A comparison of Cook balloon and coil in the prevention of adhesion reformation following hysteroscopic surgery for Asherman syndrome
| ISRCTN | ISRCTN69690272 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN69690272 |
| Secondary identifying numbers | N/A |
- Submission date
- 28/01/2013
- Registration date
- 15/02/2013
- Last edited
- 06/05/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
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
Contact information
Scientific
Sir Run Run Shaw Hospital
3# Qingchun East Road
Hangzhou
310016
China
| linxn@srrsh.com |
Study information
| Study design | Single center randomized case-control study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study objectives | 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(s) | Institutional review board of the Sir Run Run Shaw Hospital, Hangzhou, China, January 2013 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | 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 study start date | 01/02/2013 |
| Completion date | 30/07/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 200 cases. The enrollment will be stopped until 200 cases completed or the significant difference appears. |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/02/2013 |
| Date of final enrolment | 30/07/2014 |
Locations
Countries of recruitment
- China
Study participating centre
310016
China
Sponsor information
Government
216# CQingchun Road
Hangzhou
310002
China
| Website | http://www.zjwst.gov.cn |
|---|
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2015 | Yes | No |
