A Randomized and Double-blind Clinical Trial of Guishen Yijing Granules on the Modulation of Ovarian Function in Patients With Diminished Ovarian Reserve
Trial Snapshot
- Phase
- Phase 1
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 120
- Primary Endpoint
- Anti-Miller's Tube Hormone（AMH）
Study Overview
Brief Summary
This study is a multicenter, stratified block-randomized, double-blind, double-dummy clinical trial designed to evaluate the efficacy and safety of Guishen Yijing Granules in patients with diminished ovarian reserve (DOR) and kidney deficiency syndrome through multidimensional assessment of clinical outcomes before and after treatment.
A total of 120 patients with DOR will be recruited from the gynecology outpatient departments of Dongzhimen Hospital, Beijing University of Chinese Medicine; Xiyuan Hospital, China Academy of Chinese Medical Sciences; and Beijing Chaoyang Hospital, Capital Medical University. Participants will be randomly assigned in a 1:1 ratio to the experimental group or the control group, with 60 participants in each group.
Participants in the experimental group will receive Guishen Yijing Granules plus a coenzyme Q10 placebo, whereas those in the control group will receive coenzyme Q10 plus a Guishen Yijing Granules placebo. Treatment will begin on day 5 of the menstrual cycle. For participants with amenorrhea, treatment will begin after pregnancy has been excluded. Each treatment cycle will consist of 21 consecutive days of medication. If menstruation occurs after completion of a treatment cycle, the next treatment cycle will begin on day 5 of the subsequent menstrual cycle. If menstruation does not occur, participants will discontinue treatment for 7 days after pregnancy has been excluded and then begin the next treatment cycle according to the same regimen. Treatment will continue for three menstrual cycles; participants with amenorrhea will receive treatment for 3 months.
Outcomes assessed before and after treatment will include basal serum follicle-stimulating hormone (FSH), luteinizing hormone (LH), and estradiol (E2) levels, anti-Müllerian hormone (AMH), antral follicle count (AFC), traditional Chinese medicine syndrome scores, and modified Kupperman Index scores. The study aims to evaluate the efficacy and safety of Guishen Yijing Granules and their effects on ovarian function in patients with DOR.
Detailed Description
This study was a multicenter, stratified block randomized, double-blind, double simulation clinical trial.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 25 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •(1) fulfillment of the diagnostic criteria for diminished ovarian reserve; (2) fulfillment of the Traditional Chinese Medicine pattern differentiation criteria for kidney deficiency syndrome; (3) age between 25 and 45 years (25 ≤ age < 45); (4) baseline follicle-stimulating hormone level between 10 and 25 IU/L (10 IU/L ≤ baseline FSH < 25 IU/L); and (5) voluntary provision of written informed consent after being fully informed of the study details.
Exclusion Criteria
- •(1) pregnancy or lactation; (2) comorbidities involving severe conditions of the cardiovascular, cerebrovascular, or hematopoietic systems, or malignant tumors; (3) primary amenorrhea or a family history of early menopause; (4) diminished ovarian reserve caused by ovarian or related surgery; (5) mental disorders or intellectual disability; (6) use of hormonal medications within the past 3 months; or (7) concurrent participation in other clinical trials.
Arms & Interventions
Guishen Yijing Granules Group
Guishen Yijing Granules
Intervention: Guishen Yijing Granules (Drug)
coenzyme Q10 group
coenzyme Q10
Intervention: Coenzyme Q10 (drug) (Drug)
Outcomes
Primary Outcomes
Anti-Miller's Tube Hormone（AMH）
Time Frame: before treatment and the first menstrual period 2-4 days after treatment
The unit is ng/mL.Elbow vein blood was collected on an empty stomach, and after separating the serum, anti-mullerian hormone (AMH) was measured by radioimmunoassay
Secondary Outcomes
- Follicle-stimulating hormone（FSH）(before treatment and the first menstrual period 2-4 days after treatment)
- Luteinizing hormone（LH）(before treatment and the first menstrual period 2-4 days after treatment)
- Estrogen (E2)(before treatment and the first menstrual period 2-4 days after treatment)
- Progesterone (P)(before treatment and the first menstrual period 2-4 days after treatment)
- Testosterone（T）(before treatment and the first menstrual period 2-4 days after treatment)
- antral follicle count（AFC）(before treatment and on days 2-4 of the early follicular phase in the first post-treatment menstrual cycle)
- Traditional Chinese Medicine Score(baseline and immediately after treatment)
- Modified Kupperman rating scale(baseline and immediately after treatment)
Investigators
Shi Yun
Chief of Gynecology
Dongzhimen Hospital, Beijing