Clinical trial NCT06089395: The Effect of Jiajian Guishen Granules on the Modulation of Ovarian Function in Patients With Poor Ovarian Response(POR)
Official title: A Randomized and Double-blind Clinical Trial of Jiajian Guishen Granules on the Modulation of Ovarian Function in Patients With Poor Ovarian Response
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Poor Ovarian Response
Keywords: Poor Ovarian Response
Ovarian function
Jiajian Guishen granules
Lead sponsor: Dongzhimen Hospital, Beijing
Sponsor class: OTHER
Collaborators: name: Capital Medical University
First posted: 2023-10-18
Enrollment: 76
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Stratified Block Group Randomized Controlled Study
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Woman who meet the diagnostic criteria for poor ovarian response;
2. Woman who meet the TCM diagnostic criteria for kidney deficiency;
3. Woman whose serum basal FSH(two consecutive menstrual cycles)between 10-25mIU/mL
4. Woman whose AMH \<1.1ng/ml;
5. Woman aged ranged from 20-45 years old
6. Woman whose body mass index (BMI)\<35 kg/m2
7. Womanwho voluntarily signed the informed consent form.

Exclusion Criteria:

1. Woman who have combination of serious diseases such as cardiovascular, cerebrovascular, hepatic, renal and hematopoietic systems, and malignant tumors;
2. Woman who have other endocrine diseases, such as polycystic ovary syndrome and hyperprolactinemia;
3. 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.
4. Woman who have used the same efficacy of herbs or other therapies in the last 1 month;
5. Woman who are allergic to the drugs used in this study.

Primary outcomes:
measure: Anti-Miller's Tube Hormone（AMH）
timeFrame: before treatment and the first menstrual period 2-4 days after treatment
Secondary outcomes:
measure: Follicle-stimulating hormone（FSH）
timeFrame: before treatment and the first menstrual period 2-4 days after treatment
measure: Luteinizing hormone（LH）
timeFrame: before treatment and the first menstrual period 2-4 days after treatment
measure: Estrogen (E2)
timeFrame: before treatment and the first menstrual period 2-4 days after treatment
measure: Progesterone (P)
timeFrame: before treatment and the first menstrual period 2-4 days after treatment
measure: Testosterone（T）
timeFrame: before treatment and the first menstrual period 2-4 days after treatment
measure: antral follicle count（AFC）
timeFrame: before treatment and early follicular phase in the first post-treatment menstrual cycle day 1
measure: Traditional Chinese Medicine Score
timeFrame: baseline and immediately after treatment
measure: Modified Kupperman rating scale
timeFrame: baseline and immediately after treatment
measure: Clinical pregnancy rate
timeFrame: up to 6 months
measure: Early miscarriage rate
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Dongzhimen Hospital of Beijing University of Chinese Medicine
state: Beijing
city: Beijing
country: China
facility: Chaoyang Hospital Affiliated to Capital Medical University
Study officials:
affiliation: Dongzhimen Hospital of Beijing University of Chinese Medicine
name: Shi Y Shi Yun, phD
role: STUDY_DIRECTOR
affiliation: Dongzhimen Hospital of Beijing University of Chinese Medicine
name: Wang CM Wang Chunmei, phD
role: PRINCIPAL_INVESTIGATOR
affiliation: Capital Medical University
name: Shi X Shi Xiao, phD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dongzhimen Hospital of Beijing University of Chinese Medicine
name: Yang QH Yang Qiaohui, pdD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dongzhimen Hospital of Beijing University of Chinese Medicine
name: Yan QY Yan Qingya, phD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dongzhimen Hospital of Beijing University of Chinese Medicine
name: Shao JY Shao Jingyi, Master
role: STUDY_CHAIR
affiliation: Dongzhimen Hospital of Beijing University of Chinese Medicine
name: Xu K Xu Ke, Master
role: STUDY_CHAIR
affiliation: Dongzhimen Hospital of Beijing University of Chinese Medicine
name: Li XY Li Xiyu, Bachelor
role: STUDY_CHAIR
affiliation: Dongzhimen Hospital of Beijing University of Chinese Medicine
name: Liu QY Liu Qinyang, Bachelor
role: STUDY_CHAIR
References: