Clinical trial NCT02320006: Effect of Acupuncture on Incomplete Fallopian Tube Obstructive Infertility: Study Protocol for Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Female Infertility Due to Occlusion of Fallopian Tube
Keywords: hydrotubation
incomplete fallopian tube obstructive infertility
Acupuncture
Lead sponsor: First Affiliated Hospital of Heilongjiang Chinese Medicine University
Sponsor class: OTHER
First posted: 2014-12-19
Enrollment: 120
Sex: FEMALE
Minimum age (years): 22
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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 .

Primary outcomes:
measure: tubal patency rate
timeFrame: 3 months
Secondary outcomes:
measure: pregnancy rate
timeFrame: 2 years
Other outcomes:
Locations:
city: Harbin
country: China
facility: LiLiu
state: Heilongjiang
Study officials:
References: