The IVF-LUBE trial – a randomized trial to assess Lipiodol® uterine bathing effect in women with endometriosis or repeat implantation failure undergoing IVF

Reilly, S; Glanville, Elizabeth; Dhorepatil, Bharati; Prentice, Lucy; Mol, Ben W.; Johnson, Neil

doi:10.1016/j.rbmo.2018.11.015

Cited by 15 publications

(14 citation statements)

References 14 publications

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“…And although observations in limited quality trials suggest that screening hysteroscopy might improve IVF/ICSI-treatment results ( Bosteels et al , 2010 ; Karayalçin et al , 2012 ; Kamath et al , 2019 ), performing uterine bathing with ExEm-gel ® is not endorsed by our study results. This is in accordance to the final report of the LUBE trial ( Reilly et al , 2019 ) in which no difference in success rates for IVF following uterine bathing with Lipiodol for women with endometriosis or RIF could be found. The trail of Salehpour et al (2016) in which intrauterine saline infusion as a form of endometrial injury was performed during IVF treatment even showed a negative effect on clinical pregnancy numbers and implantation rates among patients with RIF.…”

Section: Discussionsupporting

confidence: 91%

“…Because of the slow accrual of this trial and the IVF-LUBE trial concluding that uterine bathing with Lipiodol ® did not add to the success of IVF ( Reilly et al , 2019 ), it was decided to perform an interim analysis as soon as half of the planned study population had completed the study protocol. Details of the interim analysis were added to the trial protocol and approved by the institutional review board of the Amsterdam UMC (Location VUmc) before the required data became available.…”

Section: Methodsmentioning

confidence: 99%

“…Endometrial gene transcript regulation during Lipiodol ® uterine bathing has also demonstrated a downregulation of endometrial Osteopontin, a molecule that could be interfering with implantation receptivity in women with endometriosis ( Johnson et al, 2019 ). In order to investigate the effectiveness of pre-IVF uterine bathing with Lipiodol ® in women with endometriosis or RIF, the IVF-LUBE trial was performed ( Reilly et al , 2019 ). The study was, however, not sufficiently powered to show any difference between the intervention and control arm.…”

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Uterine bathing with sonography gel prior to IVF/ICSI-treatment in patients with endometriosis, a multicentre randomised controlled trial

Lier

Özcan

Schreurs

et al. 2020

Human Reproduction Open

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STUDY QUESTION What is the effect of uterine bathing with sonography gel prior to IVF/ICSI-treatment on live birth rates after fresh embryo transfer in patients with endometriosis? SUMMARY ANSWER After formal interim analysis and premature ending of the trial, no significant difference between uterine bathing using a pharmacologically neutral sonography gel compared to a sham procedure on live birth rate after fresh embryo transfer in endometriosis patients (26.7% vs. 15.4%, relative risk (RR) 1.73, 95% confidence interval (CI) 0.81–3.72; P- value 0.147) could be found, although the trial was underpowered to draw definite conclusions. WHAT IS KNOWN ALREADY Impaired implantation receptivity contributes to reduced clinical pregnancy rates after IVF/ICSI-treatment in endometriosis patients. Previous studies have suggested a favourable effect of tubal flushing with Lipiodol ® on natural conceptions. This benefit might also be explained by enhancing implantation through endometrial immunomodulation. Although recent studies showed no beneficial effect of endometrial scratching, the effect of mechanical stress by intrauterine infusion on the endometrium in endometriosis patients undergoing IVF/ICSI-treatment has not been investigated yet. STUDY DESIGN, SIZE, DURATION We performed a multicentre, patient-blinded, randomised controlled trial in which women were randomly allocated to either a Gel Infusion Sonography (GIS, intervention group) or a sham procedure (control group) prior to IVF/ICSI-treatment. Since recruitment was slow and completion of the study was considered unfeasible, the study was halted after inclusion of 112 of the planned 184 women. PARTICIPANTS/MATERIALS, SETTING, METHODS We included infertile women with surgically confirmed endometriosis ASRM stage I–IV undergoing IVF/ICSI-treatment. After informed consent, women were randomised to GIS with intrauterine instillation of ExEm-gel ® or sonography with gel into the vagina (sham). This was performed in the cycle preceding the embryo transfer, on the day GnRH analogue treatment was started. The primary endpoint was live birth rate after fresh embryo transfer. Analysis was performed by both intention-to-treat and per-protocol. MAIN RESULTS AND THE ROLE OF CHANCE Between July 2014 to September 2018, we randomly allocated 112 women to GIS (n = 60) or sham procedure (n = 52). The live birth rate after fresh embryo transfer was 16/60 (26.7%) after GIS versus 8/52 (15.4%) after the sham (RR 1.73, 95% CI 0.81–3.72; P -value 0.147). Ongoing pregnancy rate was 16/60 (26.7%) after GIS versus 9/52 (17.3%) in the controls (RR 1.54, 95% CI 0.74–3.18). Miscarriage occurred in 1/60 (1.7%) after GIS versus 5/52 (9.6%) in the controls (RR 0.17, 95% CI 0.02–1.44) women. Uterine bathing resu...

