HYALOBARRIER® GEL ENDO Versus no HYALOBARRIER® GEL ENDO Following Operative Hysteroscopy for Improving Reproductive Outcome in Women With Intrauterine Pathology Wishing to Become Pregnant

NCT03880435 | Active Not Recruiting DMC

• 1 other identifier: AGNOHSTIC
• Study Type: interventional
• Target: 419
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the costs and effects of HYALOBARRIER® GEL ENDO versus no HYALOBARRIER® GEL ENDO for increasing the chance of conception leading to live birth measured at 30 weeks after randomization in women wishing to become pregnant after surgical removal of intrauterine pathology (endometrial polyps, fibroids with uterine cavity deformation, uterine septa, IUAs or RPOC after miscarriage) by hysteroscopy as an outpatient or in hospital treatment.

Conditions

Infertility; Polyp Uterus; Myoma;Uterus; Adhesion; Hysteroscopy; Uterine Septum; Retained Products of Conception

Keywords

Infertility; Reproductive outcome; Hysteroscopy; Adhesion prophylaxis

Outcome Measures

Primary Outcomes (1)

• Conception leading to live birth

  the amount of clinical pregnancies at 30 weeks after randomisation, leading to live birth (at least one live foetus after 20 weeks of gestation, that resulted in at least one live baby (the investigators counted the delivery of singleton, twin or multiple pregnancies as one live birth)

  > 30 weeks after randomisation

Secondary Outcomes (12)

• Time to conception

  < 30 weeks after receiving treatment allocation

• Clinical pregnancy

  < 30 weeks after receiving treatment allocation

• Miscarriage

  < 30 weeks after receiving treatment allocation

• Ectopic pregnancy

  < 30 weeks after receiving treatment allocation

• Adhesions

  > 30w after receiving treatment allocation (in women who failed to conceive)

Study Arms (2)

Hyalobarrier® gel endo

EXPERIMENTAL

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)

Device: Hyalobarrier® gel endo

No Hyalobarrier® gel endo

NO INTERVENTION

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)

Interventions

Hyalobarrier® gel endo DEVICE

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

Hyalobarrier® gel endo

Eligibility Criteria

• Age: 18 Years - 47 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women aged 18 to 47 years attending Belgian fertility clinics, scheduled for operative hysteroscopy for endometrial polyps, fibroids with uterine cavity deformation, uterine septa, intrauterine adhesions (IUAs) and 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.

You may not qualify if:

• Women younger than 18 years
• 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.

Sponsors & Collaborators

• University Hospital, Ghent: lead
• Belgium Health Care Knowledge Centre: collaborator
• Nordic Pharma SAS: collaborator
• Universitaire Ziekenhuizen KU Leuven: collaborator
• Universitair Ziekenhuis Brussel: collaborator
• Health, Innovation and Research Institute (HIRUZ) UZ Ghent: collaborator
• University of Liege: collaborator
• UCL Bruxelles: collaborator
• Jessa hospital, Hasselt: collaborator

Study Sites (1)

University hospital Ghent

Ghent, East-Flanders, 9000, Belgium

Location

Related Publications (12)

• 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.

  PMID: 12923149 BACKGROUND

• 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.

  PMID: 26559098 BACKGROUND

• 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.

  PMID: 16603437 BACKGROUND

• 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.

  PMID: 21777835 BACKGROUND

• 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.

  PMID: 20540664 BACKGROUND

• 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.

  PMID: 17636653 BACKGROUND

• 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.

  PMID: 12923157 BACKGROUND

• 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.

  PMID: 15105384 BACKGROUND

• 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.

  PMID: 10908775 BACKGROUND

• 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.

  PMID: 21310749 BACKGROUND

• 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.

  PMID: 26783243 BACKGROUND

• 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.

  PMID: 15760959 BACKGROUND

MeSH Terms

Conditions

Infertility; Myofibroma; Tissue Adhesions; Septate Uterus

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Uterine Duplication Anomalies; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications

Study Officials

• Steven Weyers, MD,PhD

  Women's Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: None of the participants will be informed of the allocated treatment by the surgeon performing the operative hysteroscopy or the personnel present in the OR. The medical record will not reveal any information whether HYALOBARRIER® GEL ENDO was applied at the end of the procedure. The REDCap software will automatically document the allocation and store all the records and the randomisations. The gynaecologist doing the operative hysteroscopy should not be the same as the fertility physician and the gynaecologist doing the second look hysteroscopy. In the exceptional case that the surgeon doing the operative hysteroscopy is the same person as the fertility physician or the gynaecologist doing the second-look hysteroscopy, blinding is assured by notification of treatment allocation if the surgeon has left the operating room.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2019
• First Posted: March 19, 2019
• Study Start: April 1, 2019
• Primary Completion: June 30, 2024
• Study Completion: May 31, 2025
• Last Updated: July 30, 2024

Record last verified: 2024-07

Locations

BE (1)