Yulinzhu for Women With Diminished Ovarian Reserve: a Randomized, Waiting-list Controlled, Crossover Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- serum anti-Mullerian hormone (AMH)
研究概览
简要总结
This is a randomized waiting-list controlled crossover trial carried out to investigate the efficacy of traditional Chinese medicine (TCM) for DOR and its potential beneficial effects on fertility. Subjects' (1) Ovarian function (AMH, FSH), (2) Bilateral AFC as shown in pelvic ultrasound, and (3) Traditional Chinese Medicine Symptom Score (TCMSS) will be recorded. It is hypothesized that a 12-week course (5 days medication per week) of TCM herbal therapy for DOR patients will improve one or more of the above aspects when compared to the waiting-list control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None (Participant)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 18-40, with regular menstruation (cycle from 21 to 35 days) and reduced fertility (infertility, early miscarriage, recurrent pregnancy loss, recurrent implantation failure, etc.) ;
- •Tests of ovarian reserve within 6 months:
- •AMH < 1.1 ng/ml or (any day in cycle, refer to laboratory standards);
- •AFC < 7 follicles or (any day in cycle);
- •Received <3 cycles of IVF in public sector;
- •Subject has no history of allergy to TCM;
- •Subjects agree to receive IVF treatment upon the completion of this research within 12 weeks if they are not pregnant spontaneously; and
- •As diagnosed by Chinese Medicine practitioner through four diagnostic methods, suitable to receive Yulinzhu.
排除标准
- •Previous history of a unilateral or bilateral oophorectomy;
- •Recent administration of TCM for DOR within 3 months;
- •Diagnosis of pregnancy, premature ovarian failure, residual follicles, cysts or space-occupying lesions in the ovary, pelvic inflammatory disease or polycystic ovary syndrome; and
- •Cancer, untreated thyroid dysfunction, severe cardiovascular/cerebrovascular diseases, severe liver/kidney diseases or hematopoietic system diseases.
- •Subjects are allowed to withdraw from the trial for one of the following reasons:
- •(1) The patient fails to complete treatment due to safety or medical reasons; (2) The patient fails to follow treatment guidelines; (3) The patient is unwilling to continue treatment for any reason.
研究组 & 干预措施
Chinese Medicine herbal treatment group
After completing the screening process, Chinese Medicine herbal treatment group will start to receive the Chinese medicine treatment for 12 weeks, during which the TCMSS will be repeated once for every 2 weeks of oral Chinese medicine treatment, for a total of 5 times. At the end of the treatment period, subjects will repeat the same examinations they received before enrollment and enter a waiting list control period for 12 weeks. At the end of the waiting list control period, subjects will repeat the above tests again and undergo IVF treatment after 12 weeks.
干预措施: Yulinzhu (a Chinese Medicinal Formulae) (Drug)
waiting-list control group
After completing the screening process, waiting-list control group will enter a 12-week waiting list control period. At the end of the waiting list control period, the subjects will repeat the screening procedures they have undergone before enrollment. Upon completion of the screening process, the subject will start to receive Chinese medicine treatment for a period of 12 weeks, during which the TCMSS will be repeated once for every 2 sessions of oral Chinese medicine treatment, making a total of 5 sessions. At the end of the treatment, subjects in Group B will repeat the above tests and receive IVF treatment. The effect of the intervention will be evaluated by comparing the test data between groups and within groups.
干预措施: Yulinzhu (a Chinese Medicinal Formulae) (Drug)
结局指标
主要结局
serum anti-Mullerian hormone (AMH)
时间窗: will be performed on the first menstrual cycle before treatment, and then at week 12 and 24.
For all subjects, on the 2nd to 5th days of the menstrual cycle, 3-5 mL of blood will be collected from the arm-cubital vein once. ELISA (enzyme-linked immunosorbent assay) will be adopted to evaluate the level of AMH.
次要结局
- Follicle stimulating hormone (FSH)(will be performed on the first menstrual cycle before treatment, and then at week 12 and 24.)
- Pelvic ultrasound(This assessment will be carried out at baseline, week 12 and week 24.)
- Traditional Chinese Medicine Symptom Score (TCMSS)(Up to 18 months)
研究者
Dr. Lo Kwai Ching
Principal Investigator
The University of Hong Kong