Effect of using an echogenic catheter for ultrasound-guided embryo transfer in an IVF programme: a prospective, randomized, controlled study

BACKGROUND: Recent evidence showed that ultrasound-guided embryo transfer significantly increases successful implantation compared to the clinical touch method. It has been postulated that new echodense catheters which are more readily detectable by ultrasound may refine transfer techniques even more, thus improving IVF outcome. METHODS: A prospective, randomized, controlled trial comparing IVF outcome for women undergoing embryo transfer under ultrasound guidance by a single healthcare provider with random assignment according to a computer-generated randomization table to either standard soft Wallace catheter (standard catheter group, n=95) or the new echogenic soft Wallace catheter (echogenic catheter group, n=98). RESULTS: The use of the echodense catheter facilitated catheter identification under ultrasound, and thus the duration of the embryo transfer procedure since the loaded catheter was handed to the physician and up to embryo discharge was significantly shorter in the echogenic catheter group as compared with the standard catheter group. There were 39 and 53 clinical pregnancies in the standard catheter (41%) and echogenic catheter (54.1%) groups, respectively. This was not statistically significant (P=0.08) according to the OR (0.6) and CIs (0.33-1.04). However, twin pregnancy rate was significantly increased (P<0.01) with the use of the new catheter which was the underlying source for obtaining significant increase in implantation rate in this group (37.1%) as compared with the standard catheter group (23.2%). CONCLUSION: This pilot study suggests that the use of the echogenic Wallace catheter simplifies ultrasound-guided embryo transfer but not definite benefit in terms of pregnancy rates was obtained. In contrast, the use of the new catheter was associated with a significant increase in the number of twin pregnancies.     

Best site for embryo transfer: the upper or lower half of endometrial cavity?

BACKGROUND: The objective of the present study was to determine the importance of the site of embryo transfer (upper or lower half endometrial cavity) on implantation and clinical pregnancy rates. METHODS: A total of 400 transfers guided by ultrasound were randomly assigned to two groups according to the distance between the uterine fundus and the catheter tip at the time of embryo placement. Group I (n = 200) consisted of transfers corresponding to a distance of < 50% of the endometrial cavity length (ECL), i.e. transfer in upper half of the cavity; and group II (n = 200) consisted of transfers corresponding to a distance of > or = 50%, of the ECL, i.e. transfer in lower half of cavity. The Student's t-test, Mann-Whitney test and Fisher's exact test were used where appropriate. RESULTS: The general characteristics of the study population and the main transfer cycle characteristics had an equal distribution (P > 0.05) between groups I and II. No significant difference in implantation or pregnancy rates was observed between groups I and II. CONCLUSION: The implantation or pregnancy rates were similar whether the embryos were deposited in the upper or lower half of the endometrial cavity.     

Soft versus firm embryo transfer catheters for assisted reproduction: a systematic review and meta-analysis

BACKGROUND: The true impact of the embryo transfer catheter choice on an IVF programme has not been fully examined. We therefore decided to systematically review the evidence provided in the literature so that we may evaluate a single variable in relation to a successful transfer, the firmness of the embryo transfer catheter. METHODS: An extensive computerized search was conducted for all relevant articles published as full text, or abstracts, and critically appraised. In addition, a hand search was undertaken to locate any further trials. RESULTS: A total of 23 randomized controlled trials (RCT) evaluating the types of embryo transfer catheters were identified. Only ten of these trials, including 4141 embryo transfers, compared soft versus firm embryo catheters. Pooling of the results demonstrated a statistically significantly increased chance of clinical pregnancy following embryo transfer using the soft (643/2109) versus firm (488/2032) catheters [P = 0.01; odds ratio (OR) = 1.39, 95% confidence interval (CI) = 1.08-1.79]. When only the truly RCT were analysed, the results were again still in favour of using the soft embryo transfer catheters [soft (432/1403) versus firm (330/1402)], but with a greater significance (P < 0.00001; OR = 1.49, 95% CI = 1.26-1.77). CONCLUSION: Using soft embryo transfer catheters for embryo transfer results in a significantly higher pregnancy rate as compared to firm catheters.     

Embryo transfer: ultrasound-guided versus clinical touch.

