Condition category
Urological and Genital Diseases
Date applied
28/01/2013
Date assigned
15/02/2013
Last edited
06/05/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Asherman syndrome is a condition of uterine distortion resulting in amenorrhoea or hypomenorrhoea, infertility and recurrent pregnancy loss. The re-adhesion rate is high after surgical intervention. In our previous study, we compared the use of three different approaches to preventing recurrence of intrauterine adhesions following treatment of Asherman syndrome, namely, an intrauterine contraceptive device(IUD), a specially designed intrauterine balloon and hyaluronic acid gel, in addition to a control group. Both intrauterine balloon group and IUD group achieved significantly greater amount of reduction in the adhesion score than that of the hyaluronic acid gel group and control group. There was no significant difference in results between the balloon and IUD groups. The aim of this study is to compare the adhesion reformation prevention efficacy between balloon and IUD.

Who can participate?
Woman with confirmed uterine adhesion with moderate or severe degree by hysteroscopic examination and history review for the first time in Sir Run Run Shaw hospital is to be recruited. All the participants should be younger than 40 years old, having potential conceiving requirement.

What does the study involve?
The same hysteroscopic adhesion resection will be performed on all patients, and then they will be randomly allocated to two groups.
Group 1: fitting of an IUD (copper coil, Shandong contraceptive instrument company, China)
Group 2: fitting of a specially designed intrauterine balloon (Cook Company, UK)
Both devices will be removed in 1 week. In all cases hormone therapy is commenced from the day of operation, consisting of oestradiol valerate at a dose of 6 mg per day for 21 days with the addition of medroxyprogesterone acetate at a dose of 6 mg per day for the last 7 days of the oestrogen therapy. Following the withdrawal bleed, the hormone therapy was repeated for another cycle. A second look hysteroscopy was carried out in the early proliferative phase, 1-2 months after the initial operation.

What are the possible benefits and risks of participating?
The participants will receive comprehensive treatment for Asherman syndrome. For the intrauterine balloon is licensed for use for 24 hours, fitting in the uterine cavity for 7 days may increase the infectious risk. Other side effects are the complications related to the surgery.

Where is the study run from?
Reproductive medical center of Sir Run Run Shaw hospital, medical school, Zhejiang University, China

When is the study starting and how long is it expected to run for?
The study was started in April 2012 and will run 2 years or until 100 cases are recruited.

Who is funding the study?
Zhejiang Provincial Bureau of Health, China

Who is the main contact?
Dr Xiaona Lin
linna73@263.net, linxn@srrsh.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Xiaona Lin

ORCID ID

Contact details

Sir Run Run Shaw Hospital
3# Qingchun East Road
Hangzhou
310016
China
-
linxn@srrsh.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A comparison of intrauterine balloon stent and intrauterine contraceptive device in the prevention of adhesion reformation following hysteroscopic surgery for Asherman syndrome: a randomized case-control study

Acronym

Study hypothesis

Asherman syndrome is a condition of uterine distortion resulting in amenorrhoea or hypomenorrhoea, infertility and recurrent pregnancy loss. The re-adhesion rate is high after surgical intervention. The aim of this study is to compare the adhesion reformation prevention efficacy between balloon and IUD.

The principal questions of the research are the uterine adhesion reformation rate and following pregnancy rate after surgical resection of adhesion. We hypothesise the adhesion reformation rate is lower when the Cook balloon is inserted comparing to IUD, whereas the pregnancy rates are similar in two groups.

Ethics approval

Institutional review board of the Sir Run Run Shaw Hospital, Hangzhou, China, January 2013

Study design

Single center randomized case-control study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Asherman syndrome

Intervention

In all cases hysteroscopy is carried out under general anaesthesia which confirmed the presence of intrauterine adhesions. Hysteroscopy examination is carried out by two reproductive surgeons and the case is recruited if the AFS score is equal or more than 5. A 4.5 mm hysteroscope (Storz, Germany) is used in each case. The adhesions are divided with the use of hysteroscopic scissors. The procedures are carried out under ultrasound or laparoscopic guidance when necessary.

At the end of the procedure the patients were allocated to one of the two groups according to the randomized table:
1. Fitting of an IUD (copper coil, Yandai contraceptive instrument company, China)
2. Fitting of a specially designed intrauterine balloon (Cook medical company, Australia)

In all cases hormone therapy is commenced shortly after the operation, consisting of oestradiol valerate at a dose of 6 mg per day for 21-28 days with the addition of medroxyprogesterone acetate at a dose of 6 mg (check dose) per day for the last 7-10 days of the oestrogen therapy. All of the devices inserted will be removed in 7 days. Following the withdrawal bleed, the hormone therapy is repeated for another cycle.

A second look hysteroscopy is carried out in the early proliferative phase, 1-2 months after the initial operation, assessing the adhesion score by AFS criteria. Should recurrence of intra-uterine adhesions be confirmed during the second look hysteroscopy, a repeat adhesiolysis procedure would be performed.

Intervention type

Device

Phase

Drug names

Primary outcome measures

The severity and extent of intrauterine adhesions were scored according to a classification system recommended by the American Fertility Society (AFS) (1988 version). A score of 1-4 was considered to represent mild adhesions, a score of 5-8 was considered to represent moderate adhesions and a score of 9-12 as representing severe adhesions.

Secondary outcome measures

Pregnancy rates in both groups after surgery

Overall trial start date

01/02/2013

Overall trial end date

30/07/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Woman with confirmed uterine adhesion with moderate or severe degree [American Fertility Society (AFS score range 5~12)] by hysteroscopic examination and history review for the first time in Sir Run Run Shaw hospital is to be recruited.
2. All the participants should be >=18 years and younger than 40 years old, having potential conceiving requirement

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

200 cases. The enrollment will be stopped until 200 cases completed or the significant difference appears.

Participant exclusion criteria

1. Older than 40 years old
2. The AFS score less than 5
3. Who doesn't want to get pregnant
4. Who has received hysteroscopic adhesive resection before
5. Who can't follow up according to the study protocol

Recruitment start date

01/02/2013

Recruitment end date

30/07/2014

Locations

Countries of recruitment

China

Trial participating centre

Sir Run Run Shaw Hospital
Hangzhou
310016
China

Sponsor information

Organisation

Health Bureau of Zhejiang Province (China)

Sponsor details

216# CQingchun Road
Hangzhou
310002
China

Sponsor type

Government

Website

http://www.zjwst.gov.cn

Funders

Funder type

Government

Funder name

Zhejiang Health Science Foundation (China) (2011KYA084)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25936237

Publication citations

Additional files

Editorial Notes