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

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ClinicalTrials.gov Identifier: NCT03880435
Recruitment Status : Recruiting
First Posted : March 19, 2019
Last Update Posted : May 9, 2019
Sponsor:
Collaborators:
Belgium Health Care Knowledge Centre
Nordic Pharma SAS
Universitaire Ziekenhuizen Leuven
Universitair Ziekenhuis Brussel
Imelda Hospital, Bonheiden
CTC BIMETRA
University of Liège
UCL Bruxelles
Information provided by (Responsible Party):
University Hospital, Ghent

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.

Condition or disease Intervention/treatment Phase
Infertility Polyp Uterus Myoma;Uterus Adhesion Hysteroscopy Uterine Septum Retained Products of Conception Device: Hyalobarrier® gel endo Not Applicable

Detailed Description:

Design:

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 randomisation long term follow-up: 66 weeks after randomisation

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: 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. The surgeon should under no condition disclose any information on the allocated treatment to another party.
Primary Purpose: Prevention
Official Title: The Cost-effectiveness of Anti-adhesion Treatment With HYALOBARRIER® GEL ENDO Versus no Gel Following the Removal by Hysteroscopy of Endometrial Polyps, Fibroids With Uterine Cavity Deformation, Uterine Septa, Intrauterine Adhesions or Retained Products of Conception for Improving Reproductive Outcome in Women Wishing to Become Pregnant: a Multi-centre, Parallel Group, Superiority, Double-blind, Randomized Controlled Trial
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : November 1, 2019
Estimated Study Completion Date : May 26, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adhesions

Arm Intervention/treatment
Experimental: Hyalobarrier® gel endo
Application of Hyalobarrier® gel endo immediate 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)
Device: Hyalobarrier® gel endo
Intra-uterine application of 10ml sterile gel containing 30mg APC. It will be administered once, preoperatively immediate after the hysteroscopic removal of the polyp, myoma, adhesion, uterine septum or retained products of conception

No Intervention: 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)



Primary Outcome Measures :
  1. Conception leading to live birth [ Time Frame: > 30 weeks after randomisation ]
    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)


Secondary Outcome Measures :
  1. Time to conception [ Time Frame: < 30 weeks after randomisation ]
    the time from study entry (randomisation) to the date of conception

  2. Clinical pregnancy [ Time Frame: < 30 weeks after randomisation ]
    An ultrasound visible gestational sac

  3. Miscarriage [ Time Frame: < 30 weeks after randomisation ]
    as spontaneous loss of pregnancy before 20 completed weeks of gestational age or, if gestational age is unknown, the loss of an embryo /foetus of less than 400 grams

  4. Ectopic pregnancy [ Time Frame: < 30 weeks after randomisation ]
    a pregnancy in which implantation takes place outside the uterine cavity

  5. Adhesions [ Time Frame: > 30w after randomisation (in women who failed to conceive) ]
    The severity will be scored according to the revised American Fertility Society (AFS) scoring system

  6. Pre-eclampsia in women who conceived during the study period, leading to an ongoing pregnancy beyond 20 weeks of gestation [ Time Frame: > 30 weeks after randomisation ]
    pre-eclampsia,

  7. Preterm birth in women who conceived during the study period, leading to an ongoing pregnancy beyond 20 weeks of gestation [ Time Frame: > 30 weeks after randomisation ]
    preterm birth

  8. Stilbirth in women who conceived during the study period, leading to an ongoing pregnancy beyond 20 weeks of gestation [ Time Frame: > 30 weeks after randomisation ]
    stillbirth

  9. Low/very low birth weight (gram) in women who conceived during the study period, leading to an ongoing pregnancy beyond 20 weeks of gestation [ Time Frame: > 30 weeks after randomisation ]
    low/very low birth weight (gram)

  10. Caesarean section rates in women who conceived during the study period, leading to an ongoing pregnancy beyond 20 weeks of gestation [ Time Frame: > 30 weeks after randomisation ]
    caesarean section rates

  11. Neonatal complications in women who conceived during the study period, leading to an ongoing pregnancy beyond 20 weeks of gestation [ Time Frame: > 30 weeks after randomisation ]
    neonatal complications

  12. Direct health-related costs [ Time Frame: measured at the time of diagnosis of an ongoing pregnancy by the detection at 12 weeks in a clinical pregnancy of a positive heart beat on ultrasound examination ]
    The total hospital bill



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 47 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03880435


Contacts
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Contact: Eline Meireson, MSc +32 (0)9 332 78 17 eline.meireson@uzgent.be
Contact: Sofie Van den Abeele, MSc 093327817 sofie.vandenabeele@uzgent.be

Locations
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Belgium
University hospital Ghent Recruiting
Ghent, East-Flanders, Belgium, 9000
Contact: Eline Meireson, Msc    003293327817    eline.meireson@uzgent.be   
Sponsors and Collaborators
University Hospital, Ghent
Belgium Health Care Knowledge Centre
Nordic Pharma SAS
Universitaire Ziekenhuizen Leuven
Universitair Ziekenhuis Brussel
Imelda Hospital, Bonheiden
CTC BIMETRA
University of Liège
UCL Bruxelles
Investigators
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Principal Investigator: Steven Weyers, MD,PhD Women's Clinic

Publications:

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Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT03880435     History of Changes
Other Study ID Numbers: AGNOHSTIC
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: May 9, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Ghent:
Infertility
Reproductive outcome
Hysteroscopy
Adhesion prophylaxis

Additional relevant MeSH terms:
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Infertility
Polyps
Tissue Adhesions
Leiomyoma
Myofibroma
Genital Diseases, Male
Genital Diseases, Female
Pathological Conditions, Anatomical
Cicatrix
Fibrosis
Pathologic Processes
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases