An observational study in Premature Ovarian Insufficiency, Diminished Ovarian Reserve and Biomarker, sponsored by Shi Yun. Recruiting at 1 site in China. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-09.
Sponsored by Shi Yun · Observational
The goal of this observational study is to find differences in serum biomarkers between ovarian function and normal individuals.
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.
181 studies on the registry are indexed under Primary Ovarian Insufficiency; 48 are open to participants now.
This study's planned enrollment of 35 is below the median of 100 across 61 observational studies indexed under Primary Ovarian Insufficiency.
Browse Primary Ovarian Insufficiency studies →Shi Yun is the lead sponsor of 7 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
The selection criteria for DOR patients are follows.
women aged 18-45.
For two consecutive menstrual cycles, 25 ≥ basal FSH ≥ 10IU/L or AMH\<1.1ng/ml.
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.
Exclusion Criteria:
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).
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
women with DOR
Diagnostic Test: blood test
women with premature ovarian insufficiency
Diagnostic Test: blood test
women with normal menstruation and levels of sex hormones
Diagnostic Test: blood 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.
copper
the level of copper in blood sample
Time frame: On the 2~4th day of menstruation (amenorrhea patients on the enrolled week)
Iron ion
the level of Iron ion in blood sample
Time frame: On the 2~4th day of menstruation (amenorrhea patients on the enrolled week)
ceruloplasmin, CP
the level of ceruloplasmin in blood sample
Time frame: 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
Time frame: On the 2~4th day of menstruation (amenorrhea patients on the enrolled week)
Malondialdehyde，MDA
the level of MDA in blood sample
Time frame: On the 2~4th day of menstruation (amenorrhea patients on the enrolled week)
other relative biomarkers about copper/iron metabolism and oxidative stress
depending on the results of the five biomarkers above
Time frame: On the 2~4th day of menstruation (amenorrhea patients on the enrolled week)
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2023 (actual). Primary completion is estimated for Nov 2025, 24 months after the start.
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