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

NCT07376824 | Recruiting Phase 3 DMC

• 1 other identifier: SF2024
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

diminished ovarian reserve; Integrated Traditional Chinese and Western Clinical Medicine; Randomized controlled trial; Photodynamic Therapy; metabolomics

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Change in serum concentrations of biochemical markers

  At 3 months after treatment initiation.

• Change in menstrual blood loss assessed by the Pictorial Blood Loss Assessment Chart (PBAC)

  At 3 months after treatment initiation.

• Change in traditional Chinese medicine (TCM) syndrome score for menstrual disorders

  At 3 months after treatment initiation.

• Change in health-related quality of life

  At 3 months after treatment initiation.

Study Arms (3)

Combination Therapy Group

EXPERIMENTAL

LLLT (acupoint photodynamic therapy) + Dingkun Dan Group

Drug: Traditional Chinese Medicine; Device: Photodynamic therapy (PDT)

Photodynamic Therapy Group

PLACEBO COMPARATOR

LLLT (acupoint photodynamic therapy) + placebo (Dingkun Dan Simulant)

Device: Photodynamic therapy (PDT); Drug: Placebo

Chinese Medicine Group

ACTIVE COMPARATOR

Dingkun Dan Monotherapy Group

Drug: Traditional Chinese Medicine

Interventions

Photodynamic therapy (PDT) DEVICE

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.

Combination Therapy Group; Photodynamic Therapy Group

Placebo DRUG

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

Photodynamic Therapy Group

Traditional Chinese Medicine DRUG

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

Chinese Medicine Group; Combination Therapy Group

Eligibility Criteria

• Age: 25 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking union medical college hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Interventions

Medicine, Chinese Traditional; Photochemotherapy

Intervention Hierarchy (Ancestors)

Medicine, East Asian Traditional; Medicine, Traditional; Complementary Therapies; Therapeutics; Combined Modality Therapy; Drug Therapy; Phototherapy

Central Study Contacts

Yingying Guo, Doctor

CONTACT

86+010-69158331; guoyy28@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: January 29, 2026
• Study Start: December 20, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 29, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)