Yulinzhu for Women With Diminished Ovarian Reserve
ConditionDiminished Ovarian Reserve (DOR)
Trial statusNot yet recruiting
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
Qualifiers
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
Treatments tested in this trial
- Yulinzhu (a Chinese Medicinal Formulae)
Treatment groups
60 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
The University of Hong Kong
Lead sponsor
Queen Mary Hospital, Hong Kong
Collaborator
Kwong Wah Hospital
Collaborator
Source ClinicalTrials.gov