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RECRUITING
NCT07376824
PHASE3

Clinical and Metabolomics Studies on the Improvement of Ovarian Reserve by Acupoint Photodynamic Therapy and Traditional Chinese Medicine Treatment

Sponsor: Peking Union Medical College Hospital

View on ClinicalTrials.gov

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.

Key Details

Gender

FEMALE

Age Range

25 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2024-12-20

Completion Date

2026-12-31

Last Updated

2026-01-29

Healthy Volunteers

Yes

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

Placebo: Simulated Dingkun Dan preparation, 7g, twice daily (bid) for 21 days per month, administered orally for 3 treatment cycles.

Locations (1)

Peking union medical college hospital

Beijing, Beijing Municipality, China