HYALOBARRIER® GEL ENDO Versus no HYALOBARRIER® GEL ENDO Following Operative Hysteroscopy for Improving Reproductive Outcome in Women With Intrauterine Pathology Wishing to Become Pregnant
NCT ID: NCT03880435
Last Updated: 2024-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
NA
419 participants
INTERVENTIONAL
2019-04-01
2025-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Intrauterine Adhesion Rate After Hysteroscopic Myomectomy and Application of HYALOBARRIER Gel
NCT01412489
Prevention of Intra-uterine Adhesions Following Laparoscopic and Laparotomic Myomectomy
NCT05683041
Safety and Performance of the Semical Adhesion Barrier Gel for Prevention of Intra-uterine Adhesion
NCT07160764
Study to Compare Peritoneal Ablation by Excision Only and Excision With the Use of an Adhesion Barrier
NCT02165917
ExAblate Treatment of Uterine Fibroids for Fertility Enhancement
NCT00730886
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Multi-centre, parallel group, superiority, double-blind, randomized controlled trial. Post market study of a Medical Device class III.
Participant:
Women aged 18 to 47 years attending Belgian gynaecological departments, scheduled for operative hysteroscopy for endometrial polyps, fibroids with uterine cavity deformation, uterine septa, intrauterine adhesions (IUAs) or retained products of conception, and wishing to conceive spontaneously or before fertility treatment with ovulation induction (OI), controlled ovarian stimulation (COS), intrauterine insemination (IUI) or IVF/ICSI.
Treatment:
Application of Hyalobarrier® gel endo at time of surgery
Control:
No application of Hyalobarrier® gel endo
Follow up:
short term follow-up: 30 weeks after receiving the treatment allocation long term follow-up: 66 weeks after receiving the treatment allocation
To blind all trial participants, fertility physicians and gynaecologists doing second- or third-look hysteroscopy, 10 ml of a sterile ultrasound gel will be applied into the vagina at the end of the procedure in all women regardless of their treatment allocation.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Hyalobarrier® gel endo
Application of Hyalobarrier® gel endo immediate after the complete hysteroscopic removal of the polyp, myoma, adhesion, uterine septum or retained products of conception + application of sterile ultrasound gel into the vagina (to blind all trial participants, fertility physicians and gynaecologists doing second-look hysteroscopy)
Hyalobarrier® gel endo
Intra-uterine application of 10ml sterile gel containing 30mg APC. It will be administered once, peroperatively immediate after the complete hysteroscopic removal of the polyp, myoma, adhesion, uterine septum or retained products of conception
No Hyalobarrier® gel endo
No application of Hyalobarrier® gel endo after the hysteroscopic removal of the polyp, myoma, adhesion, uterine septum or retained products of conception + application of sterile ultrasound gel into the vagina (to blind all trial participants, fertility physicians and gynaecologists doing second- or third-look hysteroscopy)
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Hyalobarrier® gel endo
Intra-uterine application of 10ml sterile gel containing 30mg APC. It will be administered once, peroperatively immediate after the complete hysteroscopic removal of the polyp, myoma, adhesion, uterine septum or retained products of conception
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* Women 48 years of age or older
* Women with a known allergy to HYALOBARRIER® GEL ENDO
* Women with an active infection of the genital tract proven by genital swabs for PCR (Chlamydia, gonococci) or endometrial biopsy (endometritis), not treated at the time of the pre- screening visit. Women adequately treated with proven cure (negative swabs or normal endometrial biopsy) can be included
* Subserosal fibroids (FIGO or PALM-COEIN classification type 6, 7) - leiomyomas that originate from the myometrium at the serosa of the uterus or intramural fibroids without uterine cavity deformation as documented by ultrasound, hysterography or hysteroscopy - as the sole uterine cavity abnormality identified in the screening phase.
* Women with fibroids, polyps, uterine septa or IUAs suffering from other symptoms, for instance abnormal uterine bleeding, but not wishing to conceive from 6 weeks following surgery
* Women with other Müllerian tract anomalies other than a uterine septum as the sole uterine cavity abnormality identified in the screening phase
* Women who participated in the trial but failed to conceive and who present with a recurrence of polyps, fibroids with cavity deformation, uterine septum or IUAs
* Women who refuse to give written informed consent.
