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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Change in serum anti-Müllerian hormone (AMH) concentration [Срок оценки: At 3 months after treatment initiation.]
• Change in serum follicle-stimulating hormone (FSH) concentration [Срок оценки: At 3 months after treatment initiation.]
• Change in antral follicle count (AFC) [Срок оценки: At 3 months after treatment initiation.]

Вторичные конечные точки (4)

• Change in serum concentrations of biochemical markers [Срок оценки: At 3 months after treatment initiation.]
• Change in menstrual blood loss assessed by the Pictorial Blood Loss Assessment Chart (PBAC) [Срок оценки: At 3 months after treatment initiation.]
• Change in traditional Chinese medicine (TCM) syndrome score for menstrual disorders [Срок оценки: At 3 months after treatment initiation.]
• Change in health-related quality of life [Срок оценки: At 3 months after treatment initiation.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Peking union medical college hospital — Пекин

Идентификаторы

NCT: NCT07376824 · SF2024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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