Comparing the Efficacy of Intrauterine Balloon and Intrauterine Contraceptive Device for the Therapy of Uterine Adhesion
|ClinicalTrials.gov Identifier: NCT02867202|
Recruitment Status : Unknown
Verified August 2016 by Feng Lin, Wenzhou Medical University.
Recruitment status was: Recruiting
First Posted : August 15, 2016
Last Update Posted : August 15, 2016
|Condition or disease||Intervention/treatment||Phase|
|Asherman Syndrome||Device: Intrauterine balloon Device: Intrauterine contraceptive device||Not Applicable|
Intrauterine balloon and IUD are both effective in the therapy for intrauterine adhesion.
The IUD is usually inserted into the uterine after a hysteroscopic adhesiolysis and removed after two or three month later. Several investigators demonstrated its favorable effect in the recurrence of adhesion after the treatment of intrauterine adhesion.
The heart-shaped intrauterine balloon is specially designed to fit into the cavity of the uterus, and usually removed on the 7th day after surgery.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||A Randomized Clinical Trial to Assess the Efficacy of Intrauterine Balloon Compared to Intrauterine Contraceptive Device in the Therapy for Uterine Adhesion After Hysteroscopic Adhesiolysis|
|Study Start Date :||June 2015|
|Estimated Primary Completion Date :||February 2017|
|Estimated Study Completion Date :||June 2017|
Experimental: Intrauterine balloon
The heart-shaped intrauterine balloon is designed to fit into the cavity of the uterus,and removed on the 7th day after surgery. And hysteroscopy was taken out again after two menstrual cycles to evaluate the uterine adhesions.
Device: Intrauterine balloon
After the completion of hysteroscopic adhesiolysis, intrauterine balloon was inserted and inflated with 3-5 mL normal saline which was removed after 1 week.
Other Name: COOK balloon
Experimental: Intrauterine contraceptive device
The IUD is inserted into the uterine after a hysteroscopic adhesiolysis and removed at the second hysteroscopy. Uterine adhesions were judged again at the second hysteroscopy.
Device: Intrauterine contraceptive device
After the completion of hysteroscopic adhesiolysis, copper IUD was inserted into the uterine cavity and removed after at the second time of hysteroscopy.
Other Name: IUD
- The change of AFS score （The American Fertility Society classifications）in two menstrual cycles [ Time Frame: baseline and two months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02867202
|Contact: Feng Lin, MDfirstname.lastname@example.org|
|Contact: Yuanqiu Wang, MDemail@example.com|
|the 1st Affiliated Hospital of Wenzhou Medical University||Recruiting|
|Wenzhou, Zhejiang, China, 325000|
|Contact: Feng Lin, MD 0886-0577-88069525 firstname.lastname@example.org|
|Principal Investigator: Feng Lin, MD|
|Principal Investigator:||Feng Lin, MD||the 1st Affiliated Hospital of Wenzhou Medical University|