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New treatment option for Diminished Ovarian Reserve
Official title A Randomized Controlled Trial of Combined Bu Shen Yi Qi Decoction and Dehydroepiandrosterone (DHEA) for the Treatment of Ovarian Function Decline
ClinicalTrials.gov ID: NCT07535983
What this study is testing
What is Bushen formula combined with dehydroepiandrosterone?
Bushen formula combined with dehydroepiandrosterone is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for diminished ovarian reserve.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 to 40, women only. Healthy volunteers may be eligible.
You may be able to join if
- 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.
You likely can't join if
- Concurrent reproductive endocrine, metabolic, or immune system disorders that could affect ovarian reserve or confound the evaluation of treatment...
- Diminished ovarian reserve (DOR) attributable to iatrogenic factors, including:Tumor-related treatments,Surgery,Radiotherapy/Chemotherapy,Ovarian...
- Any of the following untreated or severe gynecological conditions:Unexplained irregular vaginal bleeding、Adnexal mass with a single largest diameter...
- Reduced menstrual flow (oligomenorrhea/hypomenorrhea) attributable to:Congenital uterine malformations、Uterine hypoplasia、Organic pathologies of the...
- Patients with severe diseases of the cardiovascular or cerebrovascular system, liver, kidney, hematopoietic system, or other major organ systems, as...
- Pregnancy or lactation.
See the full eligibility 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.
- Concurrent reproductive endocrine, metabolic, or immune system disorders that could affect ovarian reserve or confound the evaluation of treatment how well it works, including:Polycystic ovary...
- 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...
- 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.
- Unwillingness to sign the informed consent form for this study.
The study team makes the final eligibility decision.
Where it's taking place
- Nanchang, Jiangxi, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 20 years to 40 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanchang, Jiangxi, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.