The Effect of Jiajian Guishen Granules on the Modulation of Ovarian Function in Patients With Poor Ovarian Response(POR)

Study Overview
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Brief Summary
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Relying on the Department of Gynecology of Dongzhimen Hospital of Beijing University of Traditional Chinese Medicine and Xiyuan Hospital of China Academy of Traditional Chinese Medicine, 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 60 patients with POR were collected and stratified district groups were randomly divided into a test group and a control group, with 30 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
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This study was a multicenter, stratified block randomized, double-blind, double simulation, positive controlled clinical trial.

Official Title
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A Randomized and Double-blind Clinical Trial of Jiajian Guishen Granules on the Modulation of Ovarian Function in Patients With Poor Ovarian Response

Conditions
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Poor Ovarian Response

Intervention / Treatment
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* Drug: Jiajian Guishen granules
* Drug: coenzyme Q10


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Those who meet the diagnostic criteria for poor ovarian response; Those who meet the TCM diagnostic criteria for kidney deficiency; 20 years old ≤ age ≤ 45 years old; Those who voluntarily signed the informed consent form. Exclusion Criteria: Abnormalities in the reproductive function of the spouse; Patients with congenital abnormalities of gonadal development or a family history of early menopause; Infertility caused by tubal or uterine factors; Combined cardiovascular, cerebrovascular, hepatic, renal and hematopoietic systems, malignant tumors and other serious diseases; Excluding other endocrine diseases, such as polycystic ovary syndrome, hyperprolactinemia and so on; Those 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； Those who have used the same efficacy of traditional Chinese medicine or other therapies in the last 1 month; Those who are allergic to the drugs used in this study.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A Stratified Block Group Randomized Controlled Study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Jiajian Guishen granules group<br>Jiajian Guishen granules + coenzyme Q10 simulant | Drug: Jiajian Guishen granules<br>* This study was a stratified district group randomized, double-blind, double simulation, positive control clinical trial with JJGS granules + coenzyme Q10 simulant in the test group and JJGS granules simulant + coenzyme Q10 in the control group<br>* Other names: JJGS;|
| Active Comparator: coenzyme Q10 group<br>Jiajian Guishen granules simulant+ coenzyme Q10 | Drug: coenzyme Q10<br>* This study was a stratified district group randomized, double-blind, double simulation, positive control clinical trial with JJGS granules + coenzyme Q10 simulant in the test group and JJGS granules simulant + coenzyme Q10 in the control group<br>* Other names: CoQ10;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-Miller's Tube Hormone（AMH） | 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 | before treatment and the first menstrual period 2-4 days after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Follicle-stimulating hormone（FSH） | The unit is mIU/mL.Elbow vein blood was collected on an empty stomach, and after separating the serum, FSH were measured by radioimmunoassay. | before treatment and the first menstrual period 2-4 days after treatment | 
| Luteinizing hormone（LH） | The unit is mIU/mL.Elbow vein blood was collected on an empty stomach, and after separating the serum, LH were measured by radioimmunoassay. | before treatment and the first menstrual period 2-4 days after treatment | 
| Estrogen (E2) | The unit is pg/mL.Elbow vein blood was collected on an empty stomach, and after separating the serum, E2 were measured by radioimmunoassay. | before treatment and the first menstrual period 2-4 days after treatment | 
| Progesterone (P) | The unit is ng/mL.Elbow vein blood was collected on an empty stomach, and after separating the serum, P were measured by radioimmunoassay. | before treatment and the first menstrual period 2-4 days after treatment | 
| Testosterone（T） | The unit is ng/mL.Elbow vein blood was collected on an empty stomach, and after separating the serum, T were measured by radioimmunoassay. | before treatment and the first menstrual period 2-4 days after treatment | 
| antral follicle count（AFC） | Color Doppler ultrasound was performed in the early follicular phase in the usual way to observe the number of follicles in the underlying sinuses. | before treatment and early follicular phase in the first post-treatment menstrual cycle day 1 | 
| Traditional Chinese Medicine Score | 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. | baseline and immediately after treatment | 
| Modified Kupperman rating scale | 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. | baseline and immediately after treatment | 
| Clinical pregnancy rate | 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. | up to 6 months | 
| Early miscarriage rate | Defined as the per-centage of participants with loss of a diagnosed clinical pregnancy before 12 weeks gestation to the total patients randomized | up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Poor Ovarian Response, Ovarian function, Jiajian Guishen granules