Clinical trial 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
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Infertility
Polyp Uterus
Myoma;Uterus
Adhesion
Hysteroscopy
Uterine Septum
Retained Products of Conception
Keywords: Infertility
Reproductive outcome
Hysteroscopy
Adhesion prophylaxis
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: Belgium Health Care Knowledge Centre
name: Nordic Pharma SAS
name: Universitaire Ziekenhuizen KU Leuven
name: Universitair Ziekenhuis Brussel
name: Health, Innovation and Research Institute (HIRUZ) UZ Ghent
name: University of Liege
name: UCL Bruxelles
name: Jessa hospital, Hasselt
First posted: 2019-03-19
Enrollment: 419
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 47
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 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.

Eligibility 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.

Primary outcomes:
measure: Conception leading to live birth
timeFrame: > 30 weeks after randomisation
Secondary outcomes:
measure: Time to conception
timeFrame: < 30 weeks after receiving treatment allocation
measure: Clinical pregnancy
timeFrame: < 30 weeks after receiving treatment allocation
measure: Miscarriage
timeFrame: < 30 weeks after receiving treatment allocation
measure: Ectopic pregnancy
timeFrame: < 30 weeks after receiving treatment allocation
measure: Adhesions
timeFrame: > 30w after receiving treatment allocation (in women who failed to conceive)
measure: Pre-eclampsia
timeFrame: > 30 weeks after receiving treatment allocation
measure: Preterm birth
timeFrame: > 30 weeks after receiving treatment allocation
measure: Stilbirth
timeFrame: > 30 weeks after receiving treatment allocation
measure: Low/very low birth weight (gram)
timeFrame: > 30 weeks after receiving treatment allocation
measure: Caesarean section rates
timeFrame: > 30 weeks after receiving treatment allocation
measure: Neonatal complications
timeFrame: > 30 weeks after receiving treatment allocation
measure: The total hospital bill
timeFrame: 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
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University hospital Ghent
state: East-Flanders
Study officials:
affiliation: Women's Clinic
name: Steven Weyers, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
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