| BACKGROUNDIt is estimated that30-35%of infertility is caused by the tubal factor. Thus, the evaluation of tubal patency is a very important part of infertility work up. Tubal infertility can result from salpingitis, peritubal infection, endometriosis, past abdominal or pelvic surgery, tumor compression and congenital abnormal development. Currently, we judge the degree of tubal damage by the extent of tubal patency and peritubal synechia.In the past time, there were three ways widely used in clinic, including hydrotubation, hysterosalpingography (HSG) and laparoscopy chromopertubation (LC). However, as it is a subjective method, but also has low accuracy, hydrotubation has gradually fallen to disuse as a diagnostic method. Though HSG is still widely used, it is not accepted by all infertile patients for the risk of x-ray irradiation and ionizing radiation. Besides, it can’t provide information on ovaries, uterus and pelvic disease and so on. What’s worse, it may over diagnose tubal occlusion possibly due to tubal instant spasm. Today, LC is still the gold standard for assessing tubal disease. However, it requires general anesthesia and hospital stay, thus cost quite much. What’s worse, it has the risk of intestinal perforation, hemorrhoea and so on. A recent report of community-based questionnaire survey said that LC was the least preferred method for assessing tubal patency, for postoperative scare and required general anesthesia. Therefore, a method of more simple, minimal invasive, objective and cheap to assess tubal patency is still the focus of attention in the reproductive area.In recent years, as the development of contrast medium, contrast-enhanced ultrasound has developed fast. TV HyCoSy was introduced by the experts to assess tubal patency. The method was injecting contrast medium through the catheter into the uterine cavity, and observing the course of the fallopian tubes, supplemented by the contrast medium diffusion in the pelvis to judge tubal patency. It is a method of simple, cost effective and short procedure. Thus, it is more acceptable to infertility. Moreover, compared with HSG, it has been found that women better tolerate HyCoSy [0-12]Gradually, HyCoSy has developed from using negative contrast agent (saline solution) to positive contrast agent (microbubble contrast agent). The imaging mode developed as the improvement of technique, which developed from two-dimensional imaging to three-dimensional imaging. In a recent review, Rhiana et al reported rates of78.1%to90.9%for concordance in HyCoSy with LC. The diagnostic accuracy of3D-HyCoSy even reached90%. However, three-dimensional imaging was incontinous captured, and lack of real-time, dynamic, continous. Thus, it was difficult to obtain a satisfied image to the circuitous fallopian tube. Real-time three-dimensional ultrasound, which was also named four-dimensional ultrasound, has overcome the shortcoming of incontinous of three-dimensional imaging, and obtained more information. Currently, it is widely applicated in the aspect of fetal imaging.There is rare reported on the combination of contrast-enhanced ultrasound and four dimension ultrasound to assess fallopian tubal patency, and we will try and explore combination in this aspect in this study. The imaging feature, observation index, and judging standerd of tubal patency in TV4D-HyCoSy with SonoVue will be studied, which will also be compared with LC, and evaluated its clinical value.Chapter One TV4D-HyCoSy assessing fallopian tubal patencyOBJECTIVEThe objective of this chapter is to study feasibility of TV4D-HyCoSy in assessing tubal patency, sonographic evaluation standard and evaluation method.METHODS1DesignThis was a prospective cohort research.2PatientsThis study was carried out in a university hospital between July2011and December2012.173outpatients visiting infertility clinics were included in the study.67were primary infertile, and the rest were secondary infertile. All the patients signed the informed consent.3Examination timeThe HyCoSy procedure was performed between days3to7after the last menstrual period. Vaginal secretion was examined before HyCoSy to exclude vaginitis.4Ultrasound equipment (1) Equipment:Voluson E8Expert (GE Medical Systems Zipf, Austria).(2) Probe:RIC5-9-D volume probe (5-9MHz).(3) Equipment setting for Contrast2D:Mechanical Index (0.14, adjust according to the power output), Mode (Coded Pulse Inversion or Color code imaging simultaneous), Angle (179°), Sensitivity/Pulse Repetition Interval (1.5). Equipment setting for Contrast3D:Volume Box Angle (179°)/Volume Angle (120°), Quality (Mid1).