Coil Hysteroscopic Tubal Occlusion in the Treatment of Hydrosalpinx

Hydrosalpinx Clinical Trial

Official title:

Coil Hysteroscopic Tubal Occlusion : the Treatment of Hydrosalpinx Before IVF-ET

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03395301
• Other study ID #: Platinum coils
• Status: Recruiting
• Phase: N/A
• First received: May 19, 2016
• Last updated: January 3, 2018
• Start date: December 1, 2015
• Est. completion date: July 30, 2018

Study information

• Verified date: December 2017
• Source: Wenzhou Medical University
• Contact: Feng Lin, Gynecologist
• Phone: 13868585597
• Email: 234898067[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

this study is to investigate the success rate of proximal tubal occlusion with coil devices in women with hydrosalinx and to observe there pregnancy rate with IVF-ET.

Description:

In this study, investigators will recruit 80 females with unilateral or bilateral hydrosalpinx as confirmed by HSG. Tubal ligation may be a safe and effective method in the treatment of hydrosalpinx. But in this study, investigators will use fiber platinum coils to occlude the tubes. After the treatment, IVF-ET will be applied,and then the patients' pregnancy rate will be assessed in the following-up.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: July 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Have unilateral or bilateral hydrosalpinxs as evidenced by HSG.

2. laparoscopic surgery was considered to be contraindicated because of ex-tensive pelvic adhesions.

3. Are willing to undergo a hysterosalpingogram (HSG) 1 months after fiber platinum coil placement to confirm proximal tubal occlusion.

4. Are willing to participate in this clinical study .Are able to comprehend and give informed consent for participation in this study.

5. Have read, understood and signed an informed consent form .

Exclusion Criteria:

1. Active or recent upper or lower pelvic infection

2. Known hypersensitivity to nickel as confirmed by skin test

3. Known allergy to contrast media Pregnancy or suspected pregnancy

4. Evidence of intrauterine abnormalities such as submucous fibroids, polyps, intrauterine adhesions or presence of a uterine septum

5. Poor general or gynecologic health

6. Inability or refusal to provide informed consent

Related Conditions & MeSH terms

• Hydrosalpinx

Intervention

Device:
• Coil
Fiber platinum coil were inserted into the interstitial part of the tubes of patients in hydrosalpinx through hysteroscopy

Locations

Country	Name	City	State
China	the 1st Affiliated Hospital of Wenzhou Medical College	Wenzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Wenzhou Medical University

Country where clinical trial is conducted

China, 

References & Publications (1)

Matorras R, Rabanal A, Prieto B, Diez S, Brouard I, Mendoza R, Exposito A. Hysteroscopic hydrosalpinx occlusion with Essure device in IVF patients when salpingectomy or laparoscopy is contraindicated. Eur J Obstet Gynecol Reprod Biol. 2013 Jul;169(1):54-9. doi: 10.1016/j.ejogrb.2013.02.008. Epub 2013 Apr 2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pregnancy rate	Patients will be followed up with the pregnancy outcomes after the tubal occlusion	2 months after IVF-ET