A Phase 3 Trial of Yulinzhu Herbal Treatment for Women Aged 18 to 40 With Diminished Ovarian Reserve to Improve Fertility

What This Trial Is About

This trial investigates the use of traditional Chinese medicine TCM for women with diminished ovarian reserve DOR, a condition affecting fertility. The study aims to evaluate whether a 12-week course of TCM herbal therapy, taken five days per week, can improve ovarian function indicators such as serum anti-Mullerian hormone AMH, follicle stimulating hormone FSH, bilateral antral follicle count AFC, and Traditional Chinese Medicine Symptom Score TCMSS. The study is a randomized, waiting-list controlled crossover trial designed to compare the effects of TCM treatment with a waiting period without treatment. Participants are divided into two groups. One group receives TCM herbal treatment for 12 weeks, with TCMSS assessments every two weeks, followed by a 12-week waiting period and then in vitro fertilization IVF treatment. The other group starts with a 12-week waiting period, followed by the same 12-week TCM treatment with regular symptom score assessments, and then IVF treatment. The TCM treatment uses Yulinzhu, a Chinese medicinal formula with specific herbal components, with possible prescription variations based on practitioner consultation. During the study, participants undergo ovarian function tests including AMH and FSH measurements, pelvic ultrasounds to assess AFC, and repeated TCM symptom scoring up to 18 months. These tests occur before treatment, at 12 weeks, and at 24 weeks. The study monitors changes in these measures to assess the effects of the treatment. Participants receive evaluations before and after each treatment phase, and the overall study duration includes treatment and waiting periods before IVF treatment.

Yulinzhu for Women With Diminished Ovarian Reserve