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Comparing the Efficacy of Two Methods for the Therapy of Uterine Adhesion

Primary Purpose

Intrauterine Adhesion

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
dried biological amnion graft
disposable balloon uterine stent
estradiol valerate tablets
dydrogesterone Tablets
Sponsored by
Beijing Obstetrics and Gynecology Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Intrauterine Adhesion focused on measuring Asherman syndrome, uterine stent, hysteroscopy

Eligibility Criteria

20 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • age 20-45 years.
  • previously diagnostic hysteroscopy confirmed adhesion score ≧5, according to the American Fertility Society (AFS).
  • complains of menstruation disorder and reproductive dysfunction.
  • informed consent.

Exclusion Criteria:

  • premature menopause,
  • presence of other intrauterine lesions (e.g. polyps, myoma, septa), and
  • presence of severe intercurrent illness (e.g. systemic disease, coagulative disorders, severe kidney and liver diseases),
  • adhesions limited to the lower uterine cavity or the cervical canal.

Sites / Locations

  • Beijing Obstetrics and Gynecology Hospital, Capital Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

dried biological amnion graft

disposable balloon uterine stent only

Arm Description

dried biological amnion graft patients, who are with IUA, treated by uterine application of dried biological amnion graft + disposable balloon uterine stent + hormones (estradiol valerate tablets+dydrogesterone Tablets) following hysteroscopic adhesiolysis.

disposable balloon uterine stent patients, who are with IUA, treated by uterine application of disposable balloon uterine stent only + hormones (estradiol valerate tablets+dydrogesterone Tablets) following hysteroscopic adhesiolysis.

Outcomes

Primary Outcome Measures

second diagnostic hysteroscopy
American fertility society score ,Scores of 1-4, 5-8, and 9-12 were considered to represent mild, moderate, and severe adhesions, respectively

Secondary Outcome Measures

pregnancy
the number of biochemical pregnancy or clinical pregnancy
Menstruation Pattern
Amenorrhoea, hypomenorrhea, normal menstrual volume
adhesion reformation
Adhesion is seen under direct vision by hysteroscopy

Full Information

First Posted
October 20, 2017
Last Updated
November 14, 2017
Sponsor
Beijing Obstetrics and Gynecology Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03329898
Brief Title
Comparing the Efficacy of Two Methods for the Therapy of Uterine Adhesion
Official Title
Randomized, Controlled Trial to Assess the Efficacy of Disposable Balloon Uterine Stent Combined With Estrogen or Dried Biological Amnion Graft in the Prevention of Adhesion Reformation After Hysteroscopic Adhesiolysis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 31, 2017 (Actual)
Primary Completion Date
October 25, 2018 (Anticipated)
Study Completion Date
November 25, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Obstetrics and Gynecology Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Asherman's syndrome is characterized by the presence of intrauterine adhesions (IUA) as well as symptoms such as amenorrhea, hypomenorrhea, pelvic pain, and infertility. The gold standard for the treatment of intrauterine adhesions is hysteroscopic intrauterine adhesions. The recurrence of intrauterine adhesions is a major challenge in clinical practice. It has been reported that dried biological aminion graft was used to prevent adhesion after the operation of intrauterine adhesions. Intrauterine balloon can reduce the recurrence of adhesions after operation. Does the combination of balloon and amniotic products can improve clinical outcomes? Therefore, this study was conducted.
Detailed Description
The diaposable balloon uterine(a special intrauterine balloon) is usually inserted into the uterine after a hysteroscopic adhesiolysis and removed after on the 7th day after surgery. Another group, the diaposable balloon uterin and dried biological amnion will be inserted into the uterine after a hysteroscopic adhesiolysis and removed after on the 7th day after surgery.Several investigators demonstrated its favorable effect in the recurrence of adhesion after the treatment of intrauterine adhesion. Disposable balloon uterine stent is specially designed to fit into the cavity of the uterus, and usually removed on the 7th day after surgery. Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intrauterine Adhesion
Keywords
Asherman syndrome, uterine stent, hysteroscopy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
dried biological amnion graft
Arm Type
Experimental
Arm Description
dried biological amnion graft patients, who are with IUA, treated by uterine application of dried biological amnion graft + disposable balloon uterine stent + hormones (estradiol valerate tablets+dydrogesterone Tablets) following hysteroscopic adhesiolysis.
Arm Title
disposable balloon uterine stent only
Arm Type
Sham Comparator
Arm Description
disposable balloon uterine stent patients, who are with IUA, treated by uterine application of disposable balloon uterine stent only + hormones (estradiol valerate tablets+dydrogesterone Tablets) following hysteroscopic adhesiolysis.
Intervention Type
Procedure
Intervention Name(s)
dried biological amnion graft
Other Intervention Name(s)
uterine application of amnion membrance
Intervention Description
dried biological amnion graft. The amnion grafts were spread on the balloon end of disposable balloon uterine stent .
Intervention Type
Device
Intervention Name(s)
disposable balloon uterine stent
Intervention Description
the disposable balloon uterine stent 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.
Intervention Type
Drug
Intervention Name(s)
estradiol valerate tablets
Other Intervention Name(s)
Progynova
Intervention Description
oral estradiol valerate tablets, which can promote endometrial growth after operation.
Intervention Type
Drug
Intervention Name(s)
dydrogesterone Tablets
Other Intervention Name(s)
Duphaston
Intervention Description
oral dydrogesterone Tablets
Primary Outcome Measure Information:
Title
second diagnostic hysteroscopy
Description
American fertility society score ,Scores of 1-4, 5-8, and 9-12 were considered to represent mild, moderate, and severe adhesions, respectively
Time Frame
postoperation three months
Secondary Outcome Measure Information:
Title
pregnancy
Description
the number of biochemical pregnancy or clinical pregnancy
Time Frame
postoperation one year
Title
Menstruation Pattern
Description
Amenorrhoea, hypomenorrhea, normal menstrual volume
Time Frame
postoperation three months
Title
adhesion reformation
Description
Adhesion is seen under direct vision by hysteroscopy
Time Frame
postoperation three months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age 20-45 years. previously diagnostic hysteroscopy confirmed adhesion score ≧5, according to the American Fertility Society (AFS). complains of menstruation disorder and reproductive dysfunction. informed consent. Exclusion Criteria: premature menopause, presence of other intrauterine lesions (e.g. polyps, myoma, septa), and presence of severe intercurrent illness (e.g. systemic disease, coagulative disorders, severe kidney and liver diseases), adhesions limited to the lower uterine cavity or the cervical canal.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhu Ru, MD
Phone
13966636438
Email
zhuru19790202@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Wang Sha, PhD
Phone
15201556908
Email
wangsha1020@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Duan Hua, PhD
Organizational Affiliation
Beijing Obstetrics and Gynecology Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Beijing Obstetrics and Gynecology Hospital, Capital Medical University
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liu Zhen, MD
Phone
+8613718210767
Email
fcyykyb@163.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Comparing the Efficacy of Two Methods for the Therapy of Uterine Adhesion

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