Yulinzhu for Women With Diminished Ovarian Reserve
ConditionDiminished Ovarian Reserve (DOR)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorThe University of Hong Kong
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.) ;
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;
Disqualifiers
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.
Trial design
Design model
Crossover
Treatments tested in this trial
Yulinzhu (a Chinese Medicinal Formulae)
DrugYulinzhu (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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Chinese Medicine herbal treatment groupExperimental treatment 1 intervention
Group B: waiting-list control groupOther 1 intervention
Trial outcomes
Primary outcomes
1
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.Secondary outcomes
1
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 24.2
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 24.3
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 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
The University of Hong Kong
Lead sponsor
Queen Mary Hospital, Hong Kong
Collaborator
Kwong Wah Hospital
Collaborator
Source ClinicalTrials.gov