NCT02708277

Brief Summary

The purpose of this study is to compare the outcome of loop intrauterine contraceptive device and heart-shaped intrauterine balloon for the adjunctive treatment of severe intrauterine adhesions in patients with infertility.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2011

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

March 4, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 15, 2016

Completed
2 months until next milestone

Results Posted

Study results publicly available

May 27, 2016

Completed
Last Updated

May 27, 2016

Status Verified

April 1, 2016

Enrollment Period

4.2 years

First QC Date

March 4, 2016

Results QC Date

March 22, 2016

Last Update Submit

April 21, 2016

Conditions

Asherman's Syndrome

Keywords

intrauterine contraceptive deviceintrauterine balloon

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Pregnancy in Loop-shaped Intrauterine Device Group and Intrauterine Balloon Group

    three years

Secondary Outcomes (3)

  • Menstruation Pattern(Improvement or No Significant Change) of All Participants

    Within the first 3 months after surgery

  • Endometrial Thickness of All Participants in the Mid Menstrual Measured by Color Doppler Ultrasound

    Within the first 3 months after surgery

  • Number of Participants With Reformation of Intrauterine Adhesions in Loop-shaped Intrauterine Device Group and Intrauterine Balloon Group

    Within the first 3 months after surgery

Study Arms (2)

Group A

EXPERIMENTAL

At the end of the procedure the surgery loop-shaped intrauterine contraceptive device (IUCD) was placed in the uterine cavity.

Device: loop-shaped intrauterine contraceptive device

Group B

EXPERIMENTAL

At the end of the procedure the surgery an intrauterine balloon (Cook Medical) was placed in the uterine cavity.

Device: intrauterine balloon (Cook Medical)

Interventions

loop-shaped intrauterine contraceptive deviceDEVICE

Intrauterine contraceptive device can temporary protective layer between the endometrium wound during the most critical three weeks after the surgery to prevent adhesion reformation.

Group A
intrauterine balloon (Cook Medical)DEVICE

The balloons used in this study is heart- shaped that resembled the shape of the uterine cavity and could fully separate the two sides of the uterine wall and the corners of the uterus compare to loop-shaped intrauterine contraceptive device.

Group B

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of severe intrauterine adhesions
  • infertility

You may not qualify if:

  • endometrial tuberculosis
  • grossly abnormal semen analysis
  • ovarian failure, hydrosalpinx fluid
  • patients who did not proceed to second-look hysteroscopy within the specified time frame
  • Women with no desire to pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Orhue AA, Aziken ME, Igbefoh JO. A comparison of two adjunctive treatments for intrauterine adhesions following lysis. Int J Gynaecol Obstet. 2003 Jul;82(1):49-56. doi: 10.1016/s0020-7292(03)00030-4.

    PMID: 12834941RESULT

MeSH Terms

Conditions

Gynatresia

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Limitations and Caveats

This study was conducted in a university hospital.If this was a multicenter study, the results should be more reasonable.

Results Point of Contact

Title
Yuqing Chen
Organization
The First Affiliated Hospital of Sun Yat-sen University
fangchenyq@163.com
+86 020-87755766-8341

Study Officials

  • Shuzhong Yao, professor

    First Affiliated Hospital, Sun Yat-Sen University

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate chief physician

Study Record Dates

First Submitted

March 4, 2016

First Posted

March 15, 2016

Study Start

January 1, 2011

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

May 27, 2016

Results First Posted

May 27, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will share