Actively Recruiting
Bushen Yiqi Formula Combined With Dehydroepiandrosterone in Women With Diminished Ovarian Reserve
Led by Jiangxi University of Traditional Chinese Medicine · Updated on 2026-04-17
74
Participants Needed
1
Research Sites
117 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this clinical trial is to evaluate the efficacy and safety of Bushen Yiqi formula combined with dehydroepiandrosterone (DHEA) in the treatment of women with diminished ovarian reserve (DOR). The study also aims to assess the safety profile of this combined therapy. The main questions this study aims to answer include: 1. Can the Bushen Yiqi formula combined with DHEA improve ovarian reserve in women with DOR? 2. Does the combined treatment improve hormone levels, ovarian follicle parameters, and clinical symptoms? 3. What safety issues may occur during treatment with the Bushen Yiqi formula combined with DHEA? Researchers will compare the Bushen Yiqi formula combined with DHEA to DHEA plus placebo to determine whether the combined therapy is more effective in treating diminished ovarian reserve. Participants will: 1. Be randomly assigned to either the treatment group or the control group 2. Receive DHEA combined with the Bushen Yiqi formula or DHEA combined with placebo for 12 weeks 3. Undergo regular clinical assessments during the study period 4. Have ovarian reserve markers (including AMH and antral follicle count), sex hormone levels (FSH, LH, E2, and testosterone), traditional Chinese medicine symptom scores, Kupperman menopausal index scores, inflammatory markers (CRP and IL-6), and safety indicators evaluated before and after treatment
CONDITIONS
Official Title
Bushen Yiqi Formula Combined With Dehydroepiandrosterone in Women With Diminished Ovarian Reserve
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 20 to 40 years inclusive
- Diagnosis of diminished ovarian reserve (DOR) meeting both Western medical and traditional Chinese medicine criteria
- No use of estrogen or progestin medications in the past three months
- Voluntary participation with signed informed consent
You will not qualify if you...
- Presence of reproductive endocrine, metabolic, or immune disorders such as polycystic ovary syndrome, hyperprolactinemia, poorly controlled thyroid disease, Addison's disease, lupus, Crohn's disease, or poorly controlled diabetes
- DOR caused by tumor treatments, surgery, radiotherapy/chemotherapy, or ovarian hyperstimulation from prior IVF cycles
- Untreated or severe gynecological conditions including unexplained irregular vaginal bleeding, adnexal masses ≥4 cm, stage III-IV endometriosis or bilateral ovarian endometriomas, uterine fibroids ≥4 cm, endometrial polyps >1.5 cm, or planned pelvic surgery during the trial
- Reduced menstrual flow due to congenital uterine malformations, uterine hypoplasia, organic reproductive organ pathologies, or prior intrauterine procedures
- Severe diseases affecting cardiovascular, cerebrovascular, liver, kidney, hematopoietic systems, psychiatric disorders, or intellectual disabilities
- Pregnancy or breastfeeding
- Known allergy or hypersensitivity to study drug components
- Participation in another clinical trial within 3 months before randomization
- Unwillingness to sign informed consent form
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The Second Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine
Nanchang, Jiangxi, China
Actively Recruiting
Research Team
R
Ruining Liang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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