Clinical and Metabolomics Studies on the Improvement of Ovarian Reserve by Acupoint Photod
Diminished Ovarian Reserve (DOR) refers to a reduction in the number of recruitable follicles in the ovaries and/or a decline in oocyte quality. Current research on its etiology and treatment remains unsatisfactory. This study will be conducted as a single-center, prospective, parallel, randomized, controlled clinical
| Condition(s) | Diminished Ovarian Reserve (DOR) |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Summary | Diminished Ovarian Reserve (DOR) refers to a reduction in the number of recruitable follicles in the ovaries and/or a decline in oocyte quality. Current research on its etiology and treatment remains unsatisfactory. This study will be conducted as a single-center, prospective, parallel, randomized, controlled clinical trial in DOR patients. Eligible subjects will be randomly assigned to three groups: LLLT (acupoint photodynamic therapy) + placebo (Dingkun Dan Simulant), LLLT (acupoint photodynamic therapy) + Chinese medicine (Dingkun Dan), and Chinese medicine (Dingkun Dan) alone. Clinical data and serum metabolomics will be assessed at baseline and after the 3-month treatment. |
| Who can participate | Inclusion Criteria: * Female patients aged 25 to 40 years * Meet the diagnostic criteria for diminished ovarian reserve (requiring at least two of the following: Basal FSH 10-25 IU/L; AMH \< 1.1 ng/mL; AFC \< 7) ③ Meet the diagnostic criteria for kidney deficiency syndrome in traditional Chinese medicine ④ Voluntarily participate in this study and provide written informed consent. Exclusion Criteria: * Organic lesions such as ovarian tumors, pituitary adenomas, endometrial tuberculosis, intrauterine adhesions or endometrial damage after abortion, as well as polycystic ovary syndrome, hyperprolactinemia, congenital adrenal hyperplasia, Cushing's syndrome, and thyroid dysfunction * Female infertility patients who have been treated with sex hormones in the past 3 months ③ Serious or unstable |
| Ages | 25 Years to 40 Years |
| Sex | Female |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Peking Union Medical College Hospital |
| Locations | Beijing, Beijing Municipality, China |
| Start date | 2024-12-20 |
| NCT ID | NCT07376824 |
| Official listing | https://clinicaltrials.gov/study/NCT07376824 |