In this prospective control study, the pregnancy and implantation rates were compared between ultrasound-guided and clinical touch uterine embryo transfers. In addition, a subset of patients was sought that would particularly benefit from embryo transfer under ultrasound guidance. A total of 187 patients (93 ultrasound and 94 clinical touch) was enrolled. Allocation was random and depended on whether their embryo transfers were done during the 1 h each day in which the ultrasound was available. Pregnancy and implantation rates of 37.8 and 20.4% respectively were achieved when ultrasound was used, compared with 28.9 and 16.2% respectively with clinical touch. This difference was not statistically significant. There was no significant difference in the pregnancy rate when the number of embryos transferred was controlled. Older women (>/=37 years old) had an apparently higher pregnancy rate (38.1 versus 20.4%; not significant) with ultrasound guidance during embryo transfer. In the subgroup where the clinician rated the transfer procedure as difficult, there appeared to be a substantial improvement in the pregnancy rate in the group that used ultrasound (54.5 versus 10.0%; not significant). Although our results were not statistically significant, we believe that ultrasound-guided embryo transfers should be used in clinically difficult embryo transfers and in older women, as it appears to improve the pregnancy rate over clinical touch transfers.     

Ultrasound-guided soft catheter embryo transfers will improve pregnancy rates in in-vitro fertilization

Attempts to improve clinical pregnancy rates after in-vitro fertilization (IVF) and embryo transfer are constantly being made. Two changes in technique of embryo transfer of potential clinical importance were evaluated over two contiguous time periods in order to observe any corresponding change in clinical pregnancy (CP) rate per transfer: (i) embryo transfer catheter; (ii) ultrasound guidance. Catheter choices were hard: Tefcat, Tom Cat, or Norfolk; or soft: Frydman or Wallace. Ultrasound visualization was considered to be excellent/good when the catheter could be followed from the cervix to the fundus by transabdominal ultrasound with retention of the embryo-containing fluid droplet; fair/poor if visualization could not document the sequence of events. Embryo transfers were performed in 518 cycles. CP rates per transfer using soft and hard catheters was 36 and 17% (P < 0.000) respectively. CP rates per transfer for transfers performed with and without ultrasound guidance were 38 and 25% (P < 0.002) respectively. A statistically significant difference was also noted when visualization ranks were compared. CP rates per transfer in all excellent/good ultrasound-guided transfers was 41.5 versus 16.7% for fair/poor transfers (P < 0.038). In conclusion, performance of embryo transfer with a soft catheter under ultrasound guidance with good visualization resulted in a significant increase in clinical pregnancy rates.     

Ultrasound-guided embryo transfer improves pregnancy rates and increases the frequency of easy transfers

BACKGROUND: Recent reports have suggested that ultrasound (US) guidance during embryo transfer might improve pregnancy rates. METHODS: A prospective randomized (computer-generated random table) trial was performed to compare embryo transfer under abdominal US guidance (n = 255 women) with clinical touch embryo transfer (n = 260). RESULTS: The clinical pregnancy rate was 26.3% (67/255) in the US-guided transfer group compared with 18.1% (47/260) in the clinical touch transfer group (P < 0.05). The implantation rate was 11.1% (100/903) in the US group compared with 7.5% (66/884) in the clinical touch group (P < 0.05). US-guided transfer was associated with a decrease in the difficulty of the transfers: 97% of transfers were easy in the US-guided group compared with 81% in the clinical touch group (P < 0.05). CONCLUSIONS: US-guided embryo transfer increased pregnancy and implantation rates in IVF cycles, as well as the frequency of easy transfers. It is suggested that the decrease in cervical and uterine trauma can play a role in the increase in pregnancy rates associated with US-guided transfer. It is recommended that embryo transfer should be performed under US guidance.     

Number of embryos for transfer after IVF and ICSI: a Cochrane review

BACKGROUND: The most common complication of IVF is multiple pregnancy, which occurs in 25% of pregnancies following the transfer of two embryos. Single embryo transfer can minimize twin pregnancies but could also lower live birth rates. Our aim was to perform a systematic review of randomized trials to determine the effectiveness of single versus double embryo transfer. METHODS: Cochrane Collaboration review methods were followed. Randomized controlled trials comparing single and double embryo transfers were identified by searching Medline, EMBASE and the Cochrane register of controlled trials. Contents of specialist journals and proceedings from meetings of relevant societies were hand searched. Data were pooled with Rev Man software using the Peto-modified Mantel-Hanzel method. RESULTS: Pooled results from four trials indicate that although double embryo transfer leads to a higher live birth rate per woman [odds ratio (OR) 1.94, 95% confidence interval (CI) 1.47-2.55] in a fresh IVF cycle, comparable results are obtained by subsequent transfer of a frozen embryo (OR 1.19, 95% CI 0.87-1.62). The multiple pregnancy rate is significantly higher (OR 62.83, 95% CI 8.52-463.57) after double embryo transfer. CONCLUSIONS: Single embryo transfer significantly reduces the risk of multiple pregnancy, but also decreases the chance of live birth in a fresh IVF cycle. Subsequent replacement of a single frozen embryo achieves a live birth rate comparable with double embryo transfer.     

