Coil Hysteroscopic Tubal Occlusion : the Treatment of Hydrosalpinx Before IVF-ET
Phase: NA
Conditions: Hydrosalpinx
Sponsor: Wenzhou Medical University

Cover Page 
Official title of the study: Coil Hysteroscopic Tubal Occlusion, 
the Treatment of Hydrosalpinx Before IVF-ET 
Date: 12/01/2015 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Study protocol 
The problem to be investigated 
Project title: Coil Hysteroscopic Tubal Occlusion, the Treatment 
of Hydrosalpinx Before IVF-ET 
Research problem: This will be an investigation to evaluate the 
success rate of proximal tubal occlusion with coil devices in 
women with hydrosalpinx and to observe the pregnancy rate 
with IVF-ET.  
Background: Many studies have proposed that hydrosalpinx 
fluid may decrease the pregnancy rate following IVF-ET 
(Zeyneloglu HB, 1998; Strandell A, 1999; Nackley AC, 1998). 
During nearly two decades, researchers have find many 
treatments to improve the outcomes of IVF-ET with 
hydrosalpinx, such as fluid extraction, salpingectomy, proximal 
tubal occlusion with Essure device (HTO-E) and other devices 
(D'Arpe S, 2015; Lorente Gonzalez J, 2016;). However, 
extraction cannot prevent the refluxing of fluid which may 
directly poison the embryos while salpingectomy may decrease 
the ovarian response. Laparoscopic salpingectomy may increase 
the risk for patients who have had a history of severe pelvic 
adhesions. Besides, proximal tubal occlusion with Essure have 
been demonstrated to be companied by some severe 

complications (Walter JR, 2017). Therefore, another safer device 
should be investigated. Fibered platinum coils have been used in 
aneurysm and endovascular therapy more than a decade ago 
(Tsai CW, 1996). However, with wide usage, the complication 
was few (Syha R, 2016).  
The aims: The aim of our study was to evaluate the successful 
and complication rate after occlusion with fibered platinum coils, 
and to observe the pregnancy rate following IVF-ET.  
(v)    The hypothesis: Hysteroscopic occlusion will be an 
alternative to the treatment of hydrosalpinx before IVF-ET. 
2. Methods of investigation: 
Subjects: 80 females between 20-45 years old with unilateral or 
bilateral hydrosalpinx as confirmed by HSG.  
Inclusion criteria:  
1. Have unilateral or bilateral hydrosalpinx as evidenced by 
HSG. 
2. Laparoscopic surgery was considered to be contraindicated 
because of suspected extensive pelvic adhesions. 
3. Patients are willing to undergo a hysterosalpingogram (HSG) 
3 months after tubal occlusion. 
4. Patients are willing to participate in this clinical study. 
5. Patients are able to comprehend and give informed consent 

for participation in this study. 
6. Have read, understood and signed an informed consent form. 
Exclusion Criteria: 
Active or recent upper or lower pelvic infection 
Known hypersensitivity to nickel as confirmed by skin test 
Known allergy to contrast media pregnancy or suspected 
pregnancy 
Poor general or gynecologic health 
Inability or refusal to provide informed consent 
Design: subjects who meet the inclusion and exclusion criteria 
will be eligible, all the eligible subjects will be interviewed and 
the purpose of the trial will be outlined. Epidemiologic data will 
also be collected. 
Experimental procedure: hysteroscopic tubal occlusion will be 
performed in the 3-7days after the menses. In the third day after 
the surgery, a vaginal ultrasound will be performed to confirm 
the position of coil. 3 months later, HSG will be taken out to 
confirm the occlusion of tubes. After the treatment, IVF-ET will 
be applied and then the patients' pregnancy rate will be assessed 
in the following-up.