Acupoint photodynamic therapy with or without Dingkun Dan to improve ovarian reserve
Official title: Clinical and Metabolomics Studies on the Improvement of Ovarian Reserve by Acupoint Photodynamic Therapy and Traditional Chinese Medicine Treatment
Run by Peking Union Medical College Hospital · NCT07376824 · Data updated 2026-11-12
This study will test whether acupoint photodynamic therapy, alone or combined with the Chinese medicine Dingkun Dan, can improve ovarian reserve in women aged 25–40 with diminished ovarian reserve.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 25 Years to 40 Years |
| Sex | Women only |
| Enrollment | 90 (estimated) |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | December 20, 2024 |
| Main results expected | December 1, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | January 29, 2026 |
| Trial ID | NCT07376824 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 25–40 with diminished ovarian reserve (meeting at least two criteria such as basal FSH 10–25 IU/L, AMH <1.1 ng/mL, or AFC <7) who meet TCM kidney-deficiency criteria and agree to a 3-month in-person treatment protocol.
✕Probably not a fit
Patients with organic ovarian or endocrine disorders (for example ovarian tumors, PCOS, hyperprolactinemia, thyroid dysfunction), recent sex-hormone therapy, serious unstable systemic disease, or inability to attend the Beijing study center are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This single-center, prospective, randomized, parallel Phase 3 trial at Peking Union Medical College Hospital will randomize eligible women with diminished ovarian reserve to three 3-month arms: LLLT (acupoint photodynamic therapy) plus placebo, LLLT plus Dingkun Dan, or Dingkun Dan alone. Clinical ovarian reserve measures (basal FSH, AMH, AFC) and serum metabolomic profiles will be collected at baseline and after treatment to compare biochemical and metabolic changes between groups. The design tests whether photodynamic stimulation adds to or enhances the effects of traditional Chinese medicine on ovarian function. Secondary aims include identifying metabolomic biomarkers for diagnosis and treatment response.
Why it matters
Potential benefit: If successful, the interventions could improve ovarian reserve markers, help delay progression to premature ovarian failure, and potentially increase pregnancy chances.
How similar studies have gone: Some clinical studies report benefits of traditional Chinese medicine for DOR, but acupoint photodynamic therapy is a novel approach with limited high-quality randomized evidence so far.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Peking union medical college hospital
Beijing, Beijing Municipality, China Recruiting
Study contacts
- Study coordinator: Yingying Guo, Doctor
- Email: guoyy28@gmail.com
- Phone: 86+010-69158331
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.