(4) Equipment setting for Contrast4D:Volume Box Angle (179°)/Volume Angle (120°), Quality (Low), Direction (Up/Down), Render mode (gradient light), Threshold Low (<20, adjust according to the image), Frame Rate (0.6).5Confecting spasmolytic and contrast medium(1) Spasmolytic is a mixture solution of80000u gentamycin,50mg lidocaine,0.25mg atropine,2.5mg dexamethasone and10ml of0.9%sterile saline solution.(2) The contrast medium was prepared by adding5ml of0.9%sterile saline solution to59mg of SonoVue freeze-dried powder. Then we aspired2ml of the SonoVue solution and diluted into20ml suspension with0.9%sterile saline solution.6Conventional ultrasound, disinfection and intubation(1) All patients were initially examined by transvaginal ultrasonography to evaluate uterus, ovaries, adnexa, and measured the initial absence of fluid in the pouch of Douglas. Observe the relative position of ovaries to the uterus in the the transverse section and push the ovaries with the probe as a method of deep palpation to observe the ovarian mobility in our unit.(2) We assigned an ovarian mobility score ranging from1to3as follows.I:moved obviously opposite to uterus;II:moved slightly opposite to uterus;III:not moved at all. (3) The cervix was disinfected and a Foley catheter was inserted into the uterine cavity under direct visualization.(4) Take the conventional transvaginal ultrasonography again.74D-HyCoSy(1) ProcedureThe transvaginal volume probe was positioned to visualize the transverse section of bilateral uterus horns. Then we started the3D-ultrasound scan mode for prescan and adjusted the position of the probe to ensure scanning bilateral uterine horns and ovaries to find out the initial plane. When the initial plane was determined, the probe could not be moved. We then converted to4D-contrast mode, adjusted the volume angle, and maximized the region of interest. The nurse injected SonoVue into the uterus. As long as we saw the spray of fimbral end of the tubes of bilateral or the objective one, we could stop injecting SonoVue and saved the dynamic image. Then, observe the two-dimensional development of bilateral fallopian tube through A plane by three-dimensional imaging. Last, we observed diffusion of the contrast agent around the ovary and in the pelvis in code imaging simultaneous.(2) The periovarian diffusion was classified to four ranks.Rank ⅰ:ring-like periovarian diffusion (contrast agent encircling more than2/3of the brim of the ovarian).Rank ⅱ:half ring-like periovarian diffusion (contrast agent encircling2/3-1/2of the brim of the ovarian).Rank ⅲ:less than half ring-like periovarian diffusion (contrast agent encircling less than1/2of the brim of the ovarian).Rank ⅳ:no periovarian diffusion.(3) Type of tubal patency of4D-HyCoSyWe described the extent of tubal patency as three types:type A, B and C. In the image of type A, the tube was patent and the contrast medium flowed fluidly through it. The contrast agent filled the uterine cavity, and flowed to the uterine horn, through the fallopian tube, finally sprayed at the fimbral end of the tube. Besides, the passage of the tube was soft and naturally downwards.In the image of type B, the tube was patent, but the contrast agent didn’t flow fluidly inside it. We also saw that the entire fallopian tube and the spray or spill of the fimbral end of the tube. Yet, the fallopian tube developed intermittently and the passage of the tube was narrow, stiff, angled, circuitous or upwards.In the image of type C, the tube was blocked. We can’t see the entire passage of fallopian tube or the spray of the fimbral end of the tube.8Pain scoreDuring the exam, we also assigned a pain score as follows:0:no reaction or discomfort;1:slight pain, less than or the same as menstrual pain;2:moderate pain, exceeding menstrual cramps but no vasovagal reaction;3:slight vasovagal reaction and need’t observation in a hospital;4:severe vasovagal reaction or pain requiring observation in a hospital;5:vasovagal reaction or pain requiring resuscitation.9Follow-up visitOne week after4D-HyCoSy, the telephone call was made to every patient to inquire the post-procedure discomfort. All the patients will receive phone follow-up about the follow-up care and pregnancy every3months until successful pregnancy.10Statistical analysisAll statistical analysis was performed using SPSS for windows version13.0(SPSS Inc., Chicago, IL, USA). Data were expressed as means±standard deviations or percentages. Kruskal-Wallis Test was adopted for the multiple-groups’ comparison of categorical data and