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

Not Applicable

Active, not recruiting

• Conditions: Myoma;Uterus; Uterine Septum; Hysteroscopy; Retained Products of Conception; Adhesion; Infertility; Polyp Uterus
• Interventions: Device: Hyalobarrier® gel endo

• Registration Number: NCT03880435
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2019-03-12
• Study First Submitted QC: 2019-03-18
• Study First Posted: 2019-03-19
• Study Start: 2019-04-01
• Primary Completion: 2024-06-30
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-29
• Last Update Posted: 2024-07-30
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 419

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hyalobarrier® gel endo	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)

Primary Outcome Measures

Name	Time	Method
Conception leading to live birth	> 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

Name	Time	Method
Ectopic pregnancy	< 30 weeks after receiving treatment allocation	a pregnancy in which implantation takes place outside the uterine cavity
Preterm birth	> 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
Clinical pregnancy	< 30 weeks after receiving treatment allocation	An ultrasound visible gestational sac
Pre-eclampsia	> 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
The total hospital bill	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
Low/very low birth weight (gram)	> 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
Time to conception	< 30 weeks after receiving treatment allocation	the time from receiving the allocated treatment to the date of conception
Miscarriage	< 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
Adhesions	> 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
Stilbirth	> 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
Caesarean section rates	> 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
Neonatal complications	> 30 weeks after receiving treatment allocation	Neonatal complications in women who conceived during the study period,

Trial Locations

Locations (1)

University hospital Ghent; 🇧🇪 Ghent, East-Flanders, Belgium