Clinical trial NCT02867202: Adjuvant Therapy for Intrauterine Adhesions Between Two Groups
Official title: A Randomized Clinical Trial to Assess the Efficacy of Intrauterine Balloon Compared to Intrauterine Contraceptive Device Plus Foley Catheter in the Therapy for Uterine Adhesion After Hysteroscopic Adhesiolysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asherman Syndrome
Keywords: intrauterine balloon
Intrauterine Device Plus Foley Balloon Catheter
Asherman Syndrome
Lead sponsor: Wenzhou Medical University
Sponsor class: OTHER
First posted: 2016-08-15
Enrollment: 171
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was taken out to compare two mechanical devices (intrauterine balloon and Intrauterine Contraceptive Device Plus Foley Catheter) in the therapy for intrauterine adhesions after hysteroscopic adhesiolysis. Participates were assigned into two groups by randomly.

Detailed description: Intrauterine balloon and Intrauterine Contraceptive Device Plus Foley Catheter are both effective in the therapy for intrauterine adhesion.

The Intrauterine Contraceptive Device Plus Foley Catheter are usually inserted into the uterine after hysteroscopic adhesiolysis. Foley Catheter is removed after three days while intrauterine device is removed two or three month later.

The heart-shaped intrauterine balloon is designed to fit into the cavity of the uterus, and usually removed on the 7th day after surgery.

Eligibility criteria: Inclusion Criteria:

* Moderate to severe intrauterine adhesion (AFS score ≥5）
* Agreement to have a second-look hysteroscopy
* no previous history of hysteroscopic adhesiolysis

Exclusion Criteria:

* Minimal adhesion (AFS score\<5)
* Previous hysteroscopic adhesiolysis

Primary outcomes:
measure: the AFS Score at Second-look Hysteroscopy
timeFrame: 2 or 3 months after the surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: the 1st Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
Study officials:
affiliation: The 1st Affiliated Hospital of Wenzhou Medical University
name: Feng Lin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lin XN, Zhou F, Wei ML, Yang Y, Li Y, Li TC, Zhang SY. Randomized, controlled trial comparing the efficacy of intrauterine balloon and intrauterine contraceptive device in the prevention of adhesion reformation after hysteroscopic adhesiolysis. Fertil Steril. 2015 Jul;104(1):235-40. doi: 10.1016/j.fertnstert.2015.04.008. Epub 2015 Apr 30.
citation: Johary J, Xue M, Zhu X, Xu D, Velu PP. Efficacy of estrogen therapy in patients with intrauterine adhesions: systematic review. J Minim Invasive Gynecol. 2014 Jan-Feb;21(1):44-54. doi: 10.1016/j.jmig.2013.07.018. Epub 2013 Aug 9.
citation: Lin 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.