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:
2025-12-25 @ 2:33 AM
Ignite Modification Date:
2025-12-25 @ 2:33 AM
NCT ID:
NCT05522634
Eligibility Criteria:
Inclusion Criteria:
1. The age range of patient is 18-40 years old.
2. The diagnostic criteria for POI is as follows: Age \<40; and menopause or sporadic menstruation for more than 4 months; and bFSH\>25 mIU/ml (the interval between two reexaminations should be more than one month, both reached this level)
3. Sign the informed consent form.
Exclusion Criteria:
1. Patient is known to be allergic or unsuitable for the Chinese herbal compound.
2. Women who are pregnant and lactating.
3. Patients had been menopause for more than 1 year.
4. Abnormal uterine bleeding, except ovulation disorders.
5. Women is taking hormone drugs and has stopped taking them within 3 months;
6. Women with endometriosis, myadenosis, submucosal fibroids or the size of non- submucosal fibroids is more than 4 cm.
7. The nature of pelvic mass is unknown.
8. Women with polycystic ovary syndrome, hyperprolactinemia, hyperandrogenemia, diabetes, thyroid and adrenal dysfunction and other endocrine diseases affecting ovulation.
9. Patients with serious primary diseases such as cardiovascular, liver, kidney, lung, biliary, hematopoietic system (Hb\<90g/L) and malignant tumor, and psychiatric patients.
10. Patients are participating in other clinical trials or have participated in other clinical trials within the last month.
11. Unsuitable for the study evaluated by the investigator.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT05522634
Study Brief:
Protocol Section:
NCT05522634