A Randomized Controlled Trial of Combined Bu Shen Yi Qi Decoction and Dehydroepiandrosterone (DHE… (NCT07535983) | Clinical Trial Compass
RecruitingPhase 1/2
A Randomized Controlled Trial of Combined Bu Shen Yi Qi Decoction and Dehydroepiandrosterone (DHEA) for the Treatment of Ovarian Function Decline
China74 participantsStarted 2025-09-01
Plain-language summary
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
Who can participate
Age range
20 Years – 40 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients who meet both the Western medical diagnostic criteria for DOR and the Traditional Chinese Medicine (TCM) diagnostic criteria.
. Female patients aged 20-40 years (inclusive).
. No use of estrogen or progestin medications within the past three months.
. Voluntary participation in this study, with informed consent provided and a written informed consent form signed.
Exclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
AMH
Timeframe: Blood samples were collected on days 2-4 of the menstrual cycle at three predefined time points: (1) baseline, (2) the first menstrual cycle after treatment, and (3) the first menstrual cycle following the 3-month follow-up period.
Trial details
NCT IDNCT07535983
SponsorJiangxi University of Traditional Chinese Medicine
. Diminished ovarian reserve (DOR) attributable to iatrogenic factors, including:Tumor-related treatments,Surgery,Radiotherapy/Chemotherapy,Ovarian hyperstimulation from prior in vitro fertilization (IVF) cycles
. 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
. Reduced menstrual flow (oligomenorrhea/hypomenorrhea) attributable to:Congenital uterine malformations、Uterine hypoplasia、Organic pathologies of the reproductive organs、Prior intrauterine procedures
. 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.
. Pregnancy or lactation.
. Known allergy or hypersensitivity to any component of the investigational drugs in this study.
. Participation in any other clinical trial within the 3 months preceding randomization.