menstruation.
- Agree and sign an informed consent form.
- The selection criteria for DOR patients are follows.
Show all 13Show fewer
- women aged 18-45.
- For two consecutive menstrual cycles, 25 ≥ basal FSH ≥ 10IU/L or AMH<1.1ng/ml.
- Agree and sign an informed consent form.
- Selection criteria for POI patients are follows.
- 18 ≤ females aged <40 years old.
- Two consecutive menstrual cycles with basal FSH>25IU/L or AMH<1.1ng/ml.
- Agree and sign an informed consent form.
Who cannot join
- Patients with congenital gonadal developmental abnormalities or a family history similar to "early menopause".
- Patients with acquired organic lesions or decreased ovarian function caused by ovarian surgery.
- Patients who have undergone artificial cycle therapy with Western medicine or other endocrine treatments within the past three months.
- Patients with severe primary diseases and mental disorders such as crdiovascular, cerebrovascular, liver, kidney, and hematopoietic system.
- Patients during lactation or pregnancy.
- Patients who are allergic to the drugs used in this study or have a history of allergic reactions to traditional Chinese medicine.
- Those who meet any of the above 5 criteria for DOR and POI will be excluded and not included in this study. The exclusion criteria for healthy subjects are as (1), (3), (4), and (5).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Dongzhimen Hospital, Beijing University of Chinese Medicine
Beijing
Xueting Han, +861084012709, dzmyyec@126.com
Yun Shi, phD
About this study
Official title: Study on the Correlation Between Ovarian Function and Serum Biomarkers
The goal of this observational study is to find differences in serum biomarkers between ovarian function and normal individuals.
Read the detailed description
Collect the serum of the observation group and control group volunteers, and measure the levels of copper ions, iron ions, ceruloplasmin (CP), CuZn SOD, malondialdehyde (MDA), etc. in the serum.
- Conditions
- Premature Ovarian Insufficiency, Diminished Ovarian Reserve, Biomarker, Copper, Ceruloplasmin, Aging
- Being tested
- blood test
- 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.
blood testDiagnostic test
Detection of serum levels of copper ions, iron ions, ceruloplasmin (CP), CuZn SOD, malondialdehyde (MDA), etc. Blood samples will be retained from the rest samples for sex hormones samples for testing sex hormones, which don't increase times of blood collection.
| Study group | Role | What they receive |
|---|---|---|
| Diminished Ovarian Reserve Group | women with DOR Receives: Diagnostic Test: blood test | |
| Premature Ovarian Insufficiency Group (POI) | women with premature ovarian insufficiency Receives: Diagnostic Test: blood test | |
| Control Group | women with normal menstruation and levels of sex hormones Receives: Diagnostic Test: blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
copper
the level of copper in blood sample
Measured: On the 2~4th day of menstruation (amenorrhea patients on the enrolled week)
Iron ion
the level of Iron ion in blood sample
Measured: On the 2~4th day of menstruation (amenorrhea patients on the enrolled week)
ceruloplasmin, CP
the level of ceruloplasmin in blood sample
Measured: On the 2~4th day of menstruation (amenorrhea patientson the enrolled week)
CuZn-Superoxide Dismutase, CuZn-SOD/SOD1
the level of CuZn-SOD/SOD1 in blood sample
Measured: On the 2~4th day of menstruation (amenorrhea patients on the enrolled week)
Malondialdehyde，MDA
the level of MDA in blood sample
Measured: On the 2~4th day of menstruation (amenorrhea patients on the enrolled week)
Secondary outcomes (1)
other relative biomarkers about copper/iron metabolism and oxidative stress
depending on the results of the five biomarkers above
Measured: On the 2~4th day of menstruation (amenorrhea patients on the enrolled week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start25 Oct 2023
- Primary completion11 Nov 2025 (estimated)
- Study completion11 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature Ovarian InsufficiencyStudies of the same condition, open and under way.
