The Effect of Jiajian Guishen Granules on the Modulation of Ovarian Function in Patients With Poor Ovarian Response(POR)
- Conditions
- Poor Ovarian Response
- Interventions
- Drug: Jiajian Guishen granules
- Registration Number
- NCT06089395
- Lead Sponsor
- Shi Yun
- Brief Summary
Relying on the Department of Gynecology of Dongzhimen Hospital of Beijing University of Traditional Chinese Medicine and chaoyang hospital of Capital medical university, this randomized controlled clinical study was carried out to investigate the application of kidney tonifying herbs to patients with poor ovarian response（POR）.
A total of 76 patients with POR were collected and stratified district groups were randomly divided into a test group and a control group, with 38 patients included in each group. The experimental group was intervented with JJGS granules + coenzyme Q10 simulant, and the control group was intervened with coenzyme Q10 + JJGS granules simulant. AMH, serum basal sex hormone, AFC, TCM syndrome score, modified Kupperman scale and pregnancy status were observed before and after treatment to investigate the effects of Jiajian Guishen granules on the ovarian function of POR patients.
- Detailed Description
This study was a multicenter, stratified block randomized, double-blind, double simulation, positive controlled clinical trial.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 76
- Woman who meet the diagnostic criteria for poor ovarian response;
- Woman who meet the TCM diagnostic criteria for kidney deficiency;
- Woman whose serum basal FSH(two consecutive menstrual cycles)between 10-25mIU/mL
- Woman whose AMH <1.1ng/ml;
- Woman aged ranged from 20-45 years old
- Woman whose body mass index (BMI)<35 kg/m2
- Womanwho voluntarily signed the informed consent form.
- Woman who have combination of serious diseases such as cardiovascular, cerebrovascular, hepatic, renal and hematopoietic systems, and malignant tumors;
- Woman who have other endocrine diseases, such as polycystic ovary syndrome and hyperprolactinemia;
- Woman who are unable to cooperate with the treatment and follow-up, such as combined neurological and psychiatric disorders, or those who are unwilling to cooperate.
- Woman who have used the same efficacy of herbs or other therapies in the last 1 month;
- Woman who are allergic to the drugs used in this study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Jiajian Guishen granules group Jiajian Guishen granules Jiajian Guishen granules + coenzyme Q10 simulant coenzyme Q10 group coenzyme Q10 Jiajian Guishen granules simulant+ coenzyme Q10
- Primary Outcome Measures
Name Time Method Anti-Miller's Tube Hormone（AMH） 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 Outcome Measures
Name Time Method Progesterone (P) 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, P were measured by radioimmunoassay.
Follicle-stimulating hormone（FSH） before treatment and the first menstrual period 2-4 days after treatment The unit is mIU/mL.Elbow vein blood was collected on an empty stomach, and after separating the serum, FSH were measured by radioimmunoassay.
Testosterone（T） 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, T were measured by radioimmunoassay.
Estrogen (E2) before treatment and the first menstrual period 2-4 days after treatment The unit is pg/mL.Elbow vein blood was collected on an empty stomach, and after separating the serum, E2 were measured by radioimmunoassay.
antral follicle count（AFC） before treatment and early follicular phase in the first post-treatment menstrual cycle day 1 Color Doppler ultrasound was performed in the early follicular phase in the usual way to observe the number of follicles in the underlying sinuses.
Luteinizing hormone（LH） before treatment and the first menstrual period 2-4 days after treatment The unit is mIU/mL.Elbow vein blood was collected on an empty stomach, and after separating the serum, LH were measured by radioimmunoassay.
Traditional Chinese Medicine Score baseline and immediately after treatment The main symptoms include menstrual cycle, menstrual flow reduction. Scoring criteria: ① normal menstrual cycle 0 points, 1-2 weeks ahead or behind the wrong 4 points, 2-3 weeks 8 points, more than 3 weeks 12 points; ② menstrual flow than the previous menstrual flow no change 0 points, menstrual flow reduction ≤ ⅓ 4 points, ⅓ \< menstrual flow reduction ≤ ½ 8 points, menstrual flow reduction \> ½ 12 points. Secondary symptoms included lumbar and knee pain, dizziness and tinnitus, loss of libido, increased urination, hot flashes and night sweats, and lower back and lower limb pain. According to the degree of aggravation of symptoms, the total score was assigned as 0,2,4,8. The sum of the scores of the main symptoms and secondary symptoms, the higher the score, the more serious the TCM symptoms.
Modified Kupperman rating scale baseline and immediately after treatment Referring to the domestic modified Kupperman Symptom Scoring Criteria in Chinese Obstetrics and Gynecology, edited by Cao Zeyi, to observe and rate perimenopausal symptoms before and after treatment and to quantify the degree of decline in ovarian function.Entries include hot flashes and sweating, sensory abnormalities, insomnia, anxiety and depression, dizziness, fatigue, muscle and joint pain, headache, palpitations, ankylosis of the skin, sexual discomfort, and urinary irritation, with different coefficients for each entry, and according to the aggravating degree of the symptom, they are divided into 0, 1, 2, and 3 points, and the coefficients corresponding to the scoring of the degree of each item are multiplied by a fixed score of the symptom to add up to the total score, and the higher the total score suggests that the symptoms of the perimenopausal period are more serious.
Clinical pregnancy rate up to 6 months Defined as the number of women with identified clinical pregnancies divided by the number of patients randomized to a specific group. Clinical pregnancy is confirmed when 1 or more ges-tational sacs are detected on transvaginal ultrasound assessment.
Early miscarriage rate up to 6 months Defined as the per-centage of participants with loss of a diagnosed clinical pregnancy before 12 weeks gestation to the total patients randomized
Trial Locations
- Locations (2)
Dongzhimen Hospital of Beijing University of Chinese Medicine
🇨🇳Beijing, Beijing, China
Chaoyang Hospital Affiliated to Capital Medical University
🇨🇳Beijing, China