Adhesion, Hysteroscopy, Infertility, Myoma;Uterus, Polyp Uterus, Retained Products of Conception, Uterine Septum
Conditions
Keywords
Infertility, Reproductive outcome, Hysteroscopy, Adhesion prophylaxis
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.
Interventions
DEVICEHyalobarrier® gel endo
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
Sponsors
Belgium Health Care Knowledge Centre
Nordic Pharma SAS
Universitaire Ziekenhuizen KU Leuven
Universitair Ziekenhuis Brussel
Health, Innovation and Research Institute (HIRUZ) UZ Ghent
University of Liege
UCL Bruxelles
Jessa hospital, Hasselt
University Hospital, Ghent
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
None of the participants will be informed of the allocated treatment by the surgeon performing the operative hysteroscopy or the personnel present in the OR. The medical record will not reveal any information whether HYALOBARRIER® GEL ENDO was applied at the end of the procedure. The REDCap software will automatically document the allocation and store all the records and the randomisations. The gynaecologist doing the operative hysteroscopy should not be the same as the fertility physician and the gynaecologist doing the second look hysteroscopy. In the exceptional case that the surgeon doing the operative hysteroscopy is the same person as the fertility physician or the gynaecologist doing the second-look hysteroscopy, blinding is assured by notification of treatment allocation if the surgeon has left the operating room.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 47 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Clinical pregnancy | < 30 weeks after receiving treatment allocation | An ultrasound visible gestational sac |
| 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 |
| Ectopic pregnancy | < 30 weeks after receiving treatment allocation | a pregnancy in which implantation takes place outside the uterine cavity |
| 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 |
| 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 |
| Time to conception | < 30 weeks after receiving treatment allocation | the time from receiving the allocated treatment to the date of conception |
| 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 |
| 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 |
| 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, |
| 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 |
| 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 |
Countries
Belgium
Outcome results
None listed