Overview

A Clinical Study of Chinese Herbal Compound TJAOA101 in Therapy of Diminished Ovarian Reserve

Status:
Not yet recruiting
Trial end date:
2023-08-01
Target enrollment:
0
Participant gender:
Female
Summary
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.
Phase:
Early Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Tongji Hospital
Criteria
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
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.