Yulinzhu for Women With Diminished Ovarian Reserve (NCT07550998) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Yulinzhu for Women With Diminished Ovarian Reserve
60 participantsStarted 2026-04-24
Plain-language 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.
Who can participate
Age range18 Years – 40 Years
SexFEMALE
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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:
✓. 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.
What they're measuring
1
serum anti-Mullerian hormone (AMH)
Timeframe: will be performed on the first menstrual cycle before treatment, and then at week 12 and 24.