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.
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.
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 physical diseases, including liver, kidney, gastrointestinal, cardiovascular, respiratory, endocrine, neurological, immune or hematological, neurological and psychiatric systems,
History of substance (alcohol or drug) abuse or dependence within the past 3 months; heavy smokers (defined as those who smoke 20 or more cigarettes per day)
Previous allergy to the investigational drug or photosensitivity, or individuals with contraindications to Dingkun Dan ⑥ Have participated in another clinical trial of a investigational drug within the month prior to inclusion in this study (first interview) ⑦ Other conditions that, in the judgment of the investigator, may reduce the likelihood of enrollment or complicate the enrollment process, such as frequent job changes or other circumstances prone to loss to follow-up.
Parallel
Traditional Chinese Medicine
DrugDingkun Dan 7g, twice daily (bid) for 21 days per month, administered orally for 3 treatment cycles.
Photodynamic therapy (PDT)
DeviceLLLT: The acupoint phototherapy device, with a peak wavelength of 630nm ± 20nm and an output optical power of 1-2.5mW, was used. Treatment commenced after the end of the menstrual period, once daily for 20 minutes per session, for 5 days (constituting one treatment cycle). After a 2-day interval, the next treatment cycle began, continuing until the onset of the next menstruation.
Placebo
DrugPlacebo: Simulated Dingkun Dan preparation, 7g, twice daily (bid) for 21 days per month, administered orally for 3 treatment cycles.
Change in serum anti-Müllerian hormone (AMH) concentration
Change in serum anti-Müllerian hormone (AMH) concentration, measured as the difference from baseline.
Change in serum follicle-stimulating hormone (FSH) concentration
Change in serum follicle-stimulating hormone (FSH) concentration, measured as the difference from baseline.
Change in antral follicle count (AFC)
Change in antral follicle count (AFC), measured as the difference from baseline.
Change in serum concentrations of biochemical markers
Changes in serum concentrations of prostaglandin E2 (PGE2), prostaglandin F2α (PGF2α), endothelin (ET), nitric oxide (NO), β-endorphin, and oxytocin (OT), measured as the change from baseline.
Change in menstrual blood loss assessed by the Pictorial Blood Loss Assessment Chart (PBAC)
Change in menstrual blood loss assessed using the Pictorial Blood Loss Assessment Chart (PBAC), a validated semi-quantitative scale ranging from 0 to \>500, with higher scores indicating greater menstrual blood loss, measured as the change from baseline.
Change in traditional Chinese medicine (TCM) syndrome score for menstrual disorders
Change in traditional Chinese medicine (TCM) syndrome score for menstrual disorders assessed using a quantitative TCM syndrome differentiation scale for menstrual disorders, consisting of major and minor symptom items. The total score ranges from 0 to 42, with higher scores indicating greater symptom severity, measured as the change from baseline.
Change in health-related quality of life
Change in health-related quality of life assessed using the 36-Item Short Form Health Survey (SF-36), a validated questionnaire with domain scores ranging from 0 to 100, where higher scores indicate better health-related quality of life, measured as the change from baseline.
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