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Predictors of fibroid tumor recurrence after myomectomy
P-565 Efficacy and ease of use of a new liquid formulation of recombinant human chorionic gonadotropin (r-hCG) utilized for final follicle maturation in an ovum donation (OD) program. M. Gill, J. Marchetti, J. Martinez, Z. Rosenwaks. The Center for Reproductive Medicine and Infertility, New York, NY. OBJECTIVE: Our ovum donation team is constantly looking for innovations regarding protocols, techniques or drugs that could simplify controlled ovarian hyperstimulation (COH) without compromising cycle outcomes. In November 2003 a new liquid formulation of r-hCG in a pre-filled syringe was introduced. After evaluating the equivalency studies between the liquid and freeze dried formulations, we decided to use the new formulation for the induction of final follicle maturation in the entire donor population from January 1st ⫺ March 26 th 2004. The objective of this study was to evaluate the efficacy and ease of use of a new liquid formulation of r-hCG. DESIGN: Prospective, noncomparative, observational study. MATERIALS AND METHODS: 26 donors and 42 recipients were included in the study. After achieving downregulation with leuprolide acetate, donors started a standard COH protocol on day 3 of menses using recombinant human FSH (r-hFSH). When at least two follicles reached a mean diameter ⬎17mm, r-hCG 250 mcg was administered subcutaneously (SC) to achieve final follicular maturation. Ovum harvest was scheduled 36 hours after r-hCG injection. Oocytes were fertilized by intracytoplasmic sperm injection (ICSI) and the embryos produced were transferred 3 or 5 days after retrieval. Donors received written and verbal instructions for self administering the r-hCG. A short survey consisting of three questions was given to the donors to assess ease of use (very easy, easy, difficult) and injection tolerability (nothing, pain, itching, burning) of liquid r-hCG. Additionally, donors were asked to evaluate how confident (very, somewhat, not) they were that the full hCG dose was injected. Donors were also invited to write in comments. Statistics were summarized using JMP 5.0, SAS Institute. RESULTS: Mean age for donors was 27.4 ⫾ 3.3 years; body mass index 22.6 ⫾ 3.0 kg/m2; total r-hFSH utilized 1731 ⫾ 490 IU; peak estradiol1509.9 ⫾ 599.0 pg/mL; number of oocytes retrieved 12.6 ⫾ 4.6; metaphase 2 (M2) oocytes 9.6 ⫾ 3.6; oocytes/M2 ratio 76%; oocytes fertilized 8.9 ⫾ 3.2; M2/fertilized ratio 93%; embryos frozen 1.4 ⫾ 1.7; and oocytes to recipient 13.1 ⫾ 4.7. No cycles were cancelled. Recipients with embryo transfer (n⫽41) with a mean age 42.5 ⫾ 4.1, received 2.0 ⫾ 0.5 embryos transferred on day 3.4 ⫾ 0.8. The clinical pregnancy rate (gestational sacs on ultrasound) was 53.7% (22/41). All donors completed the survey and 100% evaluated the injection as very easy and also felt very confident that they injected the full dose. 25 (96.1%) felt nothing after injection and one donor reported itching. Prior donors who had participated in our program were thrilled to have a ready-to-use, liquid pre-filled syringe for SC injection instead of an intramuscular injection. CONCLUSION: To our knowledge, this is the first report on the routine clinical use of the new liquid formulation of r-hCG. Although this was a small, uncontrolled study, the new formulation of r-hCG was effective and user-friendly which is ideal for our donor population, and no adverse events were observed. An adequately powered, randomized, prospective study is needed to confirm our results. Supported by: Serono, Inc.
REPRODUCTIVE SURGERY P-566 Predictors of fibroid tumor recurrence after myomectomy. M. Hanafi. Saint Joseph’s Hospital of Atlanta, Atlanta, GA. OBJECTIVE: The purpose of this study was to evaluate the factors associated with the recurrence of leiomyomata after myomectomy. DESIGN: Retrospective clinical study of 145 consecutive cases of abdominal myomectomy performed by a single surgeon. MATERIALS AND METHODS: Fibroid recurrence, diagnosed by transvaginal ultrasound, was evaluated by life table analysis, log-rank tests, and Wilcoxon rank-sum tests according to clinical characteristics of patients.