Blastocyst Transfer Ameliorates Live Birth Rate Compared with Cleavage-Stage Embryos Transfer in Fresh In Vitro Fertilization or Intracytoplasmic Sperm Injection Cycles: Reviews and Meta-Analysis

Purpose

Blastocyst transfer has been recommended to raise the implantation rate without affecting the pregnancy rate. The objective of this meta-analysis is to systematically evaluate whether the live birth rate and other pregnancy outcomes can be improved by blastocyst transfer compared with cleavage-stage embryos transfer.

Materials and Methods

EMBASE and MEDLINE databases were searched for papers published between March 2004 and March 2013. An extensive range of the electronic databases yielded initially 317 studies from which seven trials met the inclusion criteria for further analysis. Our outcome measures were the live birth rate, clinical pregnancy rate, implantation rate, ongoing pregnancy rate, multiple pregnancy rate, first trimester miscarriage rate and ectopic pregnancy rate. Fixed effects models were chosen to calculate the odds ratio (OR).

Results

Seven trials (n=1446 cases) were finally analyzed. Compared with cleavage-stage embryos transfer, the blastocyst transfer was statistically significantly associated with an increase in clinical pregnancy rate [OR 1.43; 95% confidence interval (CI), 1.15-1.78], implantation rate (OR 1.38; 95% CI, 1.09-1.74) and ongoing pregnancy rate (OR 2.15; 95% CI, 1.57-2.94), and also a reduction in the probability of first trimester miscarriage rate (OR 0.51; 95% CI, 0.30-0.87). The improvement in the live birth rate was also observed (OR 1.77; 95% CI, 1.32-2.37). Moreover, there was no evidence of difference in multiple pregnancy and ectopic pregnancy rates.

Conclusion

The available evidences suggest that live birth and other pregnancy outcomes after fresh in vitro fertilization or intracytoplasmic sperm injection (IVF/ICSI) are significantly improved following blastocyst transfer as compared to cleavage-stage embryo transfer.     

Minimizing embryo expulsion after embryo transfer: a randomized controlled study

BACKGROUND: The aim of this work was to modify the embryo transfer technique to prevent expulsion of the embryos by exerting gentle mechanical pressure on the cervix using the vaginal speculum. METHODS: A total of 639 infertile patients undergoing ICSI were prospectively randomized into two groups using sealed dark envelopes. In the study group (n=325) the screw of the vaginal speculum was loosened in order to exert a gentle pressure on the portiovaginalis of the cervix before ejecting the embryos, and was maintained for 7 min afterwards. In the control group (n=314) no pressure was applied on the cervix during embryo transfer and the vaginal speculum was removed after transferring the embryos. RESULTS: The clinical pregnancy rate was significantly higher in the study group than in the control group [207/325 (67%) versus 150/314 (47.8%); odds ratio (OR) 1.39; 95% confidence interval (CI) 1.11-1.74]. The implantation rate was also significantly higher in the study group [304/913 (33.3%) versus 198/920 (21.5%); OR 1.54; 95% CI 1.26-1.89]. CONCLUSIONS: Applying gentle mechanical pressure on the portiovaginalis of the cervix using the vaginal speculum during and after transferring the embryos significantly improved clinical pregnancy and implantation rates.     

Ultrasound-guided embryo transfer: a prospective randomized controlled trial.

BACKGROUND: Recent reports suggested that ultrasound guidance during embryo transfer might improve the pregnancy rate. METHODS: A prospective randomized controlled trial was performed to compare embryo transfer under ultrasound guidance versus the clinical touch method. A total of 800 embryo transfers was studied; 400 were randomized to ultrasound-guided transfers and 400 were randomized to the clinical touch group. Of these, 441 were fresh cycles and 359 were frozen-thawed cycles. RESULTS: The clinical pregnancy rate was 26.0% in the ultrasound-guided group and 22.5% in the clinical touch group; the difference was not statistically significant. The ongoing pregnancy rate was 23.5% in the ultrasound-guided group compared with 19.0% in the clinical touch group and the difference was again not statistically significant. The implantation rate was slightly higher in the ultrasound-guided group (15.3%) than the clinical touch group (12.0%) (P = 0.048). There were no differences in the incidences of ectopic pregnancy, miscarriage and multiple pregnancy between the two groups. CONCLUSIONS: A significant improvement in implantation rate was observed following the use of ultrasound guidance during embryo transfer. The extent of improvement in the pregnancy rate may depend on the specific techniques and methods of embryo transfer used in individual centres.     