Mann-Whitney U test was adopted for the two groups’ comparison of categorical data, while Chi-Square test was adopted for constituent ratio for two groups’ comparison or population rate for multiple groups’ comparison was adopted. The correlation of the data was analyzed by way of Spearman rank correlation. A P value of<0.05was considered significant.RESULTS1Successful examination173patients accepted4D-HyCoSy. Among them, the fallopian tubes of2patients (both were secondary infertility) were disturbed by intravasation and the intravasation occurred earlier than tubal development. In result, the fallopian tubes could not be recognized and diagnosed.2The pain scores during4D-HyCoSy0:2.9%(5/173);1:31.8%(55/173);2:49.1%(85/173);3:9.8%(17/173);4:6.4%(11/173);5:0.0.3The usual post-procudure discomfort and duration7patients were lost to follow-up (no answer to the mobile phone). The main post-procudure discomfort was hypogastralgia and a small amount of vaginal bleeding (Chart1-1). The hypogastralgia discomfort disappeared in24hours in90.4%patients and vaginal bleeding disappeared in3days in92.2%patients 4Examination timeThe whole time of sonography (including conventional assessing pelvic condition, intubation, contrast-enhanced sonography till completing the report) was24.3±9.7minutes, and the time for merely contrast-enhanced sonography (4D-HyCoSy,3D-HyCoSy and observing peritubal difusssion and pelvic diffusion)was8.8±5.4minutes on average.5Tubal patency distributionThe type of tubal patency of both primary and secondary infertility was mainly bilateral type A. The distribution of tubal patency between the primary and secondary infertility was significant different, P<0.05. The proportion of at least unilateral type A or type B fallopian tubes in the primary infertility was much higher than that in the secondary infertility (Chart1-2). There was significant difference between those who with the uterine cavity operation (including secondary infertility, hydrotubation history and HSG history) and those without uterine cavity operation in the tubal patency distribution, P<0.05(Chart1-3). The proportion of unilateral and bilateral tubes was higher in those without uterine cavity operation. 6The relationship between ipsilateral ovarian mobility or ipsilateral periovarian diffusion and tubal patency In the171infertile patients, the ipsilateral ovarian mobility in the fallopian tube of type A was significant better than that of type B or C, P<0.0125(Chart1-4). The ipsilateral ovarian mobility was positively correlated to the tubal patency(P=0.000, r=0.299).The ipsilateral periovarian diffusion rang from more to less:ipsilateral periovarian diffusion of type A, ipsilateral periovarian diffusion of type B, ipsilateral periovarian diffusion of type C. There was significant difference among the three groups, P<0.05. The comparison between ipsilateral periovarian diffusion of type A and type B, between ipsilateral periovarian diffusion of type A and type C, or between ipsilateral periovarian diffusion of type B and type C had significant difference, P<0.0125. Ipsilateral periovarian diffusion (P=0.000, r=0.610)(Chart1-5) was positively correlated with the tubal patency in171subject.Therefore, the better the ipsilateral ovarian mobility and the more ipsilateral periovarian diffusion, suggested the better of the tubal patency. 7Tubal patency distribution of the infertility by4D-HyCoSy and its relationship with intravasationAmong the171infertility that finished HyCoSy successfully and obtained successful images, intravasation occurred in36patients. They were classified into3groups according to the tubal patency (Chart1-6). The incidence of intravasation ranged from high to low in group c, group a and group b. And there was significant difference among the three group (P=0.018). There was no significant difference between group a and group b (P=0.746). Either the incidence of group a (P=0.008) or group b (P=0.009) was significantly lower than that of group c. Therefore, the incidence of intravasation in the patients with bilateral type C fallopian tubes was significantly higher than that of at least one tube of type A or type B. In addition, the incidence of intravasation in the secondary infertility (30/106) was significantly higher than that in the primary infertility (8/67)(P=0.012; AR secondary infertility=92.48; AR primary infertility=78.33). 