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The following factors were considered: uterine size at time of surgery, number of fibroids removed, concurrent adenomyosis, patient age, patient body mass index, and subsequent parity. RESULTS: The 48-month cumulative recurrence rate was significantly lower in patients with a single myoma removed (41%), compared with patients with multiple myomas (56%; P⫽.031). The median intervals from surgery to recurrence were 33 months and 35 months, respectively (P⫽.982). Patients with childbirth after myomectomy also had a significantly lower cumulative recurrence rate at 48 months (0%), versus patients without subsequent childbirth (66%; P⫽.007). The median duration of time before recurrence was 56 months in the former group, compared with 32 months in the latter group (P⫽.022). Patient age appeared to have a strong relationship with recurrence; the 48-month cumulative recurrence rate was 35% in patients younger than 35 years, compared with 75% in patients over 39 years (P⫽.005). The median time to recurrence was 45 months in the younger group, and 21 months in the older group (P⫽.015). However, there was a strong association between age group and subsequent parity (P⫽.001) that may have affected these results. The results were similar whether the evaluation of recurrence included all fibroids visible on ultrasound, or if it was limited to tumors of at least 2 cm in diameter. Very few patients had subsequent surgery during the follow up period, and no statistically significant differences in surgery rates were detected according to the prognostic variables. CONCLUSION: Subsequent parity, solitary myomectomy, and younger patient age were all associated with lower rates of fibroid recurrence after myomectomy. Supported by: None.
P-567 Effect of time to surgery on the outcome of subsequent IVF cycles in endometriosis patients. M. A. Bedaiwy, T. Falcone, E. Katz, J. Noriega, R. Assad, J. Thornton. Assuit University, Assuit, Egypt; Cleveland Clinic Foundation, Cleveland, OH. OBJECTIVE: It is generally accepted that pregnancy rates with IVF in patients with endometriosis are less than expected. It is unclear whether surgical removal prior to IVF will improve pregnancy rates. The objective of this study was to evaluate the effect of time from surgery on the outcome of subsequent IVF cycles in endometriosis patients. DESIGN: Retrospective study. MATERIALS AND METHODS: One hundred and five women treated surgically for endometriosis that underwent 252 IVF cycles between 1994 and 2003 were included. Approximately 1⁄2, 1⁄4 and 1/5 of the study group underwent 1,2 and 3 cycles respectively. We used the cycle as the basic unit of analysis with the time since surgery as the independent variable and the clinical pregnancy as the dependant variable. We used non-parametric approach for estimating the probabilities. To convey the uncertainty of the probability estimates, we produced bootstrap 95% CI. RESULTS: The overall pregnancy rate was 31%. The estimated probability of clinical pregnancy along with bootstrap 95-CI was shown in the table. The estimate is weighted average of nearby points and the CI was based on 1000 bootstrap interactions. CONCLUSION: There does not appear to be any relationship between the length of time from surgery and clinical outcome. Because our sample included so few cycles taking place more than five years after surgery, there is a great deal of uncertainty in our estimates of the probability of clinical pregnancy when the time since surgery is more than five years; this is reflected in the large confidence intervals. Therefore, our interpretation will focus on cycles within five years of surgery. The data do not provide evidence for a strong relationship between the time since surgery and the probability of a clinical pregnancy. The point estimates suggest that there may be a slight negative relationship, since the estimated probability decreases steadily from .34 to .21 as the time since surgery goes from .5 to 5 years. However, the confidence intervals for these probabilities overlap substantially, and we cannot rule out the possibility that the apparent decline is due to chance variation. Supported by: None
Vol. 82, Suppl. 2, September 2004
REPRODUCTIVE SURGERY P-566 Predictors of fibroid tumor recurrence after myomectomy. M. Hanafi. Saint Joseph’s Hospital of Atlanta, Atlanta, GA. OBJECTIVE: The purpose of this study was to evaluate the factors associated with the recurrence of leiomyomata after myomectomy. DESIGN: Retrospective clinical study of 145 consecutive cases of abdominal myomectomy performed by a single surgeon. MATERIALS AND METHODS: Fibroid recurrence, diagnosed by transvaginal ultrasound, was evaluated by life table analysis, log-rank tests, and Wilcoxon rank-sum tests according to clinical characteristics of patients.
S336
The following factors were considered: uterine size at time of surgery, number of fibroids removed, concurrent adenomyosis, patient age, patient body mass index, and subsequent parity. RESULTS: The 48-month cumulative recurrence rate was significantly lower in patients with a single myoma removed (41%), compared with patients with multiple myomas (56%; P⫽.031). The median intervals from surgery to recurrence were 33 months and 35 months, respectively (P⫽.982). Patients with childbirth after myomectomy also had a significantly lower cumulative recurrence rate at 48 months (0%), versus patients without subsequent childbirth (66%; P⫽.007). The median duration of time before recurrence was 56 months in the former group, compared with 32 months in the latter group (P⫽.022). Patient age appeared to have a strong relationship with recurrence; the 48-month cumulative recurrence rate was 35% in patients younger than 35 years, compared with 75% in patients over 39 years (P⫽.005). The median time to recurrence was 45 months in the younger group, and 21 months in the older group (P⫽.015). However, there was a strong association between age group and subsequent parity (P⫽.001) that may have affected these results. The results were similar whether the evaluation of recurrence included all fibroids visible on ultrasound, or if it was limited to tumors of at least 2 cm in diameter. Very few patients had subsequent surgery during the follow up period, and no statistically significant differences in surgery rates were detected according to the prognostic variables. CONCLUSION: Subsequent parity, solitary myomectomy, and younger patient age were all associated with lower rates of fibroid recurrence after myomectomy. Supported by: None.
P-567 Effect of time to surgery on the outcome of subsequent IVF cycles in endometriosis patients. M. A. Bedaiwy, T. Falcone, E. Katz, J. Noriega, R. Assad, J. Thornton. Assuit University, Assuit, Egypt; Cleveland Clinic Foundation, Cleveland, OH. OBJECTIVE: It is generally accepted that pregnancy rates with IVF in patients with endometriosis are less than expected. It is unclear whether surgical removal prior to IVF will improve pregnancy rates. The objective of this study was to evaluate the effect of time from surgery on the outcome of subsequent IVF cycles in endometriosis patients. DESIGN: Retrospective study. MATERIALS AND METHODS: One hundred and five women treated surgically for endometriosis that underwent 252 IVF cycles between 1994 and 2003 were included. Approximately 1⁄2, 1⁄4 and 1/5 of the study group underwent 1,2 and 3 cycles respectively. We used the cycle as the basic unit of analysis with the time since surgery as the independent variable and the clinical pregnancy as the dependant variable. We used non-parametric approach for estimating the probabilities. To convey the uncertainty of the probability estimates, we produced bootstrap 95% CI. RESULTS: The overall pregnancy rate was 31%. The estimated probability of clinical pregnancy along with bootstrap 95-CI was shown in the table. The estimate is weighted average of nearby points and the CI was based on 1000 bootstrap interactions. CONCLUSION: There does not appear to be any relationship between the length of time from surgery and clinical outcome. Because our sample included so few cycles taking place more than five years after surgery, there is a great deal of uncertainty in our estimates of the probability of clinical pregnancy when the time since surgery is more than five years; this is reflected in the large confidence intervals. Therefore, our interpretation will focus on cycles within five years of surgery. The data do not provide evidence for a strong relationship between the time since surgery and the probability of a clinical pregnancy. The point estimates suggest that there may be a slight negative relationship, since the estimated probability decreases steadily from .34 to .21 as the time since surgery goes from .5 to 5 years. However, the confidence intervals for these probabilities overlap substantially, and we cannot rule out the possibility that the apparent decline is due to chance variation. Supported by: None
Vol. 82, Suppl. 2, September 2004