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| Name | Class |
|---|---|
| Queen Mary Hospital, Hong Kong | OTHER |
| Kwong Wah Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chinese Medicine herbal treatment group | Experimental | 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. |
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| waiting-list control group | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yulinzhu (a Chinese Medicinal Formulae) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | will be performed on the first menstrual cycle before treatment, and then at week 12 and 24. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | will be performed on the first menstrual cycle before treatment, and then at week 12 and 24. |
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Inclusion Criteria:
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:
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.
Exclusion Criteria:
(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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kwai Ching Lo, Dr | Contact | 852-3917 6462 | angelos@hku.hk |
| Name | Affiliation | Role |
|---|---|---|
| Kwai Ching Lo, Dr | The Univerisity of Hong Kong | Principal Investigator |
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| 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). |
| 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. | Up to 18 months |