Diminished Ovarian Reserve (DOR)
Conditions
Keywords
Chinese Medicine, diminished ovarian reserve, Yulinzhu
Brief summary
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.
Interventions
DRUGYulinzhu (a Chinese Medicinal Formulae)
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.
Sponsors
The University of Hong Kong
Queen Mary Hospital, Hong Kong
Kwong Wah Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
1. 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.) ; 2. Tests of ovarian reserve within 6 months: 1. AMH \< 1.1 ng/ml or (any day in cycle, refer to laboratory standards); 2. AFC \< 7 follicles or (any day in cycle); 3. Received \<3 cycles of IVF in public sector; 3. Subject has no history of allergy to TCM; 4. Subjects agree to receive IVF treatment upon the completion of this research within 12 weeks if they are not pregnant spontaneously; and 5. As diagnosed by Chinese Medicine practitioner through four diagnostic methods, suitable to receive Yulinzhu.
Exclusion criteria
1. Previous history of a unilateral or bilateral oophorectomy; 2. Recent administration of TCM for DOR within 3 months; 3. Diagnosis of pregnancy, premature ovarian failure, residual follicles, cysts or space-occupying lesions in the ovary, pelvic inflammatory disease or polycystic ovary syndrome; and 4. Cancer, untreated thyroid dysfunction, severe cardiovascular/cerebrovascular diseases, severe liver/kidney diseases or hematopoietic system diseases. 5. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| serum anti-Mullerian hormone (AMH) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Follicle stimulating hormone (FSH) | 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. Electrochemiluminescence will be used to detect the level of serum FSH. |
| Pelvic ultrasound | This assessment will be carried out at baseline, week 12 and week 24. | 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). |
| Traditional Chinese Medicine Symptom Score (TCMSS) | Up to 18 months | 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. |
Countries
Hong Kong
Contacts
CONTACTKwai Ching Lecturer, PHD
PRINCIPAL_INVESTIGATORKwai Ching Lo, Dr
The Univerisity of Hong Kong
Outcome results
None listed