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

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Abstract
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 (R) 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 (R) 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 resulted in a higher pain score compared with a sham procedure (visual analogue scale score 2.7 [1.3-3.5] vs. 1.0 [0.0-2.0], P<0.001). There were two adverse events after GIS compared with none after sham procedures. LIMITATIONS, REASONS FOR CAUTION: The study was terminated prematurely due to slow recruitment and trial fatigue. Therefore, the trial is underpowered to draw definite conclusions regarding the effect of uterine bathing with sonography gel on live birth rate after fresh embryo transfer in endometriosis patients undergoing IVF/ICSI-treatment. WIDER IMPLICATIONS OF THE FINDINGS: We could not demonstrate a favourable effect of uterine bathing procedures with sonography gel prior to IVF/ICSI-treatment in patients with endometriosis.
Keywords
endometriosis, IVF/ICSI, ART, implantation, uterine bathing, endometrium, pregnancy, live birth, RECURRENT IMPLANTATION FAILURE, EUTOPIC ENDOMETRIUM, PREGNANCY RATES, LOCAL INJURY, LIPIODOL, WOMEN, HYSTEROSCOPY, FOAM

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MLA
Lier, M. C. I., et al. “Uterine Bathing with Sonography Gel Prior to IVF/ICSI-Treatment in Patients with Endometriosis, a Multicentre Randomised Controlled Trial.” HUMAN REPRODUCTION OPEN, vol. 2020, no. 4, 2020, doi:10.1093/hropen/hoaa054.
APA
Lier, M. C. I., Özcan, H., Schreurs, A. M. F., van de Ven, P. M., Dreyer, K., van der Houwen, L. E. E., … Mijatovic, V. (2020). Uterine bathing with sonography gel prior to IVF/ICSI-treatment in patients with endometriosis, a multicentre randomised controlled trial. HUMAN REPRODUCTION OPEN, 2020(4). https://doi.org/10.1093/hropen/hoaa054
Chicago author-date
Lier, M. C. I., H. Özcan, A. M. F. Schreurs, P. M. van de Ven, K. Dreyer, L. E. E. van der Houwen, N. P. Johnson, et al. 2020. “Uterine Bathing with Sonography Gel Prior to IVF/ICSI-Treatment in Patients with Endometriosis, a Multicentre Randomised Controlled Trial.” HUMAN REPRODUCTION OPEN 2020 (4). https://doi.org/10.1093/hropen/hoaa054.
Chicago author-date (all authors)
Lier, M. C. I., H. Özcan, A. M. F. Schreurs, P. M. van de Ven, K. Dreyer, L. E. E. van der Houwen, N. P. Johnson, Frank Vandekerckhove, H. R. Verhoeve, W. Kuchenbecker, B. W. Mol, Cornelis Lambalk, and V. Mijatovic. 2020. “Uterine Bathing with Sonography Gel Prior to IVF/ICSI-Treatment in Patients with Endometriosis, a Multicentre Randomised Controlled Trial.” HUMAN REPRODUCTION OPEN 2020 (4). doi:10.1093/hropen/hoaa054.
Vancouver
1.
Lier MCI, Özcan H, Schreurs AMF, van de Ven PM, Dreyer K, van der Houwen LEE, et al. Uterine bathing with sonography gel prior to IVF/ICSI-treatment in patients with endometriosis, a multicentre randomised controlled trial. HUMAN REPRODUCTION OPEN. 2020;2020(4).
IEEE
[1]
M. C. I. Lier et al., “Uterine bathing with sonography gel prior to IVF/ICSI-treatment in patients with endometriosis, a multicentre randomised controlled trial,” HUMAN REPRODUCTION OPEN, vol. 2020, no. 4, 2020.
@article{8702423,
  abstract     = {{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 (R) 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 (R) 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 resulted in a higher pain score compared with a sham procedure (visual analogue scale score 2.7 [1.3-3.5] vs. 1.0 [0.0-2.0], P<0.001). There were two adverse events after GIS compared with none after sham procedures.
LIMITATIONS, REASONS FOR CAUTION: The study was terminated prematurely due to slow recruitment and trial fatigue. Therefore, the trial is underpowered to draw definite conclusions regarding the effect of uterine bathing with sonography gel on live birth rate after fresh embryo transfer in endometriosis patients undergoing IVF/ICSI-treatment.
WIDER IMPLICATIONS OF THE FINDINGS: We could not demonstrate a favourable effect of uterine bathing procedures with sonography gel prior to IVF/ICSI-treatment in patients with endometriosis.}},
  articleno    = {{hoaa054}},
  author       = {{Lier, M. C. I. and Özcan, H. and Schreurs, A. M. F. and van de Ven, P. M. and Dreyer, K. and van der Houwen, L. E. E. and Johnson, N. P. and Vandekerckhove, Frank and Verhoeve, H. R. and Kuchenbecker, W. and Mol, B. W. and Lambalk, Cornelis and Mijatovic, V.}},
  issn         = {{2399-3529}},
  journal      = {{HUMAN REPRODUCTION OPEN}},
  keywords     = {{endometriosis,IVF/ICSI,ART,implantation,uterine bathing,endometrium,pregnancy,live birth,RECURRENT IMPLANTATION FAILURE,EUTOPIC ENDOMETRIUM,PREGNANCY RATES,LOCAL INJURY,LIPIODOL,WOMEN,HYSTEROSCOPY,FOAM}},
  language     = {{eng}},
  number       = {{4}},
  pages        = {{10}},
  title        = {{Uterine bathing with sonography gel prior to IVF/ICSI-treatment in patients with endometriosis, a multicentre randomised controlled trial}},
  url          = {{http://doi.org/10.1093/hropen/hoaa054}},
  volume       = {{2020}},
  year         = {{2020}},
}

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