- 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
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shi Yun
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shi Yun, Dongzhimen Hospital, Beijing
- Investigators
- Yun Shi, PhD, Study director, Dongzhimen Hospital of Beijing University of Chinese MedicineKe Xu, Master, Principal investigator, Dongzhimen Hospital of Beijing University of Chinese MedicineJing Y Shao, Master, Study chair, Dongzhimen Hospital of Beijing University of Chinese MedicineXuan kai Cai, Master, Study chair, Shenzhen Bao'an Authentic TCM Therapy HospitalQin Y Liu, Bachelor, Study chair, Dongzhimen Hospital of Beijing University of Chinese MedicineXi Y Li, Bachelor, Study chair, Dongzhimen Hospital of Beijing University of Chinese MedicineFei Yan, Master, Study chair, Dongzhimen Hospital of Beijing University of Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06096766
- Sponsor's protocol ID
- 2023DZMEC-489
- Status last verified
- Dec 2024
- First submitted
- 18 Oct 2023
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Correlation Between Ovarian Function and Serum Biomarkers
- ClinicalTrials.gov ID
- NCT06096766
- Acronym / sponsor ID
- 2023DZMEC-489
- Conditions
- Premature Ovarian Insufficiency, Diminished Ovarian Reserve, Biomarker, Copper, Ceruloplasmin, Aging
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Shi YunUniversity, hospital or other
- Study start
- 25 Oct 2023 (actual)
- Primary completion
- 11 Nov 2025 (estimated)
- Study completion
- 11 Nov 2025 (estimated)
- First posted
- 24 Oct 2023 (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.
The goal of this observational study is to find differences in serum biomarkers between ovarian function and normal individuals.
Detailed description
Collect the serum of the observation group and control group volunteers, and measure the levels of copper ions, iron ions, ceruloplasmin (CP), CuZn SOD, malondialdehyde (MDA), etc. in the serum.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Diminished Ovarian Reserve Group | – | Diagnostic Test: blood testwomen with DOR |
| Premature Ovarian Insufficiency Group (POI) | – | Diagnostic Test: blood testwomen with premature ovarian insufficiency |
| Control Group | – | Diagnostic Test: blood testwomen with normal menstruation and levels of sex hormones |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Visited the gynecology clinic of Dongzhimen Hospital from November 2023 to October 2024. Upon examination of sexual hormones or AMH, it was considered that patients with Diminished Ovarian Reserve (DOR), premature ovarian insufficiency (POI), and healthy individuals had decreased ovarian reserve function.
Key inclusion criteria (13 listed)
- The selection criteria for healthy individuals are follows.
- The selection criteria for DOR patients are follows.
- Selection criteria for POI patients are follows.
Key exclusion criteria (7 listed)
- Patients with congenital gonadal developmental abnormalities or a family history similar to "early menopause".
- Patients with acquired organic lesions or decreased ovarian function caused by ovarian surgery.
- Patients who have undergone artificial cycle therapy with Western medicine or other endocrine treatments within the past three months.
- Patients with severe primary diseases and mental disorders such as crdiovascular, cerebrovascular, liver, kidney, and hematopoietic system.
- Patients during lactation or pregnancy.
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 |
|---|---|---|
| blood testDetection of serum levels of copper ions, iron ions, ceruloplasmin (CP), CuZn SOD, malondialdehyde (MDA), etc. Blood samples will be retained from the rest samples for sex hormones samples for testing sex hormones, which don't increase times of blood collection. | Diagnostic test | Control Group, Diminished Ovarian Reserve Group, Premature Ovarian Insufficiency Group (POI) |
Primary outcome
copper
Time frame: On the 2~4th day of menstruation (amenorrhea patients on the enrolled week)
the level of copper in blood sample
Iron ion
Time frame: On the 2~4th day of menstruation (amenorrhea patients on the enrolled week)
the level of Iron ion in blood sample
ceruloplasmin, CP
Time frame: On the 2~4th day of menstruation (amenorrhea patientson the enrolled week)
the level of ceruloplasmin in blood sample
CuZn-Superoxide Dismutase, CuZn-SOD/SOD1
Time frame: On the 2~4th day of menstruation (amenorrhea patients on the enrolled week)
the level of CuZn-SOD/SOD1 in blood sample
Malondialdehyde，MDA
Time frame: On the 2~4th day of menstruation (amenorrhea patients on the enrolled week)
the level of MDA in blood sample
1 secondary outcome
other relative biomarkers about copper/iron metabolism and oxidative stress
Time frame: On the 2~4th day of menstruation (amenorrhea patients on the enrolled week)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Individual participant dataSharing planned: No
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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.
Yun Shi, PhD study director
Dongzhimen Hospital of Beijing University of Chinese Medicine
Ke Xu, Master principal investigator
Dongzhimen Hospital of Beijing University of Chinese Medicine
Jing Y Shao, Master study chair
Dongzhimen Hospital of Beijing University of Chinese Medicine
1 site 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 Shi Yun at 1 site 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 13 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yun Shi, PhD (13717926522, zysyun@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
copper (time frame: On the 2~4th day of menstruation (amenorrhea patients on the enrolled week)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Dec 2024.