Yulinzhu for Women With Diminished Ovarian Reserve
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Yulinzhu (a Chinese Medicinal Formulae).
- Who it may be relevant to
- Registry conditions: Diminished Ovarian Reserve (DOR). Basic parameters: 18 years — 40 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hong Kong
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Yulinzhu for Women With Diminished Ovarian Reserve: a Randomized, Waiting-list Controlled, Crossover Trial
Overview
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
- Drug Yulinzhu (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 tre
Primary outcome measures
- serum anti-Mullerian hormone (AMH) [Time frame: will be performed on the first menstrual cycle before treatment, and then at week 12 and 24.]
Secondary outcome measures (3)
- Follicle stimulating hormone (FSH) [Time frame: will be performed on the first menstrual cycle before treatment, and then at week 12 and 24.]
- Pelvic ultrasound [Time frame: This assessment will be carried out at baseline, week 12 and week 24.]
- Traditional Chinese Medicine Symptom Score (TCMSS) [Time frame: Up to 18 months]
Eligibility criteria
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:
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Hong Kong · 2 centers
- Kwung Wah Hospital — Hong Kong
- Queen Marry Hosipital — Hong Kong
Identifiers
NCT: NCT07550998 · DOR20241209