Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2025-12-24 @ 4:16 PM
NCT ID:
NCT06096766
Eligibility Criteria:
Inclusion Criteria:
1. 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.
2. 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.
* Agree and sign an informed consent form.
3. 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.
Exclusion Criteria:
1. Patients with congenital gonadal developmental abnormalities or a family history similar to "early menopause".
2. Patients with acquired organic lesions or decreased ovarian function caused by ovarian surgery.
3. Patients who have undergone artificial cycle therapy with Western medicine or other endocrine treatments within the past three months.
4. Patients with severe primary diseases and mental disorders such as crdiovascular, cerebrovascular, liver, kidney, and hematopoietic system.
5. Patients during lactation or pregnancy.
6. 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).
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT06096766
Study Brief:
Protocol Section:
NCT06096766