Intrauterine Balloon and Postoperative Estrogen Therapy in the Prevention of Adhesion Reformation After Hysteroscopic Adhesiolysis
Randomized, Controlled Trial Comparing the Efficacy of Intrauterine Balloon and Postoperative Estrogen Therapy in the Prevention of Adhesion Reformation After Hysteroscopic Adhesiolysis
1 other identifier
interventional
310
0 countries
N/A
Brief Summary
Patients who want to go TCRS will randomly divided 3 groups. In Group 1(100 patients), women received postoperative estrogen therapy. In Group 2 (100 patients), a Foley catheter with the balloon inflated with 4 ml of normal saline solution will be placed into the uterine cavity at the end of the operation for five days. In Group 3 (110 patients), women will not receive any of the treatment (comparison group). All subjects underwent two further hysteroscopy, one and three months after the initial surgery. At the second or third look hysteroscopy, the incidence of intra-uterine adhesion will be analyzed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2019
Typical duration for not_applicable
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
First Submitted
Initial submission to the registry
November 23, 2015
CompletedFirst Posted
Study publicly available on registry
November 30, 2015
CompletedStudy Start
First participant enrolled
December 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2021
CompletedOctober 2, 2019
September 1, 2019
1.9 years
November 23, 2015
September 30, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
A comparison of the presence and severity(American Fertility Society score) of intra-uterine adhesions at second look and third look hysteroscopy
the incidence and severity of adhesions (as measured according to the American Fertility Society scoring system) between the groups
1 year
Study Arms (3)
Foley balloon
EXPERIMENTALFoley balloon following TCRS: a Foley balloon with 4 ml of normal saline solution will be placed into the uterine cavity at the end of the operation for five days.
control groups
NO INTERVENTIONcontrol groups: women will not receive any therapy of the treatment (comparison group).
postoperative estrogen therapy groups
EXPERIMENTALSubjects received postoperative hormone therapy as per the protocol in use in our center for Asherman Syndrome. Immediately after the operation, the subjects were started on a 3- month course of cyclical hormonal therapy, consisting of orally administrated oestradiol valerate 2-4mg/day for 21 days, orally administrated medroxyprogesterone acetate 8mg /day from day 12 to 21 of the oestradiol valerate therapy. The second treatment cycle started one week after the completion of the first cycle, and the third treatment cycle started one week after the second cycle.
Interventions
a Foley balloon with 4 ml of normal saline solution will be placed into the uterine cavity at the end of the operation for five days.
Eligibility Criteria
You may qualify if:
- Patients who will go hysteroscopic transection of uterine septum between 2016 to 2017 at the Hysteroscopy Center, Fuxing Hospital;
- Patients willing to undergo followed hysteroscopy about 4 and 12 weeks after the surgery to assess the reformation of intrauterine adhesions;
- Written informed consent obtained.
You may not qualify if:
- ongoing pregnancy;
- Peroperative fever or infections;
- Malignancy;
- Precious pelvic inflammatory disease;
- Uterine fibroid (\>3cm size);
- endometriosis;
- Contraindications for anesthesia;
- Not able to read and/or understand informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (4)
Hassan MA, Lavery SA, Trew GH. Congenital uterine anomalies and their impact on fertility. Womens Health (Lond). 2010 May;6(3):443-61. doi: 10.2217/whe.10.19.
PMID: 20426609BACKGROUNDBrucker SY, Rall K, Campo R, Oppelt P, Isaacson K. Treatment of congenital malformations. Semin Reprod Med. 2011 Mar;29(2):101-12. doi: 10.1055/s-0031-1272472. Epub 2011 Mar 24.
PMID: 21437824BACKGROUNDLin X, Wei M, Li TC, Huang Q, Huang D, Zhou F, Zhang S. A comparison of intrauterine balloon, intrauterine contraceptive device and hyaluronic acid gel in the prevention of adhesion reformation following hysteroscopic surgery for Asherman syndrome: a cohort study. Eur J Obstet Gynecol Reprod Biol. 2013 Oct;170(2):512-6. doi: 10.1016/j.ejogrb.2013.07.018. Epub 2013 Aug 7.
PMID: 23932377BACKGROUNDConforti A, Alviggi C, Mollo A, De Placido G, Magos A. The management of Asherman syndrome: a review of literature. Reprod Biol Endocrinol. 2013 Dec 27;11:118. doi: 10.1186/1477-7827-11-118.
PMID: 24373209BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Tinchiu Li, Ph.D.
Chinese University of Hong Kong
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr.
Study Record Dates
First Submitted
November 23, 2015
First Posted
November 30, 2015
Study Start
December 1, 2019
Primary Completion
November 1, 2021
Study Completion
November 1, 2021
Last Updated
October 2, 2019
Record last verified: 2019-09