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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Infertility, Polyp Uterus, Myoma;Uterus, Adhesion, Hysteroscopy, Uterine Septum, Retained Products of Conception

Intervention / Treatment
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* Device: Hyalobarrier® gel endo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 47 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hyalobarrier® gel endo<br>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<br>* 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<br>|
| No Intervention: No Hyalobarrier® gel endo<br>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) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | > 30 weeks after randomisation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to conception | the time from receiving the allocated treatment to the date of conception | < 30 weeks after receiving treatment allocation | 
| Clinical pregnancy | An ultrasound visible gestational sac | < 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 | < 30 weeks after receiving treatment allocation | 
| Ectopic pregnancy | a pregnancy in which implantation takes place outside the uterine cavity | < 30 weeks after receiving treatment allocation | 
| Adhesions | The severity will be scored according to the revised American Fertility Society (AFS) scoring system | > 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 | > 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 | > 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 | > 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 | > 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 | > 30 weeks after receiving treatment allocation | 
| Neonatal complications | Neonatal complications in women who conceived during the study period, | > 30 weeks after receiving treatment allocation | 
| The total hospital bill | Direct health-related costs | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infertility, Reproductive outcome, Hysteroscopy, Adhesion prophylaxis