8Follow-up visit7patients were lost to follow-up (no answer to the mobile phone). The patients usually appeared hypogastralgia and a small amount of vaginal bleeding.50.9%(88/173) accepted surgery and monitored ovulation or merely monitored ovulation.12.7%(22/173) successfully have got pregnant,7of which got pregnant without sugery and5of which have been under controlled ovarian hyperstimulation treatment after LC.CONCLUSIONS1All of patients successfully finished the TV4D-HyCoSy, and most of the patients got the diagnostic reports. Few patients could not judge the tubal patency because of uterine intravasation, which occurred earlier than bilateral tual development, and influenced the tubal imaging. That is to say, the successful rate reached100%, and the satisfied image obtaining rate with TV4D-HyCoSy reached99%. Therefore, this method was feasible.2All of the patients could tolerate this examination. Most of them appeared lower abdominal pain during HyCoSy. The major postprocedure discomforts were small amount of vaginal bleeding and lower abdominal pain,90%of which disappeared in3days. 3TV4D-HyCoSy is a method of time-saving. Compared with traditional HSG, this method reduced the patients’ waiting time and back to hospital frequency. Moreover, they can get the diagnostic report in a short time.4Most of the infertility had bilateral type A fallopian tubes. The proportion of unilateral and bilateral type C fallopian tubes was higher in patients of secondary infertility or those who had uterine cavity operation history. Thus, the secondary infertile patients or those who had uterine cavity operation history should concern more to tubal patency examination.5The ovarian mobility and periovarian disffusion was positive related to the ipsilateral fallopian tube. If the ovarian mobility was better and the more diffussion around the ovary, the tubal patency was better. So, the ovarian mobility and periovarian diffusion may be helpful in assessing tubal patency.6Injecting spasmolytic or contrast medium into the uterus with bilateral blocked fallopian tubes, the uterine cavity pressure increased obviously and resulted in intravasation. And because of the proportion of type C fallopian tubes was higher and the probability of intravasation increased.Chapter Two Comparison between TV4D-HyCoSy and LC in assessing fallopian tubal patencyOBJECTIVEThe objective of this chapter is to explore the clinical value of TV4D-HyCoSy in assessing tubal patency by comparing with LC.METHODS1Design This was a prospective cohort research.2PatientsAmong the above171outpatients who successfully finished HyCoSy and got the tubal patency results,20patients accepted LC on their own intention. Totally,40fallopian tubes were assessed.3Examination time and contraindicationsThe same as Chapter One.4LC equipment and settingsTelevision laparoscopic system:Olympus television laparoscopic system, which were composed of optical system, inflation system, suction system, electrosurgery instrument system, rotatory-cut equipments and LC dedicated instruments.5TV4D-HyCoSyThe same as Chapter One.6Tubal patency in TV4D-HyCoSyWe classified the tubal patency to Type A, Type B, Type C as Chapter One. To compare the results with LC, we classified Type A and Type B as the not obstructed fallopian tube, while the Type C as the obstructed fallopian tube.7Observing the spray at the frimbrea end of the fallopian tubes and ranking themGrade0:there was spray at the frimbrea at of the fallopian tube;Grade1:there was spill at the frimbrea at of the fallopian tube, but the spray was not obvious;Grade2:there was no spill at the frimbrea at of the fallopian tube.8LCThe assistant inject10-20ml dye into the uterine cavity to judge the patency of the fallopian tubes and the blocked place. 9Tubal patency of LCPatent:There was no adhesion around the fallopian tube. When injecting6-10ml dye, the fallopian tube enlarged evenly without partial enlargement. And the dye spill out of the frimbral end of the fallopian tube.Not fully blocked:There was adhesion around the fallopian tube, which partially wrapped the frimbral end of the fallopian tube. There was resistance when injecting dye and the fallopian tube enlarged obviously. After pressure injection15-20ml dye, there was a small amount of dye spilling.Fully blocked:There might has or hasn’t adhesion around the fallopian tube of distal obstruction. No tubal aperture could be found or the frimbral end of the fallopian tube was wrapped closely. There was a strong resistance when injecting dye. No spill of the frimbral end of the fallopian tube even after pressure injection. The fallopian tube enlarged obviously and the frimbral end of the fallopian tube enlarged like a blind pocket. However, the fallopian tube of proximal obstruction