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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
Yulinzhu (毓麟珠) originally published in The Complete Compendium of \[Zhang\] Jingyue (景岳全書), the mechanisms of action are nourishing kidney essence, qi and blood . The Composition includes: Ginseng Radix et Rhizoma, Atractylodis Macrocephalae Rhizoma, Poria, Paeoniae Radix Alba, Chuanxiong Rhizoma, Glycyrrhizae Radix et Rhizoma, Angelicae Sinensis Radix, Rehmanniae Radix, Cuscutae Semen, Eucommiae Cortex, CervusnipponTemminck, Zanthoxyli Pericarpium. Both groups will receive Chinese Medicine treatment in form of ready-to-drink packaged Chinese medicine decoction during their treatment period. Subjects will receive Yulinzhu (毓麟珠) with variations allowed. Eight variations can be chosen. The prescription can be edited by applying 2 variations at most every two weeks after TCM consultation.
serum anti-Mullerian hormone (AMH)
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.
Time frame: will be performed on the first menstrual cycle before treatment, and then at week 12 and 24.
Follicle stimulating hormone (FSH)
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. Electrochemiluminescence will be used to detect the level of serum FSH.
Time frame: will be performed on the first menstrual cycle before treatment, and then at week 12 and 24.
Pelvic ultrasound
For all subjects, pelvic ultrasound will be performed on the 2nd to 5th days of the menstrual cycle (on the same day with blood taking) for bilateral ovarian antral follicle count (AFC).
Time frame: This assessment will be carried out at baseline, week 12 and week 24.
Traditional Chinese Medicine Symptom Score (TCMSS)
The revised Blatt-Kupperman Menopausal Index will be adopted: (i) Weighting factor: sweating/hot flushes (4 points); paresthesia, sleeplessness, melancholia (categorized as psychological symptoms), dyspareunia, nervousness, urinary tract symptoms (2 points); vertigo, arthralgia/myalgia (categorized as somatic symptoms), fatigue, palpitations, headache, dysesthesia (1 point). (ii) Severity score: asymptomatic (0 point); occasional symptoms (1 point); frequent symptoms (2 points); often and severe symptoms (3 points). (iii) Symptom score = weighting factor × severity score, and the total score is the sum of all symptom scores. (iv)Degree of menopause: mild = 7-15 points; moderate = 16-30 points; severe ≥ 30 points.
Time frame: Up to 18 months
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