18 Years
47 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Belgium Health Care Knowledge Centre
OTHER_GOV
Nordic Pharma SAS
INDUSTRY
Universitaire Ziekenhuizen KU Leuven
OTHER
Universitair Ziekenhuis Brussel
OTHER
Health, Innovation and Research Institute (HIRUZ) UZ Ghent
UNKNOWN
University of Liege
OTHER
UCL Bruxelles
UNKNOWN
Jessa hospital, Hasselt
UNKNOWN
University Hospital, Ghent
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Steven Weyers, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Women's Clinic
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University hospital Ghent
Ghent, East-Flanders, Belgium
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Acunzo G, Guida M, Pellicano M, Tommaselli GA, Di Spiezio Sardo A, Bifulco G, Cirillo D, Taylor A, Nappi C. Effectiveness of auto-cross-linked hyaluronic acid gel in the prevention of intrauterine adhesions after hysteroscopic adhesiolysis: a prospective, randomized, controlled study. Hum Reprod. 2003 Sep;18(9):1918-21. doi: 10.1093/humrep/deg368.
Bosteels J, Weyers S, Kasius J, Broekmans FJ, Mol BW, D'Hooghe TM. Anti-adhesion therapy following operative hysteroscopy for treatment of female subfertility. Cochrane Database Syst Rev. 2015 Nov 9;(11):CD011110. doi: 10.1002/14651858.CD011110.pub2.
Casini ML, Rossi F, Agostini R, Unfer V. Effects of the position of fibroids on fertility. Gynecol Endocrinol. 2006 Feb;22(2):106-9. doi: 10.1080/09513590600604673.
Di Spiezio Sardo A, Spinelli M, Bramante S, Scognamiglio M, Greco E, Guida M, Cela V, Nappi C. Efficacy of a polyethylene oxide-sodium carboxymethylcellulose gel in prevention of intrauterine adhesions after hysteroscopic surgery. J Minim Invasive Gynecol. 2011 Jul-Aug;18(4):462-9. doi: 10.1016/j.jmig.2011.04.007.
Farhi J, Orvieto R. Cumulative clinical pregnancy rates after COH and IUI in subfertile couples. Gynecol Endocrinol. 2010 Jul;26(7):500-4. doi: 10.3109/09513590903367036.
Farquhar C, Lilford RJ, Marjoribanks J, Vandekerckhove P. Laparoscopic 'drilling' by diathermy or laser for ovulation induction in anovulatory polycystic ovary syndrome. Cochrane Database Syst Rev. 2007 Jul 18;(3):CD001122. doi: 10.1002/14651858.CD001122.pub3.
Gnoth C, Godehardt D, Godehardt E, Frank-Herrmann P, Freundl G. Time to pregnancy: results of the German prospective study and impact on the management of infertility. Hum Reprod. 2003 Sep;18(9):1959-66. doi: 10.1093/humrep/deg366.
Guida M, Acunzo G, Di Spiezio Sardo A, Bifulco G, Piccoli R, Pellicano M, Cerrota G, Cirillo D, Nappi C. Effectiveness of auto-crosslinked hyaluronic acid gel in the prevention of intrauterine adhesions after hysteroscopic surgery: a prospective, randomized, controlled study. Hum Reprod. 2004 Jun;19(6):1461-4. doi: 10.1093/humrep/deh238. Epub 2004 Apr 22.
Jansen FW, Vredevoogd CB, van Ulzen K, Hermans J, Trimbos JB, Trimbos-Kemper TC. Complications of hysteroscopy: a prospective, multicenter study. Obstet Gynecol. 2000 Aug;96(2):266-70. doi: 10.1016/s0029-7844(00)00865-6.
Kasius JC, Broekmans FJ, Veersema S, Eijkemans MJ, van Santbrink EJ, Devroey P, Fauser BC, Fatemi HM. Observer agreement in the evaluation of the uterine cavity by hysteroscopy prior to in vitro fertilization. Hum Reprod. 2011 Apr;26(4):801-7. doi: 10.1093/humrep/der003. Epub 2011 Feb 9.
McLernon DJ, Maheshwari A, Lee AJ, Bhattacharya S. Cumulative live birth rates after one or more complete cycles of IVF: a population-based study of linked cycle data from 178,898 women. Hum Reprod. 2016 Mar;31(3):572-81. doi: 10.1093/humrep/dev336. Epub 2016 Jan 18.
Perez-Medina T, Bajo-Arenas J, Salazar F, Redondo T, Sanfrutos L, Alvarez P, Engels V. Endometrial polyps and their implication in the pregnancy rates of patients undergoing intrauterine insemination: a prospective, randomized study. Hum Reprod. 2005 Jun;20(6):1632-5. doi: 10.1093/humrep/deh822. Epub 2005 Mar 10.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AGNOHSTIC
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.