Clinical and Metabolomics Studies on the Improvement of Ovarian Reserve by Acupoint Photodynamic Therapy and Traditional Chinese Medicine Treatment
NCT07376824 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 90
Last updated 2026-01-29
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.
Conditions
- Diminished Ovarian Reserve (DOR)
Interventions
- DRUG
-
Traditional Chinese Medicine
Dingkun Dan 7g, twice daily (bid) for 21 days per month, administered orally for 3 treatment cycles.
- DEVICE
-
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.
- DRUG
-
Placebo: Simulated Dingkun Dan preparation, 7g, twice daily (bid) for 21 days per month, administered orally for 3 treatment cycles.
Sponsors & Collaborators
-
Peking Union Medical College Hospital
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 25 Years
- Max Age
- 40 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-12-20
- Primary Completion
- 2026-12-01
- Completion
- 2026-12-31
Countries
- China
Study Locations
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