Eshre

1. Does routine hysteroscopy prior to the first IVF treatment
cycle improve live birth rates?
A randomized controlled trial: the inSIGHT study
J.G. Smit on behalf of the inSIGHT study group
Correspondence: jsmit6@umcutrecht.nl
Table 1| Baseline characteristics
Hysteroscopy
(n=371)
Immediate IVF
(n=378)
Age age (years) 33 (4.4) 33 (4.5)
Duration of subfertility (years) 2.6 (1.9) 2.7 (2.1)
Smoking 45 (12%) 67 (18%)
Primary subfertility 246 (66%) 241(64%)
Cause of subfertility
Unexplained 113 (30%) 104 (28%)
Male factor 179 (45%) 163 (43%)
Endometriosis 4 (1.1%) 12 (3.2%)
Tubal pathology 19 (5.1%) 26 (6.9%)
Anovulation 12 (3.2%) 34 (9.1%)
Combined 31 (8.4%) 31 (8.2%)
BMI 25 (4.2) 25 (4.3)
IVF: in vitro fertilization. Data are n(%), mean (SD)
Authors: J.G. Smit1, J.C. Kasius1, M.J.C. Eijkemans2, C.A.M. Koks3, R. van Golde4, A.W. Nap5, G.J. Scheffer6, P.A.P. Manger7, A. Hoek8, D.B.C. Schoot9, A.M. van Heusden10, W.K.H. Kuchenbecker11, D.A.M. Perquin12, K. Fleischer13, E.M. Kaaijk14, A. Sluijmer15, J. Friederich16, R.
Dykgraaf17, M. van Hooff18, L. Louwe19, J. Kwee20, C.H. de Koning21, I.C.A.H. Janssen22, F. Mol23, B.W.J. Mol24, H.L. Torrance1, F.J.M. Broekmans1.
Institutions: 1Department of Reproductive Medicine and Gynaecology, University Medical Center Utrecht, Utrecht, The Netherlands. 2 University Medical Center Utrecht, Julius Center for Health Sciences and Primary care, Utrecht, The Netherlands. 3 Department of
Obstetrics and Gynaecology, Maxima Medical Center, Veldhoven, The Netherlands. 4 Department of Obstetrics and Gynaecology, Maastricht University Medical Center, University of Maastricht, Maastricht, The Netherlands. 5 Department of Obstetrics and Gynaecology,
Rijnstate Hospital, Arnhem, The Netherlands. 6 Department of Obstetrics and Gynaecology, Gelre Hospital, Apeldoorn, The Netherlands. 7Department of Obstetrics and Gynaecology, Diakonessen Hospital Utrecht, Utrecht, The Netherlands. 8Department of Obstetrics
and Gynaecology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands. 9Department of Obstetrics and Gynaecology, Catharina Hospital, Eindhoven, The Netherlands. 10Department of Obstetrics and Gynaecology, Antonius
Hospital, Nieuwegein, The Netherlands. 11Department of Obstetrics and Gynaecology, Isala Clinics, Zwolle, The Netherlands. 12Department of Obstetrics and Gynaecology, Medical Center Leeuwarden, Leeuwarden, The Netherlands. 13Department of Obstetrics and
Gynaecology, University Medical Center St Radboud, Nijmegen, The Netherlands. 14Department of Obstetrics and Gynaecology, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands. 15Department of Obstetrics and Gynaecology, Wilhelmina Hospital, Assen, The
Netherlands. 16Department of Obstetrics and Gynaecology, Gemini Hospital, Den Helder, The Netherlands. 17Division of Reproductive Medicine, Department of Obstetrics and Gynaecology, Erasmus MC, Rotterdam, The Netherlands. 18Department of Obstetrics and
Gynaecology, Sint Franciscus Gasthuis, Rotterdam, The Netherlands. 19Department of Gynaecology and Reproductive Medicine, Leids University Medical Center, University of Leiden, Leiden, The Netherlands. 20Department of Obstetrics and Gynaecology, Sint Franciscus
Gasthuis, Rotterdam, The Netherlands. 21Department of Obstetrics and Gynaecology, Tergooi hospitals, Blaricum, The Netherlands. 22Groene Hart Hospital, Department of Obstetrics and Gynaecology, Gouda 23 Department of Obstetrics and Gynaecology, Academic
Medical Center, University of Amsterdam,Amsterdam,The Netherlands. 22The Robinson Institute, School of Paediatrics and ReproductiveHealth, University of Adelaide, 5000 SA, Australia.
INTRODUCTION
MATERIALS AND METHODS
RESULTS 1/2
• One complication was reported after
hysteroscopy (endometritis)
• Live birth was 55% in the hysteroscopy group
versus 51% in the immediate IVF group (RR:
1.08 (95% CI: 0.93 – 1.26)(table 2)
• The median time to pregnancy was 475 days
versus 419 days for the hysteroscopy and
immediate IVF group, respectively (p-
0.46)(figure 2)
Sponsor:
CONCLUSION
Hysteroscopy does not improve IVF outcome in subfertile women with a normal
transvaginal ultrasound
• Only 25% of the in vitro fertilisation (IVF)
cycles result in the birth of a child
• The etiology of implantation failure is poorly
understood
• Hysteroscopy is thought to improve ongoing
pregnancy rates in women entering an IVF
program
A randomised controlled trial was performed to
investigate the effectiveness of routine
hysteroscopy prior to the first IVF cycle
We performed a multicenter, non-blinded,
randomised controlled trial in 22 Dutch
hospitals.
Participants
Infertile women scheduled for a first IVF/ICSI
treatment with a normal transvaginal
ultrasound
Women with recurrent miscarriage, prior
hysteroscopy treatment or intermenstrual
blood loss were excluded
Table 2| Fertility outcomes
Hysteroscopy
(n=371)
Immediate IVF
(n=378)
RR (95% CI)
Live birth
18 months of FU 203 (55%) 191 (51%) 1.08 (0.93 – 1.26)
After first cycle* 88 (25%) 100 (29%) 0.95 (0.87 – 1.04)
Ongoing pregnancy 210 (57%) 200 (54%) 1.07 (0.91 – 1.26)
Clinical pregnancy 238 (64%) 221 (59%) 1.14 (0.95 – 1.37)
Multiple pregnancy 17 (8.4%) 8 (4.2%) 1.04 (0.99 – 1.10)
Miscarriage 63 (20%) 41 (15%) 1.06 (0.98 – 1.15)
*including frozen cycles. FU: follow-up. RR: relative risk, CI: confidence interval
Randomisation
• Hysteroscopy followed by IVF (intervention
group)
• Immediate IVF (control group)
Intervention
Office hysteroscopy with instant treatment of
detected pathology
Analysis
• By intention-to-treat principle
• Relative risks (RR) with 95% confidence
intervals (CI)
• Kaplan-Meier survival curves for the time to
ongoing pregnancy resulting in live birth
Outcome
• Ongoing pregnancy resulting in live birth
achieved within 18 months after
randomization
Figure 1: trial profile
• Between May 2011 and August 2013, we
randomly allocated 750 women (figure 1)
• Hysteroscopy revealed intra-uterine
abnormalities in 16% of the women
RESULTS 2/2
Figure 2: kaplan meier curve