A randomized controlled trial of a soft double lumen embryo transfer catheter versus a firm single lumen catheter: significant improvements in pregnancy rates

BACKGROUND: Embryo transfer has changed little since originally described in 1978. Clinicians rate the type of catheter used as the third most important variable in embryo transfer, but there are no adequately powered randomized trials. We compared the clinical pregnancy rates with the single lumen catheter (TCC) and the double lumen catheter (CC) in a randomized single blind trial. METHODS: A total of 650 cycles of women from the Adelaide University reproductive medicine units in Australia were included in this trial. Patients were <40 years of age undertaking IVF and embryo transfer. Exclusion criteria were: known uterine abnormality, day 3 FSH >10 IU/l, previous difficult embryo transfer and pre-implantation genetic diagnosis. Cycles were randomized from numbered sealed envelopes immediately prior to embryo transfer with stratification for fresh or frozen cycles. RESULTS: There was a significantly higher pregnancy rate in the group treated with the CC compared with the TCC catheter [29.6 versus 20.5% per embryo transfer, odds ratio (OR) = 1.63 (95% confidence interval: 1.14-2.30), P = 0.0076]. The point estimate for the OR was similar for fresh and frozen cycles. CONCLUSIONS: The pregnancy rate was increased by 50% and this justifies the increased cost of the soft double lumen catheter and the training of clinical staff required.     

A randomized controlled trial of prophylactic antibiotics (co-amoxiclav) prior to embryo transfer

BACKGROUND: Bacterial contamination of the transfer catheter during embryo transfer is associated with poor clinical outcomes. Antibiotics at the time of embryo transfer may improve outcomes. We evaluated the effect of co-amoxiclav on the rates of bacterial contamination of transfer catheters and clinical pregnancy. METHODS: On the day of oocyte collection, 350 patients were randomized, with sequentially numbered opaque-sealed envelopes containing treatment allocation assigned randomly by computer, to receive co-amoxiclav on the day before and the day of embryo transfer, or no antibiotics. Following transfer, the catheter tips were cultured and assessed to identify the organism(s) isolated and to quantify the level of the contamination. Couples were followed for 8 weeks to determine whether they had achieved clinical pregnancy. Outcome assessors were blinded to the treatment allocation, and the analysis was by intention to treat. RESULTS: Antibiotics significantly reduced catheter contamination rates (49.4 versus 62.3%, RR = 0.79, 95% CI: 0.64, 0.97, P = 0.03). There was no difference detected in clinical pregnancy rates between the two groups (36.0 versus 35.5%, P = 0.83) although there was a significant (P = 0.03) association between the level of bacterial contamination and clinical pregnancy rates. CONCLUSIONS: Co-amoxiclav reduces catheter contamination, but this is not translated into better clinically relevant outcomes such as clinical pregnancy rates. Our findings do not support the routine use of antibiotics at embryo transfer.     

Live birth rates after transfer of equal number of blastocysts or cleavage-stage embryos in IVF. A systematic review and meta-analysis

BACKGROUND: Both cleavage-stage and blastocyst-stage embryo transfer policies have advantages and drawbacks. The number of embryos transferred, however, is a crucial parameter that needs to be considered before attempting any comparison. METHODS: An extensive literature search yielded initially 282 studies from which 8 randomized controlled trials met the inclusion criteria: (i) truly randomized design (ii) policy to transfer equal number of embryos in both the cleavage-stage and the blastocyst-stage groups and (iii) published as full text in a peer-review journal. Primary outcome was the live birth rate and secondary outcomes were clinical pregnancy rate, multiple pregnancy rate, cancellation rate and cryopreservation rate. RESULTS: A total of 1654 patients were reviewed. Live birth rate per randomized patient was significantly higher (n = 6 studies) in patients who had a blastocyst-stage transfer as compared to patients with cleavage-stage embryo transfer [odds ratio (OR): 1.39, 95% confidence interval (CI): 1.10-1.76; P = 0.005]. Clinical pregnancy rate (OR: 1.27, 95% CI: 1.03-1.55; P = 0.02) and cancellation rate per patient randomized (OR: 2.21, 95% CI: 1.47-3.32; P = 0.0001) were significantly higher in patients with a blastocyst-stage embryo transfer as compared to patients in whom a cleavage-stage embryo transfer was performed. The cryopreservation rate was significantly higher in the cleavage-stage group (OR: 0.28, 95% CI: 0.14-0.55; P = 0.0002). CONCLUSIONS: The best available evidence suggests that the probability of live birth after fresh IVF is significantly higher after blastocyst-stage embryo transfer as compared to cleavage-stage embryo transfer when equal number of embryos are transferred in the two groups compared.     

