Coil Hysteroscopic Tubal Occlusion in the Treatment of Hydrosalpinx

NCT03395301 | Unknown DMC FDA Device

• 1 other identifier: Platinum coils
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hydrosalpinx

Keywords

hysteroscopy; fiber platinum coil; tubal occlusion

Outcome Measures

Primary Outcomes (1)

• Pregnancy rate

  Patients will be followed up with the pregnancy outcomes after the tubal occlusion

  2 months after IVF-ET

Study Arms (1)

tubal occlusion

EXPERIMENTAL

Fiber coils were inserted into the interstitial part of fallopian tubes, and IVF-ET was taken out in the following.

Device: Coil

Interventions

Coil DEVICE

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

tubal occlusion

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Have unilateral or bilateral hydrosalpinxs as evidenced by HSG.
• laparoscopic surgery was considered to be contraindicated because of ex-tensive pelvic adhesions.
• Are willing to undergo a hysterosalpingogram (HSG) 1 months after fiber platinum coil placement to confirm proximal tubal occlusion.
• Are willing to participate in this clinical study .Are able to comprehend and give informed consent for participation in this study.
• Have read, understood and signed an informed consent form .

You may not qualify if:

• 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
• Evidence of intrauterine abnormalities such as submucous fibroids, polyps, intrauterine adhesions or presence of a uterine septum
• Poor general or gynecologic health
• Inability or refusal to provide informed consent

Sponsors & Collaborators

• Wenzhou Medical University: lead

Study Sites (1)

the 1st Affiliated Hospital of Wenzhou Medical College

Wenzhou, Zhejiang, 325000, China

RECRUITING

Related Publications (2)

• 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.

  PMID: 23561020 BACKGROUND

• Wu YC, Huang XF, Yang HY, Chen X, Wang PY, Hu Y, Lin F. Fibered platinum coil: A novel option for the patients of hydrosalpinx with laparoscopic contradiction. Eur J Obstet Gynecol Reprod Biol. 2018 Oct;229:179-184. doi: 10.1016/j.ejogrb.2018.08.579. Epub 2018 Aug 27.

  PMID: 30205314 DERIVED

Study Officials

• Feng Lin, Gynecologist

  the 1st affiliated hospital of Wenzhou Medical College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Feng Lin, Gynecologist

CONTACT

13868585597; 234898067@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician

Model Details: Platinum coils were inserted into the tubes.

Study Record Dates

• First Submitted: May 19, 2016
• First Posted: January 10, 2018
• Study Start: December 1, 2015
• Primary Completion: June 30, 2018
• Study Completion: July 30, 2018
• Last Updated: January 10, 2018

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)