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

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.

Study Overview

• Status: Recruiting
• Conditions: Diminished Ovarian Reserve (DOR)
• Intervention / Treatment: Drug: Traditional Chinese Medicine; Device: Photodynamic therapy (PDT); Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Yingying Guo, Doctor; Phone Number: 86+010-69158331; Email: guoyy28@gmail.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100730
      • Recruiting
      • Peking Union Medical College Hospital
      • Contact: Yingying Guo, Doctor; Phone Number: 86+010-69158331; Email: guoyy28@gmail.com
      • Principal Investigator: Aijun Sun, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Combination Therapy Group; LLLT (acupoint photodynamic therapy) + Dingkun Dan Group	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.
Placebo Comparator: Photodynamic Therapy Group; LLLT (acupoint photodynamic therapy) + placebo (Dingkun Dan Simulant)	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.
Active Comparator: Chinese Medicine Group; Dingkun Dan Monotherapy Group	Drug: Traditional Chinese Medicine; Dingkun Dan 7g, twice daily (bid) for 21 days per month, administered orally for 3 treatment cycles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in serum anti-Müllerian hormone (AMH) concentration	Change in serum anti-Müllerian hormone (AMH) concentration, measured as the difference from baseline.	At 3 months after treatment initiation.
Change in serum follicle-stimulating hormone (FSH) concentration	Change in serum follicle-stimulating hormone (FSH) concentration, measured as the difference from baseline.	At 3 months after treatment initiation.
Change in antral follicle count (AFC)	Change in antral follicle count (AFC), measured as the difference from baseline.	At 3 months after treatment initiation.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At 3 months after treatment initiation.
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.	At 3 months after treatment initiation.
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.	At 3 months after treatment initiation.
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.	At 3 months after treatment initiation.

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: December 2, 2025
• First Submitted That Met QC Criteria: January 21, 2026
• First Posted (Actual): January 29, 2026

Study Record Updates

• Last Update Posted (Actual): January 29, 2026
• Last Update Submitted That Met QC Criteria: January 21, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Randomized controlled trial; Photodynamic Therapy; metabolomics; diminished ovarian reserve; Integrated Traditional Chinese and Western Clinical Medicine
• Additional Relevant MeSH Terms: Therapeutics; Drug Therapy; Complementary Therapies; Combined Modality Therapy; Phototherapy; Medicine, East Asian Traditional; Medicine, Traditional; Photochemotherapy; Medicine, Chinese Traditional
• Other Study ID Numbers: SF2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No