Influence of the time interval between embryo catheter loading and discharging on the success of IVF

BACKGROUND: To ascertain the influence of the duration of the 'interval loading-discharging embryos' (ILDE) on the results of embryo transfer. METHODS: The population under study consisted of 450 consecutive fresh embryo transfers. ILDE was measured in all transfers. Pregnancy and implantation rates were analyzed. RESULTS: Conceptional cycles had a lower (mean +/- SD) ILDE than non conceptional cycles (53.5 +/- 43.6 s vs 63.7 +/- 49.3). When only easy transfers--defined as those not requiring cervical tenaculum--were considered, similar differences were observed. The following pregnancy rates were obtained according ILDE duration: 38.9% (ILDE < 30 s), 33.2% (ILDE 31-60), 31.6% (ILDE 61-120) and 19.1% (ILDE > 120) (P < 0.05). When only easy transfers were considered, similar results were obtained: 40.0%, 33.3%, 32.0% and 19.4%, respectively. Similar results were observed regarding implantation rates regarding the whole population (21.2%, 15.4%, 15.9% and 9.4%, respectively; P < 0.01) as well as when only easy transfers were considered. CONCLUSIONS: ILDE duration is a prognostic factor of pregnancy rate and of implantation rate in IVF. The longer the ILDE duration, the lower the pregnancy and implantation rates. The decrease in pregnancy and implantation rates is gradual until an ILDE of 120 s, and decreases sharply afterwards. It is recommended to speed up the embryo transfer process, wherever possible. ILDE > 120 s carries a poor prognosis and should, when possible, be avoided.     

A prospective randomized study to assess the benefit of partial zona pellucida digestion before frozen-thawed embryo transfers

BACKGROUND: Assisted hatching (AH) in fresh embryo transfer (ET) could be associated with increased implantation rates. However, very few prospective randomized studies have specifically addressed the issue of AH during frozen-thawed embryo transfers (FET) cycles, those that have reported controversial results. The aim of this study was to evaluate the benefit of an enzymatic zona pellucida treatment of frozen-thawed embryos before transfer. METHODS: This was a prospective study including 125 non-donor FET cycles from 125 infertile couples. FETs were randomly allocated into AH group (n = 61, embryos pretreated with pronase 5 IU/ml for 1 min at 37 degrees C) or control group (n = 64, untreated embryos). Zona pellucida thickness was measured for each transferred embryo. The main outcome parameters were clinical pregnancy and implantation rates. RESULTS: The two groups were comparable regarding mean women's age, duration and indications of infertility, IVF outcome after fresh ETs, numbers and quality of fresh and frozen embryos, frozen-thawed embryo survival rates and blastomeres survival indexes. Despite a statistically significant decrease of zona pellucida thickness after pronase treatment [(mean +/- SD) 18.5 +/- 2.25 versus 14.5 +/- 2.75 microm; P < 0.0001], implantation (9.6 versus 9.2%) and clinical pregnancy rates (18.0 versus 17.2%) were not statistically different after FETs, with a similar mean number of embryos transferred between AH and control groups, respectively. CONCLUSION: Within the constraints of our protocol, partial enzymatic digestion of zona pellucida by pronase was not related with any benefit of the FET outcome especially concerning the implantation ability of frozen-thawed embryos.     

Transvaginal ultrasound-guided embryo transfer improves pregnancy and implantation rates after IVF.

