Clinical and Metabolomics Studies on the Improvement of Ovarian Reserve by Acupoint Photodynamic Therapy and Traditional Chinese Medicine Treatment
Recruiting now · Phase 3 · Has a placebo group
Conditions studied: Diminished Ovarian Reserve (DOR)
In brief
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.
Key facts
- Study ID
- NCT07376824
- Run by
- Peking Union Medical College Hospital
- People needed
- 90
- Starts
- 2024-12-20
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2026-01-29
Who can join
Age: 25 and older, up to 40. Sex: female. Healthy volunteers: accepted.
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)
- 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 is running
- Peking union medical college hospital — Beijing, Beijing Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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