Back to resultsEffect of Acupuncture on Incomplete Fallopian Tube Obstructive Infertility: Study Protocol for Trial
Primary Purpose
Female Infertility Due to Occlusion of Fallopian Tube
Status
Unknown status
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Female Infertility Due to Occlusion of Fallopian Tube focused on measuring hydrotubation, incomplete fallopian tube obstructive infertility, Acupuncture
Eligibility Criteria
Inclusion Criteria:
- I.Patients between 22 and 42 years of age with infertility II.diagnosis of incomplete Fallopian tube obstruction based on one of the following conditions: a. Tubal patency test: Hydrotubation , Hysterosalpingography (HSG) or Hysterosonosalpingography (HSS) shows incomplete bilateral Fallopian tube obstruction b. Hysteroscopy: Hysteroscopic tubal cannulation hydrotubation proves bilateral tube incompletely patent. c. Laparoscopy: incomplete bilateral tubal obstruction can be displayed by the methylene blue solution through the tubes III.Other relative treatments are not carried out within two weeks IV.willing to cooperate with us V. mean infertility time is 1-5 years.
Exclusion Criteria:
- I.allergic constitution or be allergic to diatrizoate or a variety of drugs II.the infertility is not leaded by tubal obstruction ,such as Congenital Physiological defects or malformation, genetic factors, immune factors and endocrine factors III.diagnosed with uterine lesions by auxiliary examinations (endometriosis ,adenomyosis , hysteromyoma or cancer and so on ) and infertility caused by tubal tuberculosis IV. infertility factor in their male partner V.people with Serious primary diseases of cardiovascular, liver, kidney and hematopoietic systems ,patients with mental illness VI.unable to judge the therapeutic efficacy or incomplete information VII.complete bilateral tubal obstruction VIII.bilateral tubes patent IX.Not willing to give written consent to the study X. people who are pregnant XI.people with acute infection .
Sites / Locations
- LiLiuRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
True acupuncture plus hydrotubation
control acupuncture plus hydrotubation
Arm Description
The treatment group will receive true acupuncture and hydrotubation,Hydrotubation (80,000 U gentamicin , 400U chymotrypsin , 5mg dexamethasone , 50ml 0.9% saline) will be performedwithin 3 7 days after the menstruation[12].We use a manometer to measure the pressure and record the number on a card, then calculate the gap of the first and last time,it continues 3 menstrual cycles. The points (points used for every participant of treatment group) include bilateral RN4、CV6、CV3、EX-CA1、ST36、SP6,All the needles will be keep in positions for 30 min.Acupuncture will be performed three times per week,for a total of 36 sessions (12 wk)
The control group will receive control acupuncture and hydrotubation.Hydrotubation (80,000 U gentamicin , 400U chymotrypsin , 5mg dexamethasone , 50ml 0.9% saline) will be performed within 3 7 days after the menstruation[12].We use a manometer to measure the pressure and record the number on a card, then calculate the gap of the first and last time,it continues 3 menstrual cycles.Two needles will be inserted in each arm, one in each shoulder and one in each upper arm at nonacupuncture pointsAll the needles will be keep in positions for 30 min. Acupuncture will be performed three times per week,for a total of 36 sessions (12 wk).