BACKGROUND: Attempts are constantly being made to improve clinical pregnancy rates after IVF and embryo transfer. Since November 1998, we have gradually been adopting transvaginal ultrasound guidance during embryo transfer. We retrospectively examined the efficacy of this method on pregnancy and implantation rates. METHODS: The results of 846 cycles from our IVF-embryo transfer programme were analysed and comparisons were made between those carried out using ultrasound guidance and those by the clinical touch method. RESULTS: Higher pregnancy and implantation rates (28.9 and 15.2% respectively) were found in the group using the transvaginal ultrasound guidance during embryo transfer compared with those in the group using the clinical touch method (13.1 and 7.0% respectively). The differences were statistically significant (P < 0.01). There was no significant difference in ectopic pregnancy rates between the two groups. CONCLUSION: The use of transvaginal ultrasound-guided embryo transfer significantly improved both pregnancy and implantation rates. Although technically difficult, we suggest its use may maximize the chances of achieving a successful pregnancy outcome.     

Does the choice of catheter for embryo transfer influence the success rate of in-vitro fertilization?

The performance of two different transfer catheters has been evaluated in 193 consecutive embryo transfers. Forty pregnancies were achieved, corresponding to a pregnancy rate of 21% of all embryo transfers. The Frydman catheter was used in 123 attempts whereas 70 embryo transfers were performed with the Tom Cat catheter. The Tom Cat catheter yielded a significantly higher pregnancy rate than the Frydman catheter (28% versus 16%; P = 0.03). The mean number of embryos transferred per attempt was similar in the two groups (2.9 +/- 0.1 and 3.0 +/- 0.1 in the Tom Cat and Frydman groups respectively) as was the quality. When more than three embryos were transferred, a pregnancy rate of 37% per embryo transfer was achieved using the Tom Cat versus 20% using the Frydman catheters (P = 0.03). A higher frequency of difficult transfer procedures was observed when the Frydman catheter was used while the Tom Cat performed much better in difficult cases. An alternate use of the two catheters suggests a significantly better performance of the Tom Cat catheter in relation to the efficiency of establishing pregnancy.     

Ultrasound-guided embryo transfer maximizes the IVF results on day 3 and day 4 embryo transfer but has no impact on day 5

BACKGROUND: The use of ultrasound-guided embryo transfer has been reported to affect success rates in some centres but not others. In a prospective study, we examined the influence of ultrasound guidance in embryo transfer performed on different days after oocyte retrieval. METHODS: Two different methods of embryo transfer were evaluated in 1069 consecutive transfers. The ultrasound-guided embryo transfer was used in 433 cases, whereas 636 embryo transfers were performed with the tactile assessment ('clinical feel') method. RESULTS: Ultrasound-guided embryo transfer yielded a higher overall pregnancy rate than the 'clinical feel' approach, 47 versus 36% (P < 0.001). This difference was statistically significant where embryos were transferred after 3 or 4 days of culture, 45.9 versus 37.1% (P = 0.001) and 42.3 versus 27% (P = 0.035) respectively but not significant (P = 0.112) on day 5 embryo transfer (56.3 versus 45.7%). Likewise, the implantation rate was significantly different between the two groups on day 3 and 4 embryo transfer, 23.3 versus 15.8% (P < 0.01) and 21.6 versus 15.7% (P < 0.05%) respectively but no statistical difference was noted on day 5 embryo transfer, 26.7 versus 23.6%. CONCLUSION: Ultrasound assistance in embryo transfer on day 3 and 4 significantly improved pregnancy rates in IVF but had no impact on day 5.     

Ultrasound-guided embryo transfer does not offer any benefit in clinical outcome: a randomized controlled trial

BACKGROUND: Ultrasound-guided embryo transfer (ET) is widely suggested as a standard clinical practice that improves overall embryo implantation and pregnancy rates. Various studies of this issue suffer from methodological pitfalls, so that a randomized controlled trial, which overcomes these problems, might be valuable. METHODS: Three hundred women aged <40, who underwent fresh ET, were included in this randomized, double-blind controlled trial. The K-J-SPPE echo tip soft catheter was used for the ultrasound-guided ET and the traditional K-Soft catheter for ETs not using ultrasound. One experienced operator performed all ETs. The primary study outcome was overall pregnancy rate (defined as the number of positive hCG results per transfer). RESULTS: No significant differences between groups were found regarding baseline patient and embryological characteristics, except for male factor and unexplained infertility (higher in the blind and ultrasound-guided ET group, respectively, P < 0.05). Overall pregnancy rates were 53.3 and 51.3% in the ultrasound-guided and blind ET group, respectively. Two ectopic pregnancies were reported in each group. Difficulty in cervical negotiation did not differ between the two groups. CONCLUSIONS: In patients undergoing ET by an experienced operator, ultrasound guidance did not provide any benefit in terms of overall clinical pregnancy and embryo implantation rates.