NCT07376824

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: Female
• Age: 25 Years – 40 Years
• Healthy volunteers: Accepted

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.

Detailed description

Ovarian reserve can reflect a woman's fertility and the outcomes of assisted reproductive technology. If not treated promptly, it may progress to Premature Ovarian Failure (POF) within 1 to 6 years, severely affecting a woman's physical and mental health. Studies have found that the incidence of DOR in the female population is approximately 10%, while the prevalence of DOR among infertile women is about 24%, showing an increasing trend year by year and affecting younger age groups. Extensive studies have confirmed that traditional Chinese medicine, as well as integrated traditional Chinese and Western medicine treatments, have certain therapeutic effects on DOR in clinical practice. Early intervention for DOR can improve ovarian reserve function and increase the pregnancy rate. This study will be conducted as a prospective, randomized, controlled clinical trial. Eligible subjects will be randomly assigned to three groups: Combination Therapy Group, Photodynamic Therapy Group, Chinese Medicine Group. After three months of treatment, the study will conduct clinical and metabolomics-based research on DOR patients to: (1) Clarify the role and efficacy of acupoint photodynamic therapy, both alone and in combination with Chinese medicine, in improving or enhancing the effects of traditional Chinese medicine on ovarian reserve function. (2) Explore new metabolic biomarkers for the diagnosis and efficacy evaluation of ovarian reserve function. (3) Identify the distinct metabolic pathways through which acupoint photodynamic therapy and Chinese medicine improve ovarian reserve function. (4) Establish an integrated biomarker index system for the diagnosis and treatment evaluation of DOR using acupoint photodynamic therapy and traditional Chinese medicine, and elucidate the mechanisms of action and pharmacodynamic material basis for improving ovarian reserve function.

Conditions

• Diminished Ovarian Reserve (DOR)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-12-20
• Primary completion: 2026-12-01
• Completion: 2026-12-31
• First posted: 2026-01-29
• Last updated: 2026-01-29

Locations

1 site across 1 country: China