Bushen Yiqi herbal formula plus DHEA for women with diminished ovarian reserve

A Randomized, Double-Blind, Placebo-Controlled Trial of Bushen Yiqi Formula Versus Chinese Herbal Placebo Combined With Dehydroepiandrosterone for the Treatment of Diminished Ovarian Reserve

This trial will test whether adding the Bushen Yiqi herbal formula to DHEA helps women aged 20–40 with diminished ovarian reserve improve ovarian function and symptoms.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 74 (estimated)
• Ages: 20 Years to 40 Years
• Sex: Female
• Sponsor: Jiangxi University of Traditional Chinese Medicine (Academic / other)
• Drugs / interventions: Chemotherapy
• Locations: 1 site (Nanchang, Jiangxi)
• Trial ID: NCT07535983 on ClinicalTrials.gov

What this trial studies

This Phase 1–2, randomized, placebo-controlled trial will compare DHEA combined with the Bushen Yiqi formula versus DHEA plus placebo in women diagnosed with diminished ovarian reserve. Eligible participants are 20–40 years old and must meet both Western medical and Traditional Chinese Medicine diagnostic criteria for DOR. Participants will be randomly assigned to the treatment or control group and followed for changes in ovarian reserve markers, hormone levels, follicle parameters, clinical symptoms, and adverse events. The study is conducted at the Second Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine in Nanchang, Jiangxi.

Who should consider this trial

Good fit: Women aged 20–40 with diminished ovarian reserve who meet both Western and TCM diagnostic criteria and who have not used estrogen or progestin in the prior three months are the intended participants.

Not a fit: Patients whose DOR is due to iatrogenic causes (such as prior surgery or chemotherapy) or who have uncontrolled endocrine, metabolic, or autoimmune disorders (for example PCOS, uncontrolled thyroid disease, or active SLE) are excluded and are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the combined therapy could improve ovarian reserve markers, hormone balance, and related symptoms for women with diminished ovarian reserve.

How similar studies have performed: Previous trials of DHEA for diminished ovarian reserve have shown mixed, modest results, while combining DHEA with TCM herbal formulas is relatively novel and has limited high-quality evidence.

Eligibility criteria

Inclusion Criteria:

1. Patients who meet both the Western medical diagnostic criteria for DOR and the Traditional Chinese Medicine (TCM) diagnostic criteria.
2. Female patients aged 20-40 years (inclusive).
3. No use of estrogen or progestin medications within the past three months.
4. Voluntary participation in this study, with informed consent provided and a written informed consent form signed.

Exclusion Criteria:

1. Concurrent reproductive endocrine, metabolic, or immune system disorders that could affect ovarian reserve or confound the evaluation of treatment efficacy, including:Polycystic ovary syndrome(PCOS),Hyperprolactinemia (a single elevated prolactin level \> 3 times the upper limit of normal),Poorly controlled thyroid disease (thyroid-stimulating hormone \[TSH\] outside the normal reference range),Addison's disease,Systemic lupus erythematosus (SLE),Crohn's disease,Poorly controlled diabetes mellitus, etc.
2. Diminished ovarian reserve (DOR) attributable to iatrogenic factors, including:Tumor-related treatments,Surgery,Radiotherapy/Chemotherapy,Ovarian hyperstimulation from prior in vitro fertilization (IVF) cycles
3. Any of the following untreated or severe gynecological conditions:Unexplained irregular vaginal bleeding、Adnexal mass with a single largest diameter ≥ 4 cm、Stage III-IV endometriosis or bilateral ovarian endometriomas、Uterine fibroid(s) with a single largest diameter ≥ 4 cm、Endometrial polyp(s) with a single largest diameter \> 1.5 cm、Planned pelvic surgery during the trial period
4. Reduced menstrual flow (oligomenorrhea/hypomenorrhea) attributable to:Congenital uterine malformations、Uterine hypoplasia、Organic pathologies of the reproductive organs、Prior intrauterine procedures
5. Patients with severe diseases of the cardiovascular or cerebrovascular system, liver, kidney, hematopoietic system, or other major organ systems, as well as those with psychiatric disorders or intellectual disabilities.
6. Pregnancy or lactation.
7. Known allergy or hypersensitivity to any component of the investigational drugs in this study.
8. Participation in any other clinical trial within the 3 months preceding randomization.
9. Unwillingness to sign the informed consent form for this study.

Where this trial is running

Nanchang, Jiangxi

• The Second Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine — Nanchang, Jiangxi, China (Recruiting)

Study contacts

• Study coordinator: Ruining Liang

Conditions Diminished Ovarian Reserve