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 @ 2:08 AM
Ignite Modification Date:
2025-12-25 @ 2:08 AM
NCT ID:
NCT07124260
Eligibility Criteria:
Inclusion Criteria Developed in accordance with:
The 13th Five-Year Plan textbook Obstetrics and Gynecology (9th Edition) by China National Health Commission The 14th Five-Year Plan National Key Publication Reproductive Endocrinology (2nd Edition) Expert Consensus on Clinical Diagnosis and Treatment of Diminished Ovarian Reserve (2022)
Inclusion Criteria:
* Female patients aged \>20 years.
* Diagnosis required meeting the essential criterion of AMH \<1.1 ng/mL plus at least one supportive criterion: FSH \>10 IU/L, FSH/LH ratio \>3.0, or AFC \<5-7 follicles (measured on menstrual days 2-3).
* Conscious with intact cognitive/linguistic functions to comply with study protocols.
* Approved by Ethics Committee of Hangzhou TCM Hospital Affiliated to Zhejiang Chinese Medical University, with written informed consent obtained.
Exclusion Criteria:
* Female participants aged \<20 years.
* Women in menopause, pregnancy, or lactation period.
* Participants with comorbidities that may interfere with drug efficacy (e.g., severe chronic diseases).
* Severe primary disorders involving cardiovascular, hepatic, renal, hematopoietic systems, or psychiatric illnesses.
* Non-compliance with medication protocols during the study, or cases with undeterminable efficacy outcomes/incomplete data.
* Use of sex hormone therapy within the past 3 months.
* Diagnosis of reproductive system malignancies.
* Gastrointestinal disorders or abnormal liver function.
* Poor adherence to study protocols or lost to follow-up.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
20 Years
Study:
NCT07124260
Study Brief:
Protocol Section:
NCT07124260