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NCT Number: NCT03880435

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Infertility Adhesion Cicatrix Connective Tissue Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fibrosis Genital Diseases Genital Diseases, Female Hysteroscopy Myofibroma Myoma;Uterus Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Pathologic Processes Pathological Conditions, Signs and Symptoms Polyp Uterus Retained Products of Conception Septate Uterus Skin and Connective Tissue Diseases Tissue Adhesions Urogenital Diseases Uterine Diseases Uterine Duplication Anomalies Uterine Septum

Age range

18 year–47 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University hospital Ghent

Ghent, East-Flanders, 9000, Belgium

About this study

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 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  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 outcomes

  1. Time to conception

    Time frame: < 30 weeks after receiving treatment allocation

    the time from receiving the allocated treatment to the date of conception

  2. Clinical pregnancy

    Time frame: < 30 weeks after receiving treatment allocation

    An ultrasound visible gestational sac

  3. Miscarriage

    Time frame: < 30 weeks after receiving treatment allocation

    a spontaneous loss of pregnancy before 20 completed weeks of gestational age, or if gestational age is unknown, the loss of an embryo/fetus of less than 400 grams

  4. Ectopic pregnancy

    Time frame: < 30 weeks after receiving treatment allocation

    a pregnancy in which implantation takes place outside the uterine cavity

  5. Adhesions

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

    The severity will be scored according to the revised American Fertility Society (AFS) scoring system

  6. Pre-eclampsia

    Time frame: > 30 weeks after receiving treatment allocation

    Pre-eclampsia in women who conceived during the study period, leading to an ongoing pregnancy beyond 20 weeks of gestation

  7. Preterm birth

    Time frame: > 30 weeks after receiving treatment allocation

    Preterm birth in women who conceived during the study period, leading to an ongoing pregnancy beyond 20 weeks of gestation

  8. Stilbirth

    Time frame: > 30 weeks after receiving treatment allocation

    Stillbirth in women who conceived during the study period, leading to an ongoing pregnancy beyond 20 weeks of gestation

  9. Low/very low birth weight (gram)

    Time frame: > 30 weeks after receiving treatment allocation

    low/very low birth weight (gram) in women who conceived during the study period, leading to an ongoing pregnancy beyond 20 weeks of gestation

  10. Caesarean section rates

    Time frame: > 30 weeks after receiving treatment allocation

    caesarean section rates in women who conceived during the study period, leading to an ongoing pregnancy beyond 20 weeks of gestation

  11. Neonatal complications

    Time frame: > 30 weeks after receiving treatment allocation

    Neonatal complications in women who conceived during the study period,

  12. The total hospital bill

    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

    Direct health-related costs

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

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

Registry information

Official study 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

Acronym: AGNOHSTIC

Important dates

Study start
2019
Primary completion
2024
Study completion
2025
First posted
Mar 19, 2019
Registry last updated
Jul 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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