An interventional study of Hyalobarrier® gel endo in Infertility, Polyp Uterus and Myoma;Uterus, sponsored by University Hospital, Ghent. Active, not recruiting at 1 site in Belgium. Open to female participants aged 18 Years to 47 Years. Per ClinicalTrials.gov, last updated 2024-07-30.
Sponsored by University Hospital, Ghent · Not applicable, Interventional, and Prevention
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.
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.
490 studies on the registry are indexed under Leiomyoma; 81 are open to participants now.
This study's enrollment of 419 is above the median of 62 across 345 interventional studies indexed under Leiomyoma.
Browse Leiomyoma studies →University Hospital, Ghent is the lead sponsor of 665 studies on the registry; 156 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
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:
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 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)
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
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)
Time frame: > 30 weeks after randomisation
Time to conception
the time from receiving the allocated treatment to the date of conception
Time frame: < 30 weeks after receiving treatment allocation
Clinical pregnancy
An ultrasound visible gestational sac
Time frame: < 30 weeks after receiving treatment allocation
Miscarriage
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
Time frame: < 30 weeks after receiving treatment allocation
Ectopic pregnancy
a pregnancy in which implantation takes place outside the uterine cavity
Time frame: < 30 weeks after receiving treatment allocation
Adhesions
The severity will be scored according to the revised American Fertility Society (AFS) scoring system
Time frame: > 30w after receiving treatment allocation (in women who failed to conceive)
Pre-eclampsia
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 receiving treatment allocation
Preterm birth
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 receiving treatment allocation
Stilbirth
Stillbirth in women who conceived during the study period, leading to an ongoing pregnancy beyond 20 weeks of gestation
Time frame: > 30 weeks after receiving treatment allocation
Low/very low birth weight (gram)
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 receiving treatment allocation
Caesarean section rates
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 receiving treatment allocation
Neonatal complications
Neonatal complications in women who conceived during the study period,
Time frame: > 30 weeks after receiving treatment allocation
The total hospital bill
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
This study is active, not recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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University Hospital, Ghent