ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparing the Efficacy of Intrauterine Balloon and Intrauterine Contraceptive Device for the Therapy of Uterine Adhesion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02867202
Recruitment Status : Recruiting
First Posted : August 15, 2016
Last Update Posted : August 15, 2016
Sponsor:
Information provided by (Responsible Party):
Feng Lin, Wenzhou Medical University

Brief Summary:
This study was taken out to compare two mechanical devices (intrauterine balloon and intrauterine contraceptive device) in the therapy for intrauterine adhesions after hysteroscopic adhesiolysis. Participates were assigned into two groups by randomly.

Condition or disease Intervention/treatment Phase
Asherman Syndrome Device: Intrauterine balloon Device: Intrauterine contraceptive device Not Applicable

Detailed Description:

Intrauterine balloon and IUD are both effective in the therapy for intrauterine adhesion.

The IUD is usually inserted into the uterine after a hysteroscopic adhesiolysis and removed after two or three month later. Several investigators demonstrated its favorable effect in the recurrence of adhesion after the treatment of intrauterine adhesion.

The heart-shaped intrauterine balloon is specially designed to fit into the cavity of the uterus, and usually removed on the 7th day after surgery.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Clinical Trial to Assess the Efficacy of Intrauterine Balloon Compared to Intrauterine Contraceptive Device in the Therapy for Uterine Adhesion After Hysteroscopic Adhesiolysis
Study Start Date : June 2015
Estimated Primary Completion Date : February 2017
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adhesions

Arm Intervention/treatment
Experimental: Intrauterine balloon
The heart-shaped intrauterine balloon is designed to fit into the cavity of the uterus,and removed on the 7th day after surgery. And hysteroscopy was taken out again after two menstrual cycles to evaluate the uterine adhesions.
Device: Intrauterine balloon
After the completion of hysteroscopic adhesiolysis, intrauterine balloon was inserted and inflated with 3-5 mL normal saline which was removed after 1 week.
Other Name: COOK balloon

Experimental: Intrauterine contraceptive device
The IUD is inserted into the uterine after a hysteroscopic adhesiolysis and removed at the second hysteroscopy. Uterine adhesions were judged again at the second hysteroscopy.
Device: Intrauterine contraceptive device
After the completion of hysteroscopic adhesiolysis, copper IUD was inserted into the uterine cavity and removed after at the second time of hysteroscopy.
Other Name: IUD




Primary Outcome Measures :
  1. The change of AFS score (The American Fertility Society classifications)in two menstrual cycles [ Time Frame: baseline and two months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   19 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Moderate to severe intrauterine adhesion (AFS score ≥5)
  • Agreement to have second-look hysteroscopy
  • no previous history of hysteroscopic adhesiolysis

Exclusion Criteria:

  • Minimal adhesion (AFS score<5)
  • Previous hysteroscopic adhesiolysis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02867202


Contacts
Contact: Feng Lin, MD 0886-0577-88069525 linfeng983023@hotmail.com
Contact: Yuanqiu Wang, MD 0886-0577-88069525 1049250366@qq.com

Locations
China, Zhejiang
the 1st Affiliated Hospital of Wenzhou Medical University Recruiting
Wenzhou, Zhejiang, China, 325000
Contact: Feng Lin, MD    0886-0577-88069525    linfeng983023@hotmail.com   
Principal Investigator: Feng Lin, MD         
Sponsors and Collaborators
Wenzhou Medical University
Investigators
Principal Investigator: Feng Lin, MD the 1st Affiliated Hospital of Wenzhou Medical University

Publications:
Responsible Party: Feng Lin, attending doctor, Wenzhou Medical University
ClinicalTrials.gov Identifier: NCT02867202     History of Changes
Other Study ID Numbers: Wenzhou MC
First Posted: August 15, 2016    Key Record Dates
Last Update Posted: August 15, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Feng Lin, Wenzhou Medical University:
intrauterine balloon
intrauterine contraceptive device
Asherman Syndrome

Additional relevant MeSH terms:
Gynatresia
Genital Diseases, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs