Objective: The aim of this study was to investigate the performance oftwo widely used catheters for embryo transfer and evaluate their perfor-mance in terms of visualisation and the rate of difficult transfers.

Design: Prospective randomized study.Materials/Methods: At the time of embryo transfer, couples undergoing

IVF�ICSI cycles were equally randomised to one of two groups: in group 1,the transfer was made using a Cook soft trans catheter and, in group 2 bymeans of a Wallace catheter. Only women aged less than 37 years and withat least two type 1 or 2 embryos were selected for the study; no more thanthree embryos were transferred, all of which were performed under trans-abdominal ultrasound guidance. A record was kept of all difficult transfers,catheter visualisation and the need to use the obturator as scored by theoperator or embryologist. The clinical and evolutive pregnancy rates, aswell as the implantation and evolutive implantation rates, were statisticallyanalysed using the Mann-Whitney U test and multivariate analysis asrequired.

Results: The study involved 200 patients with a mean age of 31.2 � 2.7years, and a mean duration of infertility of 3.2 � 3.5 years after a previousmean number of 1.6 � 1.6 attempts. A total of 591 embryos were trans-ferred (200 type 1, 158 type 2 and 20 type 3), a mean of 2.9 � 0.20 embryosper patient.There were no between-group differences in terms of mean age,the number of attempts, indication for treatment, or the number and qualityof the embryos transferred. The clinical pregnancy rate was 40% (4.5%abortions and 1.5% extrauterine pregnancies); the implantation and evolu-tive implantation rates were respectively 20.9% and 17.5%. An obturatorwas used in 32% of the cases, and the transfer was considered difficult in10%. Ultrasound catheter visualisation was considered good in 75% of thetransfers. There were no differences between group 1 and group 2 in termsof the clinical pregnancy rate (43% vs. 37%), the evolutive pregnancy rate(37% vs. 31%) or the number of clinical abortions and extrauterine preg-nancies (3% and 3% vs. 6% and 0%). Catheterisation visualisation was goodin 82% of the cases in group 2 and 68% of those in group 1 (p �0.002). Nodifferences were found in the use of the obturator or the number of difficulttransfers (31% and 11% in group 1, and 33% and 9% in group 2).

Conclusions: The results of this randomised study of two soft coaxialcatheters used for embryo transfer under ultrasound guidance did not revealany significant differences in pregnancy rates, but visualisation during theprocedure was much better with the Wallace catheter.

Supported by: This project was supported by the Humanitas ScientificComitee.

P-361

Vaginal sildenafil improves ART outcome in a large cohort of patientswith multiple prior ART failures attributed to poor endometrial devel-opment. Jeffrey D. Fisch, G. Sher. Sher Institute for Reproductive Med-icine, Las Vegas, NV; Sher Institute for Reproductive Medicine, and Deptof Ob/Gyn, Univ of Nevada Sch of Medicine, Las Vegas, NV.

Objective: Vaginally administered Sildenafil (SDF), in combination withcontrolled ovarian hyperstimulation, improved uterine artery blood flow andsonographic endometrial appearance in 4 women with repeated IVF failureattributed to inadequate endometrial development. These findings, whileinteresting, were inconclusive due to the low number of patients studied.This follow-up study evaluated the effect of vaginally administered SDF onpeak endometrial thickness and ART outcome in a large cohort of infertilewomen with prior ART failures attributed to a thin endometrial lining.

Design: Retrospective cohort analysis in a private practice setting.Materials/Methods: A cohort of 105 infertile women under age 40, with

normal ovarian reserve and 2 or more consecutive prior IVF failuresattributed to inadequate endometrial development, underwent ART using along GnRHa protocol for pituitary desensitization and recombinant gonad-otropins to promote follicular development. In addition, SDF suppositoriesprepared for us by a local pharmacy, were administered vaginally at a doseof 25mg 4 � /d for 3–10 days. Peak endometrial development was assessedby vaginal ultrasound on the day of hCG administration. Pregnancy andimplantation rates were analyzed based on the response to SDF.

Results: Of 105 patients, 73 (70%) (Group A), attained an endometrialthickness of �9 mm with a trilaminar pattern on the day of hCG adminis-tration, while 32 (30%) (Group B) did not. Implantation and ongoingpregnancy rates were significantly higher for Group A (29% and 45%), thanfor Group B (2% and 0%). Of 11 women in Group B who had embryostransferred in that cycle, only 1 conception occurred, which resulted in a

first trimester miscarriage. Among the patients in Group B, 59% had ahistory of endometritis, compared to 44% in Group A.

Conclusions: Vaginal administration of SDF enhanced endometrial de-velopment in 70% of patients studied and 45% conceived an on-goinggestation. The present data support our previously reported findings andlend credence to the idea that high implantation and on-going pregnancyrates can be achieved in a cohort traditionally given a poor-prognosis forsuccess. However, SDF did not improve endometrial development in allpatients studied, and especially those with a previous history of endometritismay have a decreased response to SDF therapy. Further, randomized con-trolled trials will be needed to objectively validate the effectiveness of SDFon endometrial development.

Supported by: None.

P-362

The safety and efficacy of vaginal micronized progesterone (Crinone�8%) indicated as luteal phase support evaluated in a large prospective,multicenter, multinational study in ART. Brian Kaplan. Project Amer-icas Study Group and Highland Park Fertility Ctr, Highland Park, IL.

Objective: To evaluate the safety and efficacy of vaginal micronizedprogesterone (Crinone� 8%).

Design: Multicenter, multinational, prospective, trial conducted in 32ART centers.

Materials/Methods: Data from 682 patients is presented. GnRHa started7–8 days post ovulation (0.5 mg/d) until down regulation was achieved. Thedose was decreased to 0.25 mg/d thereafter until d/hCG. Patients received150–225 IU of FSH for 5 days. On day 6 the dose was adjusted accordingto the patients response. Serum estradiol (E2) and US were used to monitorpatients response. hCG 10,000 U was administered to trigger ovulation.OPU and IVF/ICSI were performed according to each centers protocol.Transfer was limited to 3 embryos or 2 blastocysts. Luteal phase wassupported with Crinone� 8% administered vaginally daily until pregnancytest or twelve weeks in pregnant patients. Treatment was initiated with oneapplicator (90 mg) the day of oocyte retrieval or the day after. The firstpregnancy test was done on day 14–17 following oocyte retrieval.

Results: Results are expressed in means (�SD) or percentages. 97.1% ofthe patients received hCG (662). The duration of FSH stimulation was 10.1days (�1.9) and the number of ampules utilized was 28.2 (�11.2). Thenumber of follicles �14 mm was 9.4 (�4.3). The total number of oocytesretrieved was 11.1 (�6.4) where 8.3 (�4.8) were MII (ICSI patients only).The number of embryos obtained was 6.0 (�3.7). The mean number ofembryos transferred was 2.5 (�0.8). 83.3% of the patients with one positivepregnancy test reached clinical pregnancy confirmed by US. Only 27patients presented intermenstrual bleeding as adverse event (3.8%). Theimplantation rate (defined as number of sacs at US over number of embryostransferred) was 22.1% (�31.7). The clinical pregnancy rate per cycle, OPUand transfer were 35.2%, 36.5% and 38.6% respectively. Five patients(0.7%) suffered from severe OHSS. The duration of the luteal phase inpregnant and non-pregnant patients was similar 14.9 (�1.8) vs. 14.2 (�4.5)days respectively (NS). Other adverse events reported with known associ-ation with progesterone treatment were breast tenderness 1.3%, somnolence0.4% and depression 0.3%. Adverse events reported associated with vaginaladministration of progesterone were leukorrea 0.8% and vaginal discomfort0.4%.

Conclusions: Single agent therapy with FSH delivered excellent out-comes for all evaluated parameters. The implantation rate obtained withCrinone� 8% is comparable to those obtained with other forms of lutealphase support. Episodes of early bleeding are considered acceptable andalways associated with lack of pregnancy. The pregnancy rate obtained inthis study is higher but comparable to the pregnancy rate reported by SARTfor the year 1999 (30.6% per cycle) where other forms of progesterone werecommonly used. Crinone� 8% is safe and effective, delivering excellentluteal phase support without masking the length of the luteal phase innon-pregnant patients. Very low incidence of local and general side effectsassociated with this route of administration plus acceptable cycle outcomemakes this vaginal progesterone the treatment of choice for luteal phasesupport in ART patients.

Supported by: Serono Inc, Rockland, MA.

FERTILITY & STERILITY� S235