Non-inferiority Randomized Controlled Study on Kidney Tonifying and Blood Circulation Regulating Therapy (Bu Shen Tiao Xue) of Different Intervention Courses in Improving IVF-ET Pregnancy Outcomes in DOR Patients
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 266
- 主要终点
- Number of oocytes retrieved
研究概览
简要总结
Patients with diminished ovarian reserve (DOR) who undergo in vitro fertilization and embryo transfer (IVF-ET) are included as the research subjects. The effects of Traditional Chinese Medicine (TCM) for kidney tonifying and blood circulation regulating of different intervention courses on ovarian hyporesponsiveness, IVF-ET outcome and clinical compliance in DOR patients are studied by a non-inferiority randomized controlled trial. The purpose is to identify the breakthrough point and treatment timing of TCM treatment, explore the best treatment course of TCM, and optimize the TCM therapeutic regimen.
详细描述
IVF-ET is one of the major techniques to treat infertility in DOR patients, but poor ovarian response and low pregnancy rate have been the bottleneck problems. China has original advantages in Traditional Chinese Medicine (TCM) treatment. The kidney tonifying and blood circulation regulating therapy is a pre-IVF-ET intervention treatment characterized by sequential treatment according to menstrual cycle formed in the previous investigations by the research group. It can ameliorate ovarian hyporesponsiveness and improve the success rate of IVF-ET, but the compliance is poor due to the long intervention course. Identifying the time point of TCM intervention to further optimize the treatment plan is the key to improving the pregnancy rate. Therefore, DOR patients who receive IVF-ET are enrolled as the research objects in this project, who are divided into the experimental group and control group with a randomized controlled non-inferiority design, and receive sequential TCM therapy for kidney tonifying and blood circulation regulating from the fifth day of menstruation at the second menstrual cycle and the third menstrual cycle prior to IVF-ET, respectively, until the day of human chorionic gonadotrophin (hCG) administration. The number of oocytes retrieved, the rate of high-quality embryos, the dosage and administration days of Gn, the levels of estradiol (E2) and progesterone (P) and the clinical pregnancy rate on hCG day are compared between the two groups. Meanwhile, the compliance of patients in the two groups with different treatment regimens is compared. This project aims to verify that the efficacy of the treatment plan implemented from the second menstrual cycle prior to IVF-ET may not be inferior to that from the third menstrual cycle prior to IVF-ET on improving the pregnancy outcomes of DOR patients, while the compliance is better. The results of the study will provide a reference basis for the precise treatment of TCM prior to IVF-ET.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 20 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female, 20 years old ≤ age ≤ 42 years old;
- •The menstrual cycle is generally regular; 21 days < menstrual cycle < 35 days;
- •Those who meet the diagnostic criteria for DOR in Western medicine;
- •Those who meet the TCM differential criteria of kidney deficiency syndrome;
- •Those who are scheduled to undergo IVF-ET;
- •Those who voluntarily participate in this clinical trial and sign a written informed consent.
排除标准
- •Those who have a history of two or more spontaneous abortions (excluding biochemical pregnancy abortion) or three or more previous transplantations without achieving clinical pregnancy;
- •Those who have premature ovarian failure or ovarian gonadotropin resistance syndrome;
- •Those who have untreated uterine malformation or abnormality: double uterus, septate uterus (complete or incomplete);
- •Those who have untreated unilateral or bilateral hydrosalpinx;
- •Those who have uncured endometrial diseases (such as endometritis, endometrial polyps, endometriosis), adenomyosis, intrauterine adhesions, etc., and those with uterine fibroids of more than 4 cm;
- •Those who have endocrine diseases such as polycystic ovary syndrome, hyperprolactinemia, hyperandrogenism, hypothyroidism, abnormal adrenal function, etc., which affect ovulation;
- •Infertile patients with abnormal ovarian function caused by immunological factors, genetic factors or congenital physiological defects;
- •Those who have received pelvic radiotherapy;
- •Those who are known or suspected of having sex hormone-related malignant tumors;
- •Those who are allergic or intolerable to the medications involved in the study;
- •Those with contraindications to assisted reproductive technology or pregnancy, such as uncontrolled abnormal liver and renal function, diabetes, hypertension, thyroid disease, symptomatic heart disease, moderate to severe anemia, history of malignant tumor or history of thromboembolism or thrombosis formation tendency, serious mental illness, acute infection of urogenital system, sexually transmitted disease, extremely bad habits such as drug use, exposure to teratogenic radiation, poison, drugs (such as prednisone and other hormones, epinephrine, antibiotics, antihypertensive drugs, cardiovascular and cerebrovascular drugs, antiviral drugs) and are still under the effect of the drugs; and those whose uterus is unable to perform the function of pregnancy or who are intolerant of pregnancy due to physical diseases during pregnancy;
- •Those who have taken other TCMs or proprietary Chinese medicines that can invigorate the kidney or affect the evaluation of drug efficacy in the past 30 days;
- •Other patients who are deemed unsuitable to participate in this study by the researchers;
- •Those who are participating in other clinical trials;
- •Those who do not agree to participate in this study or do not sign the informed consent form.
研究组 & 干预措施
administration for 2 menstrual cycles group
This group will receive TCM treatment before 2 menstrual cycles of IVF-ET.
干预措施: Medical prescription before ovulation (Drug)
administration for 2 menstrual cycles group
This group will receive TCM treatment before 2 menstrual cycles of IVF-ET.
干预措施: Medical prescription after ovulation (Drug)
administration for 3 menstrual cycles group
This group will receive TCM treatment before 3 menstrual cycles of IVF-ET.
干预措施: Medical prescription before ovulation (Drug)
administration for 3 menstrual cycles group
This group will receive TCM treatment before 3 menstrual cycles of IVF-ET.
干预措施: Medical prescription after ovulation (Drug)
结局指标
主要结局
Number of oocytes retrieved
时间窗: up to 15 weeks from enrollment
The number of oocytes retrieved by puncture under the guidance of vaginal ultrasound
次要结局
- Levels of AMH(up to 15 weeks from enrollment)
- Health economics indicators(up to 15 weeks from enrollment)
- High-quality embryo rate (%)(up to 15 weeks from enrollment)
- Clinical pregnancy rate(up to 15 weeks from enrollment)
- Compliance with the treatment plan(up to 15 weeks from enrollment)
- Gonadotrophin (Gn) administration day(up to 15 weeks from enrollment)
- Gn dosage(up to 15 weeks from enrollment)
- Levels of LH(up to 15 weeks from enrollment)
- Levels of E2(up to 15 weeks from enrollment)
- Levels of P(up to 15 weeks from enrollment)
- Antral follicle count (AFC)(up to 15 weeks from enrollment)
- Levels of FSH(up to 15 weeks from enrollment)