did not enlarge when injecting dye.To compare the result with sonography, the patent and not fully blocked tubes were classified as the not obstructed fallopian tubes, and the fully blocked tubes were obstructed ones.10Assessing peritubal adhesionAssess peritubal adhesion by observe whether there was adhesion around the fallopian tube.11Follow-up visitAll the patients will receive phone follow-up about the follow-up care and pregnancy every3months until successful pregnancy.12Statistical analysis All statistical analysis was performed using SPSS for windows version13.0(SPSS Inc., Chicago, IL, USA). Data were expressed as means±standard deviations or percentages. Mann-Whitney U test was adopted for the two groups’ comparison of categorical data. The correlation of the data was analyzed by way of Spearman rank correlation. Pearson Chi-Square was adopted for comparison of two independent-sample rates. A P value of<0.05was considered significant.RESULTS1The diagnostic sensitivity of TV4D-HyCoSy to the three type of fallopian tubesThe tubal patency of TV4D-HyCoSy was compared to LC (Chart2-1).16fallopian tubes were proved patent,9not fully blocked and15fully blocked. The detection rates of these three types of fallopian tubes were37.5%(6/16),89%(8/9), and93%(14/15) with4D-HyCoSy. The detection rate of patent fallopian tube was minimum,50%(8/16) of which were misdiagnosed as not fully blocked and12.5%(2/16) of which were misdiagnosed as fully blocked.2The diagnostic accuracy of TV4D-HyCoSy to the three type of fallopian tubesComparison of the results (Chart2-1) between LC and4D-HyCoSy in20infertile patients (7primary infertility and13secondary infertility) who accepted LC.HyCoSy suggested6fallopian tubes of Type A, which were confirmed patent by LC;17fallopian tubes of Type B,8of which were confirmed the same as HyCoSy in LC;17fallopian tubes of,14of which were confirmed blocked in LC. Therefore, the accuracy of judging fallopian tubes of Type A, Type B, Type C was100%,47%,82%respectively. 3The diagnostic value of TV4D-HyCoSy to obstructed fallopian tubesWe classified Type A and Type B fallopian tubes in4D-HyCoSy or patent and not fully blocked fallopian tubes in LC as not obstructed fallopian tubes, while Type C fallopian tubes in4D-HyCoSy or fully blocked fallopian tubes in LC as obstructed tubes. Take LC as gold standard, the sensitivity, specifity, positive predictive value, negative predictive value and Youden’s index of4D-HyCoSy were93%,88%,82%,96%, and0.81respectively. There was no significant difference between LC and TV4D-HyCoSy on assessing tubal patency (χ2=0.648). That is to say, TV4D-HyCoSy was as good as LC in assessing tubal patency.4The value of spray at the frimbrea end of the fallopian tube to judging peritubal adhesion in LCThere was no significant difference between adhesion tubes and no adhesion tubes on the ovarian mobility (P=0.104) in the20patients who accepted surgery(Chart2-3). The periovarian diffusion score in the no peritubal adhesion group significantly lower than that in the peritubal adhesion group.5Ovarian mobility and periovarian diffusion between the group with and without peritubal adhesion confirmed in LCBy observing the spray of the frimbral end of the fallopian tubes in4D-HyCoSy, we judged peritubal adhesion.In the40fallopian tubes with operation control, the area under ROC curve for spray of the frimbral end of the fallopian tube judging peritubal adhesion was0.746, and the standard error was0.079. The spray of the frimbral end of the fallopian tube judging peritubal adhesion was of great significant (P=0.008;95%CI (0.591,0.901)).(Chart2-4) CONCLUSIONS1The diagnostic sensitivity of TV4D-HyCoSy to type A was low, wihle the accuracy was high. On the contrary, the diagnostic sensitivity of TV4D-HyCoSy to type B was high, wihle the accuracy was low. However, both the sensitivity and accuracy of4D-HyCoSy to type C was high. Therefore, it is very important to differentiate fallopian tubes of Type A and Type B in TV4D-HyCoSy.2The sensitivity, specifity, positive predictive value, negative predictive value and Youden’s index were high, which could assess tubal patency well and truly. TV4D-HyCoSy was as good as LC in assessing tubal patency.3By observing spray at the frimbrea end of the fallopian tube and periovarian diffusion, we could judge whether there was peritubal adhesion. The more obvious of the spray at the frimbrea end of the fallopian tubes, and the better the periovarian diffusion, the lower possibility of peritubal adhesion. |
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