Traditional Chinese Medicine Sequential Treatment for Endometriosis Associated Infertility
NCT ID: NCT02676713
Last Updated: 2016-02-19
Study Results
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Basic Information
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UNKNOWN
PHASE2
204 participants
INTERVENTIONAL
2014-12-31
2017-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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
pre-ovulation Decoction
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.
post-ovulation Decoction
BuShenZhuYun Decoction(Bupleurum 10g,Poria 15g, Atractylodes 15g,Ligustrum 15g,etc) has dredging liver and nourishing kidney effect, can improve the function of corpus luteum.
All are made into granules.
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
pre-ovulation Decoction(placebo)
Composition of maltodextrin, lactose, edible pigment, taste masking agent.
post-ovulation Decoction(placebo)
Composition of maltodextrin, lactose, edible pigment, taste masking agent.
Interventions
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pre-ovulation Decoction
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.
post-ovulation Decoction
BuShenZhuYun Decoction(Bupleurum 10g,Poria 15g, Atractylodes 15g,Ligustrum 15g,etc) has dredging liver and nourishing kidney effect, can improve the function of corpus luteum.
All are made into granules.
pre-ovulation Decoction(placebo)
Composition of maltodextrin, lactose, edible pigment, taste masking agent.
post-ovulation Decoction(placebo)
Composition of maltodextrin, lactose, edible pigment, taste masking agent.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
2. Serious history of drug allergy.
3. Male factor infertility.
4. The couple separated persons.
20 Years
35 Years
FEMALE
No
Sponsors
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Peking Union Medical College Hospital
OTHER
Beijing Hospital
OTHER_GOV
Guangdong Provincial Hospital of Traditional Chinese Medicine
OTHER
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
OTHER
The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
OTHER
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
OTHER
Responsible Party
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Zhao RuiHua
Chief Physician
Principal Investigators
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Ruihua Zhao, Doctor
Role: STUDY_CHAIR
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Locations
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The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
Hefei, Anhui, China
Beijing Obstetrics and Gynecology Hospital,Captial Medical University
Beijing, Beijing Municipality, China
GAMHospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
Guangzhou, Guangdong, China
Traditional Chinese Medicine Hospital of Guangdong Province
Guangzhou, Guangdong, China
Beijng Hospital
Beijng, , China
Countries
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Central Contacts
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Jie Wang, Doctor
Role: CONTACT
Facility Contacts
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Weili Li, PHD
Role: primary
Dan Lu, PHD
Role: primary
Cheng Zeng, PHD
Role: primary
Xiaoyun Wang, PHD
Role: primary
Qingwei Meng, PHD
Role: primary
References
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Duffy JM, Arambage K, Correa FJ, Olive D, Farquhar C, Garry R, Barlow DH, Jacobson TZ. Laparoscopic surgery for endometriosis. Cochrane Database Syst Rev. 2014 Apr 3;(4):CD011031. doi: 10.1002/14651858.CD011031.pub2.
Yap C, Furness S, Farquhar C. Pre and post operative medical therapy for endometriosis surgery. Cochrane Database Syst Rev. 2004;2004(3):CD003678. doi: 10.1002/14651858.CD003678.pub2.
Zhao RH, Hao ZP, Zhang Y, Lian FM, Sun WW, Liu Y, Wang R, Long L, Cheng L, Ding YF, Song DR, Meng QW, Wang AM. Controlling the recurrence of pelvic endometriosis after a conservative operation: comparison between Chinese herbal medicine and western medicine. Chin J Integr Med. 2013 Nov;19(11):820-5. doi: 10.1007/s11655-012-1247-z. Epub 2012 Dec 22.
Zhao RH, Liu Y, Lu D, Wu Y, Wang XY, Li WL, Zeng C, Meng QW, Lian FM, Zhou J, Shi Y, Sun WW, Han Q, Tang Y, Shi G. Chinese Medicine Sequential Therapy Improves Pregnancy Outcomes after Surgery for Endometriosis-Associated Infertility: A Multicenter Randomized Double-blind Placebo Parallel Controlled Clinical Trial. Chin J Integr Med. 2020 Feb;26(2):92-99. doi: 10.1007/s11655-019-3208-2. Epub 2020 Jan 29.
Other Identifiers
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2014BAI10B08
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
GAMHospital
Identifier Type: -
Identifier Source: org_study_id
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