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Section: Discussionsupporting

confidence: 91%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Uterine bathing with sonography gel prior to IVF/ICSI-treatment in patients with endometriosis, a multicentre randomised controlled trial

Lier

Özcan

Schreurs

et al. 2020

Human Reproduction Open

View full text Add to dashboard Cite

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“…5,18 This theory has been used to assess whether Lipiodol improves the efficacy of in vitro fertilisation (IVF) procedures in 70 participants in the IVF LUBE study, with lower rates of IVF pregnancy found in the Lipiodol group (36% vs 49% IVF; P = 0.43). 23 In our study, six of the 20 women who conceived did so following ART. 24 Larger randomised studies assessing the fertility enhancing effect of Lipiodol flush on women undergoing subsequent ART are necessary.…”

Section: Discussionmentioning

confidence: 67%

Lipiodol flush under ultrasound guidance in Australia

Sekhon

Lee

et al. 2020

Aust NZ J Obst Gynaeco

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Infertility, the inability to conceive after one year of unprotected intercourse, 1 affects between 8-12% of couples worldwide. 1 The assessment of tubal patency under imaging is a necessary step in the investigation and treatment of infertility. 2 This can occur under radiologic guidance, referred to as hysterosalpingography (HSG), or under ultrasound guidance called hystero-salpingo contrast sonography (HyCoSy). Although a diagnostic procedure, several studies have shown improved pregnancy rates directly following HSG and HyCoSy, suggesting a therapeutic effect. 1,3,4 In order to ascertain tubal patency and uterine cavity shape, contrast media is injected via the cervix. The contrast media typically used is iodinated water (WSCM); however, oil-soluble contrast

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“…In this study a clinical pregnancy occurred in 1 out of the 20 women undergoing intrauterine saline infusion on days 3-5 in the stimulation phase as opposed to 9 out of 43 women without an infusion (p<0.05). In a randomized study [78] comparing uterine bathing with OSCM prior to IVF with IVF alone, no evidence was found of any beneficial effect.…”

Section: Enhancing the Chance Of Pregnancy?mentioning

confidence: 99%

Clinical Aspects of HyFoSy as Tubal Patency Test in Subfertility Workup

Exalto

Emanuel

2019

BioMed Research International

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Background. Tubal patency testing is an essential part of female subfertility evaluation. Traditionally, hysterosalpingography (HSG) was the first step to evaluate tubal patency. However, during the past decade Hysterosalpingo-Contrast Sonography (HyCoSy) was introduced in order to avoid radiation exposure and Hysterosalpingo-Foam Sonography (HyFoSy) has been developed as a safe and less painful alternative. Objectives and Rationale. The aim of this narrative review is to provide an overview of the currently available HyFoSy literature and related clinical aspects. Search Methods. A literature search was conducted using PubMed and Embase from the introduction of HyFoSy to March 2019. Unfortunately, a meta-analysis was not possible due to a too small number of studies, being mutually incomparable for the various subjects of clinical aspects, even for the reliability as a test for tubal patency. Outcomes. Nine small studies concluded that the accuracy and effectiveness as a test for tubal patency of 2D- and 3D-HyFoSy are comparable or even better than HSG or HyCoSy. With or without using Doppler techniques, 3D-HyFoSy does not seem to offer benefits above real-time 2D-HyFoSy. Five studies reported on pain and discomfort during HyFoSy, concluding that HyFoSy is a well-tolerated, less painful procedure compared to HSG, without a need for the use of analgesics. There are suggestions about an increased pregnancy rate in the first three cycles after the procedure but in no studies pregnancy outcome after HyFoSy was compared with other or no intervention. Wider Implications. HyFoSy is a promising and safe alternative for HSG with regard to accuracy and effectiveness. HyFoSy lacks radiation and iodine exposure and is a well-tolerated and less painful procedure than HSG, without the need for analgesics. However more research is needed to make clear statements regarding a therapeutic effect of HyFoSy.

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The IVF-LUBE trial – a randomized trial to assess Lipiodol® uterine bathing effect in women with endometriosis or repeat implantation failure undergoing IVF

Cited by 15 publications

References 14 publications

Uterine bathing with sonography gel prior to IVF/ICSI-treatment in patients with endometriosis, a multicentre randomised controlled trial

Uterine bathing with sonography gel prior to IVF/ICSI-treatment in patients with endometriosis, a multicentre randomised controlled trial

Lipiodol flush under ultrasound guidance in Australia

Clinical Aspects of HyFoSy as Tubal Patency Test in Subfertility Workup

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