A Randomized Controlled Trial of Combined Bu Shen Yi Qi Decoction and Dehydroepiandrosterone (DHEA) for the Treatment of Ovarian Function Decline

Phase 2RecruitingNCT07535983

Jiangxi University of Traditional Chinese Medicine74 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Diminished Ovarian Reserve

Interventions

Bushen formula combined with dehydroepiandrosteroneDRUG

Patients in the treatment group received the Bushen Yiqi Formula (composed of Rehmanniae Radix Praeparata (Shu Di Huang), Rehmanniae Radix (Sheng Di Huang), Glehniae Radix (Bei Sha Shen), Ophiopogonis Radix (Mai Dong), Asini Corii Colla (E Jiao), Dioscoreae Rhizoma (Shan Yao), Testudinis Carapax et Plastrum (Gui Ban), Cuscutae Semen (Tu Si Zi), Morindae Officinalis Radix (Ba Ji Tian), etc.). The herbal formula was provided as a fine granule for oral administration.Herbal Formula: Starting from the first day of inclusion, subjects took the granulated herbs dissolved in hot water, twice daily, with 2 sachets per dose. The treatment course lasted for 12 weeks.All participants (in both the treatment and control groups) concurrently took dehydroepiandrosterone (DHEA) tablets (25 mg per tablet; Fosun Pharma, USA) at a dosage of 25 mg three times daily.

Placebo combined with dehydroepiandrosteroneDRUG

The control group received matching placebo preparations. To ensure blinding, both the herbal formula for the treatment group and the placebo for the control group were identically packaged, with indistinguishable appearance, odor, and color.All participants (in both the treatment and control groups) concurrently took dehydroepiandrosterone (DHEA) tablets (25 mg per tablet; Fosun Pharma, USA) at a dosage of 25 mg three times daily.

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

AMH

Serum anti-Müllerian hormone (AMH) levels will be measured to assess ovarian reserve function. Changes in AMH levels from baseline to post-treatment and follow-up will be compared between the treatment group and the control group.

Time frame: 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.