Gilad Karavani1, Assaf Ben-Meir1, Yoel Shufaro1, Jordana H Hyman1, Ariel Revel2. 1. Department of Obstetrics and Gynecology, Hadassah Hebrew University Hospital, Jerusalem, Israel. 2. Infertility and IVF Unit, Beilinson Hospital, Rabin Medical Center, Petah-Tikva, Israel; Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel. Electronic address: arielr2@hadassah.org.il.
Abstract
OBJECTIVE: To compare sonographic visualization and patient pain in conventional transabdominal ultrasound (TAUS) with transvaginal ultrasound (TVUS) sonographic-guided embryo transfer (ET). DESIGN: Prospective, randomized, controlled study. SETTING:Tertiary medical center, in vitro fertilization (IVF) unit. PATIENT(S): One hundred and twenty patients younger than 40 years old scheduled for ET. INTERVENTION(S): Patients (32.9 ± 4.5 years old) undergoing fresh cleavage-stage ET were randomly assigned to the study group (TVUS; n = 60) or control group (TAUS; n = 60). After ET each patient filled out a questionnaire based on a visual analogue scale (VAS) to evaluate pain and discomfort before, during, and after the procedure. The physician assessed the quality of sonographic visualization. The follow-up observation lasted 12 months and included pregnancy rates. MAIN OUTCOME MEASURE(S): Visualization of the uterus and ET location and pain before, during, and after the ET procedure. RESULT(S): Visualization of the uterus and the ET location by the physician was statistically significantly better in the TVUS than in the TAUS group (9.57 vs. 8.42 and 9.58 vs. 8.82, respectively). Pain sensation assessed by a visual analogue scale (VAS) before, during, and after the procedure was statistically significantly lower in the study group compared with the control group (5.45 vs. 1.48, 5.03 vs. 2.42 and 2.97 vs. 1.52). The implantation and live-birth rates did not differ between the two groups (32.9% vs. 23.4%, OR 1.61; 95% CI, 0.85-3.07; 31.6% vs. 25.0%, OR 1.39; 95% CI, 0.63-3.09, respectively). CONCLUSION(S): TVUS guidance to facilitate ET is superior to TAUS in visualization of ET location and in lessening the pain and discomfort of the patients. CLINICAL TRIAL REGISTRATION NUMBER: NCT008263312.
RCT Entities:
OBJECTIVE: To compare sonographic visualization and patientpain in conventional transabdominal ultrasound (TAUS) with transvaginal ultrasound (TVUS) sonographic-guided embryo transfer (ET). DESIGN: Prospective, randomized, controlled study. SETTING: Tertiary medical center, in vitro fertilization (IVF) unit. PATIENT(S): One hundred and twenty patients younger than 40 years old scheduled for ET. INTERVENTION(S): Patients (32.9 ± 4.5 years old) undergoing fresh cleavage-stage ET were randomly assigned to the study group (TVUS; n = 60) or control group (TAUS; n = 60). After ET each patient filled out a questionnaire based on a visual analogue scale (VAS) to evaluate pain and discomfort before, during, and after the procedure. The physician assessed the quality of sonographic visualization. The follow-up observation lasted 12 months and included pregnancy rates. MAIN OUTCOME MEASURE(S): Visualization of the uterus and ET location and pain before, during, and after the ET procedure. RESULT(S): Visualization of the uterus and the ET location by the physician was statistically significantly better in the TVUS than in the TAUS group (9.57 vs. 8.42 and 9.58 vs. 8.82, respectively). Pain sensation assessed by a visual analogue scale (VAS) before, during, and after the procedure was statistically significantly lower in the study group compared with the control group (5.45 vs. 1.48, 5.03 vs. 2.42 and 2.97 vs. 1.52). The implantation and live-birth rates did not differ between the two groups (32.9% vs. 23.4%, OR 1.61; 95% CI, 0.85-3.07; 31.6% vs. 25.0%, OR 1.39; 95% CI, 0.63-3.09, respectively). CONCLUSION(S): TVUS guidance to facilitate ET is superior to TAUS in visualization of ET location and in lessening the pain and discomfort of the patients. CLINICAL TRIAL REGISTRATION NUMBER: NCT008263312.