Outcomes
Primary Outcome Measures
tubal patency rate
Secondary Outcome Measures
pregnancy rate
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02320006
Brief Title
Effect of Acupuncture on Incomplete Fallopian Tube Obstructive Infertility: Study Protocol for Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Unknown status
Study Start Date
December 2014 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Li Liu
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Acupuncture is one of the traditional Chinese practices widely used in China for more than 3000 years. In recent years, the use of acupuncture within infertility has gained popularity all over the world, but there is no research describing the use of acupuncture in infertility of incompletely obstructive fallopian tube. In this paper, we present a research design evaluating the effects of acupuncture on incomplete fallopian tube obstructive infertility. This is a randomized, control acupuncture and signal-blind trial. A total of 120 patients will be enrolled in this study and will be randomized into two groups. True acupuncture plus hydrotubation or control acupuncture plus hydrotubation will be performed for 12 weeks. The purpose of this paper is to evaluate the additional value of acupuncture on the tubal patency rate and pregnancy rate beyond Hydrotubation ,therefore to guide clinical.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Female Infertility Due to Occlusion of Fallopian Tube
Keywords
hydrotubation, incomplete fallopian tube obstructive infertility, Acupuncture
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
True acupuncture plus hydrotubation
Arm Type
Active Comparator
Arm Description
The treatment group will receive true acupuncture and hydrotubation,Hydrotubation (80,000 U gentamicin , 400U chymotrypsin , 5mg dexamethasone , 50ml 0.9% saline) will be performedwithin 3 7 days after the menstruation[12].We use a manometer to measure the pressure and record the number on a card, then calculate the gap of the first and last time,it continues 3 menstrual cycles. The points (points used for every participant of treatment group) include bilateral RN4、CV6、CV3、EX-CA1、ST36、SP6,All the needles will be keep in positions for 30 min.Acupuncture will be performed three times per week,for a total of 36 sessions (12 wk)
Arm Title
control acupuncture plus hydrotubation
Arm Type
Sham Comparator
Arm Description
The control group will receive control acupuncture and hydrotubation.Hydrotubation (80,000 U gentamicin , 400U chymotrypsin , 5mg dexamethasone , 50ml 0.9% saline) will be performed within 3 7 days after the menstruation[12].We use a manometer to measure the pressure and record the number on a card, then calculate the gap of the first and last time,it continues 3 menstrual cycles.Two needles will be inserted in each arm, one in each shoulder and one in each upper arm at nonacupuncture pointsAll the needles will be keep in positions for 30 min. Acupuncture will be performed three times per week,for a total of 36 sessions (12 wk).
Intervention Type
Other
Intervention Name(s)
acupuncture
Intervention Description
For RN4、CV6 CV3 and EX-CA1, needles will be inserted vertically to the abdominal muscles. The acupuncturist can feel resistance from the tip of the needle when touching the muscles and continues to insert it to a depth of 2-3 mm and stops. For ST36 and SP6, needles will be inserted vertically to a depth of 25 mm. The needles will be manipulated with an even lifting and twisting method three times to achieve the sensation of deqi.
Primary Outcome Measure Information:
Title
tubal patency rate
Time Frame
3 months
Secondary Outcome Measure Information:
Title
pregnancy rate
Time Frame
2 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
I.Patients between 22 and 42 years of age with infertility II.diagnosis of incomplete Fallopian tube obstruction based on one of the following conditions: a. Tubal patency test: Hydrotubation , Hysterosalpingography (HSG) or Hysterosonosalpingography (HSS) shows incomplete bilateral Fallopian tube obstruction b. Hysteroscopy: Hysteroscopic tubal cannulation hydrotubation proves bilateral tube incompletely patent. c. Laparoscopy: incomplete bilateral tubal obstruction can be displayed by the methylene blue solution through the tubes III.Other relative treatments are not carried out within two weeks IV.willing to cooperate with us V. mean infertility time is 1-5 years.
Exclusion Criteria:
I.allergic constitution or be allergic to diatrizoate or a variety of drugs II.the infertility is not leaded by tubal obstruction ,such as Congenital Physiological defects or malformation, genetic factors, immune factors and endocrine factors III.diagnosed with uterine lesions by auxiliary examinations (endometriosis ,adenomyosis , hysteromyoma or cancer and so on ) and infertility caused by tubal tuberculosis IV. infertility factor in their male partner V.people with Serious primary diseases of cardiovascular, liver, kidney and hematopoietic systems ,patients with mental illness VI.unable to judge the therapeutic efficacy or incomplete information VII.complete bilateral tubal obstruction VIII.bilateral tubes patent IX.Not willing to give written consent to the study X. people who are pregnant XI.people with acute infection .
Facility Information:
Facility Name
LiLiu
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
liu li, doctor
Phone
15045023666
Ext
+86
Email
liuliyouxiang2008@163.com
12. IPD Sharing Statement
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Effect of Acupuncture on Incomplete Fallopian Tube Obstructive Infertility: Study Protocol for Trial
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