Infertility Clinical Trial
Official title:
Activating Blood, Dredging Liver and Nourishing Kidney Sequential Treatment for Endometriosis Associated Infertility - a Randomized Double-blind Placebo Controlled Study
Endometriosis is a common, chronic disease. 30% to 50% of women with endometriosis are infertile. There is moderate quality evidence that laparoscopic surgery to treat mild and moderate endometriosis increases live birth or ongoing pregnancy rates. There was no evidence of benefit for post-surgical hormonal suppression of endometriosis compared to surgery alone for the outcomes of pregnancy rates. Past studies have confirmed that Chinese herbal medicine can inhibit post-surgical endometriosis recurrence, increase pregnancy rate.This study evaluates the efficacy and safety of Traditional Chinese Medicine Sequential Treatment of endometriosis-associated infertility. The study objective is to confirm that clinical pregnancy rate of patients with endometriosis-associated infertility post-conservative surgery accepting Chinese medicine activating blood, dredging liver and nourishing kidney sequential treatment is higher than expectant treatment.
Status | Recruiting |
Enrollment | 204 |
Est. completion date | December 2017 |
Est. primary completion date | May 2017 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 20 Years to 35 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Beijing Obstetrics and Gynecology Hospital,Captial Medical University | Beijing | Beijing |
China | GAMHospital | Beijing | Beijing |
China | Beijng Hospital | Beijng | |
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 | The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine | Hefei | Anhui |
Lead Sponsor | Collaborator |
---|---|
Guang'anmen Hospital of China Academy of Chinese Medical Sciences | Beijing Hospital, Guangdong Provincial Hospital of Traditional Chinese Medicine, Peking Union Medical College Hospital, The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine, The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine |
China,
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. Review. — View Citation
Yap C, Furness S, Farquhar C. Pre and post operative medical therapy for endometriosis surgery. Cochrane Database Syst Rev. 2004;(3):CD003678. Review. — View Citation
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 medici — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Number of Participants With Treatment-emergent Adverse Events | Treatment-emergent Adverse Events were assessed by CTCAE v4.0. | six menstrual cycles(each cycle is 28±7 days) | No |
Primary | Pregnancy rate | Pregnancy rate is defined as the proportion of participants finding pregnancy after amenorrhea and confirming serumß-HCG positive. | six menstrual cycles(each cycle is 28±7 days) | No |
Secondary | Clinical pregnancy rate (with intrauterine pregnancy sac) | defined as the proportion of participants confirmed there are at least one gestational sac in uterine cavity (No matter whether there is a heart throb) by ultrasonography. | at 6~8 weeks of pregnancy | No |
Secondary | Clinical pregnancy rate (with a heart throb) | defined as the proportion of participants confirmed at least having one heart throb in intrauterine gestational sac by ultrasonography. | at 6~8 weeks of pregnancy | No |
Secondary | Continued pregnancy rate | defined as the proportion of participants confirmed at least one live fetuses by ultrasonography. | at the 12~14 weeks of pregnancy | No |
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