Traditional Chinese Medicine: Dingkun Dan 7g, twice daily (bid) for 21 days per month, administered orally for 3 treatment cycles.
Photodynamic therapy (PDT): LLLT: 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: Placebo: Simulated Dingkun Dan preparation, 7g, twice daily (bid) for 21 days per month, administered orally for 3 treatment cycles.
Study 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.
Eligibility
Sex
FEMALE
Min age
25 Years
Max age
40 Years
Healthy volunteers
Accepted
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 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.
Primary outcome measure(s)
Change in serum anti-Müllerian hormone (AMH) concentration — At 3 months after treatment initiation. Change in serum anti-Müllerian hormone (AMH) concentration, measured as the difference from baseline.
Change in serum follicle-stimulating hormone (FSH) concentration — At 3 months after treatment initiation. Change in serum follicle-stimulating hormone (FSH) concentration, measured as the difference from baseline.
Change in antral follicle count (AFC) — At 3 months after treatment initiation. Change in antral follicle count (AFC), measured as the difference from baseline.
Trial sites (1)
Facility
City
Region
Status
Peking union medical college hospital
Beijing
Beijing Municipality
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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