Coil Hysteroscopic Tubal Occlusion in the Treatment of Hydrosalpinx

January 3, 2018 updated by: Feng Lin, Wenzhou Medical University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Feng Lin, Gynecologist
  • Phone Number: 13868585597
  • Email: 234898067@qq.com

Study Locations

  • China
    • Zhejiang
      • Wenzhou, Zhejiang, China, 325000
        • Recruiting
        • the 1st Affiliated Hospital of Wenzhou Medical College
        • Contact:
        • Principal Investigator:
          • Feng Lin, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Interventional Model: SEQUENTIAL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: tubal occlusion
Fiber coils were inserted into the interstitial part of fallopian tubes, and IVF-ET was taken out in the following.
Device: Coil
Fiber platinum coil were inserted into the interstitial part of the tubes of patients in hydrosalpinx through hysteroscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pregnancy rate
Time Frame: 2 months after IVF-ET
Patients will be followed up with the pregnancy outcomes after the tubal occlusion
2 months after IVF-ET

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wenzhou Medical University

Investigators

  • Principal Investigator: Feng Lin, Gynecologist, the 1st Affiliated Hospital of Wenzhou Medical College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2015

Primary Completion (ANTICIPATED)

June 30, 2018

Study Completion (ANTICIPATED)

July 30, 2018

Study Registration Dates

First Submitted

May 19, 2016

First Submitted That Met QC Criteria

January 3, 2018

First Posted (ACTUAL)

January 10, 2018

Study Record Updates

Last Update Posted (ACTUAL)

January 10, 2018

Last Update Submitted That Met QC Criteria

January 3, 2018

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Platinum coils

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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