Acupoint photodynamic therapy with or without Dingkun Dan to improve ovarian reserve
Clinical and Metabolomics Studies on the Improvement of Ovarian Reserve by Acupoint Photodynamic Therapy and Traditional Chinese Medicine Treatment
PHASE3 · Peking Union Medical College Hospital · NCT07376824
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 | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 25 Years to 40 Years |
| Sex | Female |
| Sponsor | Peking Union Medical College Hospital (other) |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT07376824 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Beijing, Beijing Municipality
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Diminished Ovarian Reserve, diminished ovarian reserve, Integrated Traditional Chinese and Western Clinical Medicine, Randomized controlled trial, Photodynamic Therapy, metabolomics