Diminished Ovarian Reserve Clinical Trial
Official title:
The Efficacy and Safety of Chinese Herbal Compound TJAOA101 in Treatment of Diminished Ovarian Reserve: a Prospective, Multi-center and Before-after Study.
Currently, no drugs have been developed for DOR. We developed the Chinese herbal compound TJAOA101 and has validated its effects in animals. Here, we will perform a population-based, multicenter study to confirm the safety and efficacy of TJAOA101 in therapy of DOR. We aim to provide a solid evidence for TCM in therapy of DOR.
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | November 1, 2023 |
Est. primary completion date | November 1, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility | Inclusion Criteria: 1. The age range of patient is 18-40 years old. 2. Women with DOR, and wish to improve ovarian function or menopausal syndrome. The diagnostic criteria for DOR is as follows: If two of the following three tests of ovarian reserve function are met, DOR can be diagnosed: bilateral AFC<6; AMH < 1.1 ng/ml; 10 mIU/ml <bFSH<25 mIU/ml. 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. |
Country | Name | City | State |
---|---|---|---|
China | Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan |
Lead Sponsor | Collaborator |
---|---|
Tongji Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | recovery rate of ovarian function | As the definition of DOR is based on AMH or bFSH or AFC, the recovery of ovarian function is also based on the recovery of these indicators. In this study, the recovery of ovarian function is defined as serum AMH increased more than 50%, or serum bFSH decreased more than 50%, or antral follicle count(AFC) increased more than 50% compared with that before treatment,or recover to normal level. | 6 months | |
Secondary | recovery rate of menstruation | two consecutive periods return to normal. | 6 months |
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