TY - JOUR

T1 - Endometrial scratch injury with office hysteroscopy before IVF/ICSI

T2 - A randomised controlled trial

AU - Berntsen, Sine

AU - Hare, Kristine Juul

AU - Løssl, Kristine

AU - Bogstad, Jeanette

AU - Palmø, Jan

AU - Prætorius, Lisbeth

AU - Zedeler, Anne

AU - Pinborg, Anja

PY - 2020

Y1 - 2020

N2 - Objective: Endometrial scratch injury (ESI) has been proposed to improve endometrial receptivity and thereby increase implantation rates in assisted reproductive technology (ART) treatment. ESI has been widely incorporated into clinical practice despite inconclusive evidence of its effect on reproductive outcomes. We aimed to assess pregnancy and live birth rates in subfertile women receiving ESI before IVF treatment in comparison to controls. Study design: This was a randomised controlled trial (RCT) with no blinding of participants, investigators or health care personnel. Women in ART treatment were allocated to either office hysteroscopy with ESI (ESI group) or no intervention (control group). In total 184 women in IVF/ICSI treatment with minimum one previous failed IVF/ICSI cycle, were included in the final analysis. The primary outcome was positive serum hCG (s-hCG). Secondary outcomes were ongoing pregnancy and live birth rate. Only per-protocol analyses were performed as all patients included at one centre had to be excluded. The trial is registered at ClinicalTrials.gov, NCT01743391. Results: Our results showed a non-significant increase in positive s-hCG (OR 1.23, 95 % CI (0.65–2.33)), ongoing pregnancy (OR 1.52, 95 % CI (0.73–3.17)), and live birth rates (OR 1.69, 95 % CI (0.78–3.64)) per randomised woman between the ESI and the control group. Conclusion: We observed no significant differences in positive s-hCG or other reproductive outcomes in the ESI vs. the control group. While the crude estimates of positive reproductive outcomes were higher in the ESI group, statistical significance was not reached, and the study was not powered to show smaller differences. However, data from this study will be re-evaluated in the context of an individual participant data meta-analysis (IPD-MA) of RCTs on ESI.

AB - Objective: Endometrial scratch injury (ESI) has been proposed to improve endometrial receptivity and thereby increase implantation rates in assisted reproductive technology (ART) treatment. ESI has been widely incorporated into clinical practice despite inconclusive evidence of its effect on reproductive outcomes. We aimed to assess pregnancy and live birth rates in subfertile women receiving ESI before IVF treatment in comparison to controls. Study design: This was a randomised controlled trial (RCT) with no blinding of participants, investigators or health care personnel. Women in ART treatment were allocated to either office hysteroscopy with ESI (ESI group) or no intervention (control group). In total 184 women in IVF/ICSI treatment with minimum one previous failed IVF/ICSI cycle, were included in the final analysis. The primary outcome was positive serum hCG (s-hCG). Secondary outcomes were ongoing pregnancy and live birth rate. Only per-protocol analyses were performed as all patients included at one centre had to be excluded. The trial is registered at ClinicalTrials.gov, NCT01743391. Results: Our results showed a non-significant increase in positive s-hCG (OR 1.23, 95 % CI (0.65–2.33)), ongoing pregnancy (OR 1.52, 95 % CI (0.73–3.17)), and live birth rates (OR 1.69, 95 % CI (0.78–3.64)) per randomised woman between the ESI and the control group. Conclusion: We observed no significant differences in positive s-hCG or other reproductive outcomes in the ESI vs. the control group. While the crude estimates of positive reproductive outcomes were higher in the ESI group, statistical significance was not reached, and the study was not powered to show smaller differences. However, data from this study will be re-evaluated in the context of an individual participant data meta-analysis (IPD-MA) of RCTs on ESI.

KW - ART

KW - Endometrial scratch injury

KW - Endometrial scratching

KW - IVF

KW - Office hysteroscopy

U2 - 10.1016/j.ejogrb.2020.06.034

DO - 10.1016/j.ejogrb.2020.06.034

M3 - Journal article

C2 - 32593936

AN - SCOPUS:85086788850

VL - 252

SP - 112

EP - 117

JO - European Journal of Obstetrics, Gynecology and Reproductive Biology

JF - European Journal of Obstetrics, Gynecology and Reproductive Biology

SN - 0301-2115

ER -