Traditional Chinese Medicine Sequential Treatment for Endometriosis Associated Infertility
关键词
抽象
描述
This study is a randomized, double-blind, placebo-controlled, multicenter, prospective clinical study, conducted in China (six research centers).
204 cases of patients with endometriosis-associated infertility confined with Syndrome of qi stagnation blood stasis pattern in TCM after conservative surgery will be recruited. Patients will be randomly divided into two groups: experimental group (TCM Sequential Treatment) and control group (placebo). All the patients are treated for six menstrual cycles, taking pre-ovulation decoction before ovulation and post-ovulation decoction after ovulation. Pre-ovulation decoction of experimental group is HuoXueXiaoYi decoction, and post-ovulation decoction is BuShenZhuYun decoction. The drug of control group is placebo.
Each menstrual cycle, patient is monitored of antral follicle count (AFC), ovulation, endometrial thickness, and endometrial blood flow by ultrasonography, and need fill TCM syndrome rating scale, pictorial blood loss assessment chart (PBAC), and the visual analogue scale(VAS).The 1st, 3rd, 6th menstrual cycle after surgery, the level of serum female hormone (FSH, LH, E2) are detected in menstrual period of 2 to 5 days, and female hormone (E2, P) in the middle of the corpus luteum 6-9 days.
Patient must be security check (blood routine, urine routine, liver and kidney function, electrocardiogram) before and after drug treatment. Such as patients find pregnancy during medication, adopt the security check in finding pregnancy 7 days.
Patients after amenorrhea need to be confirmed pregnancy by serum β-HCG detection. According to the level of serum HCG, E2 and P and clinical symptoms, corresponding tocolytic treatment will be given. At 6～8 weeks of pregnancy, patient need to be confirmed the clinical pregnancy by ultrasonography. If confirmed the clinical pregnancy (at least having one heart throb in intrauterine gestational sac), patient need to be confirmed ongoing pregnancy by ultrasonography at the 12～14 weeks of pregnancy.
In the process of the entire study, adverse events will be closely observed, and the frequency and severity of adverse events will be recorded.
日期
| 最后验证: | 01/31/2016 |
| 首次提交: | 08/15/2015 |
| 提交的预估入学人数: | 02/04/2016 |
| 首次发布: | 02/07/2016 |
| 上次提交的更新: | 02/16/2016 |
| 最近更新发布: | 02/18/2016 |
| 实际学习开始日期: | 11/30/2014 |
| 预计主要完成日期: | 04/30/2017 |
| 预计完成日期: | 11/30/2017 |
状况或疾病
干预/治疗
Drug: TCM Sequential Treatment
Drug: TCM Sequential Treatment
Drug: Placebo
Drug: Placebo
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: TCM Sequential Treatment After conservative surgery, patients start to take pre-ovulation decoction for 14 days. Each menstrual period 2～5 days, patients start to take pre-ovulation decoction. If ultrasonography found ovulation, change to take post-ovulation decoction. If having taken 14 days, ultrasonography found LUFS or no follicle develop maturity, change to take post-ovulation decoction. Taking post-ovulation decoction for 14 days, or continue to next time menstruation. Taking medication for six menstrual cycles.
Pre-ovulation decoction is HuoXueXiaoYi decoction, and post-ovulation decoction is BuShenZhuYun decoction. 2 bags each time, 2 times a day, fused with hot water, 1 hour after dinner.
All drugs are tcm formula granules, manufactured by Jiangyin Tianjiang Pharmaceutical Co. ltd | Drug: TCM Sequential Treatment HuoXueXiaoYi Decoction(Bupleurum 10g, Cyperus 10g, Salvia miltiorrhiza 20g, Red peony 10g,etc)has activating blood and absorbing clots effect, can inhibit the growth of ectopic endometrium, promote follicular growth, maturity, improve ovulation and the receptivity of endometrium. |
| Placebo Comparator: Placebo After conservative surgery, patients start to take pre-ovulation decoction(placebo) for 14 days. Each menstrual period 2～5 days, patients start to take pre-ovulation decoction. If ultrasonography found ovulation, change to take post-ovulation decoction. If having taken 14 days, ultrasonography found luteinized unruptured follicle syndrome (LUFS) or no follicle develop maturity, change to take post-ovulation decoction. Taking post-ovulation decoction(placebo) for 14 days, or continue to next time menstruation. Taking medication for six menstrual cycles. 2 bags each time, 2 times a day, fused with hot water, 1 hour after dinner.
Pre-ovulation decoction and post-ovulation decoction is placebo, manufactured by Jiangyin Tianjiang Pharmaceutical Co. ltd | Drug: Placebo Composition of maltodextrin, lactose, edible pigment, taste masking agent. |
资格标准
| 有资格学习的年龄 | 20 Years 至 20 Years |
| 有资格学习的性别 | Female |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: 1. Clinical diagnosis of endometriosis, infertility, with Syndrome of qi stagnation blood stasis pattern in TCM ; 2. The first time undergoing Laparoscopic or laparoscopy combined surgery , in lined with endometriosis-related infertility, tubal patency or obstruction lightly; 3. EFI score greater than 4 points; 4. Early follicular phase FSH≤10mIU / L; 5. 28 days of the menstrual cycle ± 7 days; 6. Female patients between 20-35 years old; 7. No previous history of severe drug allergies; 8. Past Three-month no taking hormone drugs such as danazol, Gestrinone, GnRHa; 9. No severe primary brain vascular diseases, liver, kidney and hematopoietic systems diseases, no history of mental illness, no drugs, alcohol, tobacco, caffeine dependent history; 10. Have signed informed consent Exclusion Criteria: 1. Associated with uterine fibroids, the diameter greater than 4cm, adenomyosis, pelvic tuberculosis, endometrial tuberculosis, intrauterine adhesions, polycystic ovary syndrome, hyperprolactinemia, thyroid dysfunction patients. 2. Serious history of drug allergy. 3. Male factor infertility. 4. The couple separated persons. |
结果
主要结果指标
1. Pregnancy rate [six menstrual cycles（each cycle is 28±7 days）]
次要成果指标
1. Clinical pregnancy rate (with intrauterine pregnancy sac) [at 6～8 weeks of pregnancy]
2. Clinical pregnancy rate (with a heart throb) [at 6～8 weeks of pregnancy]
3. Continued pregnancy rate [at the 12～14 weeks of pregnancy]
其他成果措施
1. Number of Participants With Treatment-emergent Adverse Events [six menstrual cycles（each cycle is 28±7 days）]
