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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: Ruining Liang
• Email: jack169@sina.com
• Phone: 0086-0791-88385243

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.