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Use of recombinant hCG results in reduced IVF pregnancy rates compared to non-recombinant u-hCG
nancies achieved through oocyte donation. A significant number of donors were rejected by the counselor⬘s interview, independent of any testing. Therefore, blood testing alone of oocyte donors represents inadequate screening. Supported by: none.
Tuesday, October 15, 2002 4:00 P.M. O-113 Use of recombinant hCG results in reduced IVF pregnancy rates compared to non-recombinant u-hCG. Matthew G. Retzloff, Katharine V. Jackson, Janis H. Fox, Elizabeth S. Ginsburg, Catherine Racowsky. Ctr for Reproductive Medicine, Dept of Obstetrics, Gynecology and Reproductive Biology, Brigham and Women’s Hosp, Harvard Medical Sch, Boston, MA. Objective: Non-recombinant urinary hCG (u-hCG) has proven efficacy for controlled ovarian stimulation (COS) for purposes of IVF. A recombinant subcutaneous hCG (Ovidrel威) product has been introduced to replace u-hCG with presumed equivalent efficacy. This study was conducted to compare the overall effectiveness of Ovidrel vs. non-recombinant u-hCG (Novarel威, Profasi威, Pregnyl威). Design: Retrospective case-controlled series of IVF cycles utilizing Ovidrel (n ⫽ 112) or u-hCG (n ⫽ 112), performed from May 2001 to March 2002 at Brigham and Women’s Hospital, Boston, MA. Materials/Methods: All patients undergoing IVF between May 2001 and March 2002 were screened to identify those who received Ovidrel (250 mcg) prior to egg retrieval (n ⫽ 157). From this group, 112 patients were identified for whom controls receiving non-recombinant hCG (u-hCG; 10,000 IU IM) were available as matched by date of retrieval, age, attempt number, stimulation protocol, and follicle number. Each of the two hCG groups was compared with regards to time from hCG to retrieval, number of oocytes retrieved, number of mature oocytes (MII), egg:follicle (⬎12mm) ratio, MII:follicle ratio, fertilization rate per MII oocyte, total number embryos produced, mean number of embryos transferred, ongoingdelivered rates per embryo transfer (ET), and implantation rates. Statistical analyses were performed utilizing 2 or Wilcoxon Signed Rank tests where appropriate, with p ⬍0.05 considered statistically significant. Results: The u-hCG and Ovidrel groups did not differ for age (36.2 vs. 36.2y), number of follicles (⬎12mm) (12.8 vs. 12.3), peak estradiol (2091 vs. 2065 pg/ml), time from hCG to retrieval (36.1 vs. 36.1hr), or number of embryos transferred (3.45 vs. 3.39). Within each group, the distribution of patients by stimulation regimen (luteal down-regulation, flare, or GnRH antagonist) did not differ. However, in the Ovidrel group, there was a significant reduction in the egg:follicle ratio, the MII:follicle ratio and the total number of embryos obtained. Furthermore, the ongoing-delivered rate was significantly lower in the Ovidrel group. The relevant results are summarized in the table below
# Pts with ETs Attempt number Total # oocytes Total # MII Egg: Follicle MII: Follicle Total # embryos # Embryos transferred # OG-delivered/ET (%) Impl. rate (FH/#ET)
u-hCG 105
Ovidrel 97
P-value
1.45 ⫾ 0.50 13.2 ⫾ 7.7 10.1 ⫾ 6.0 1.08 ⫾ 0.41 0.835 ⫾ 0.37 7.53 ⫾ 5.27 3.45 ⫾ 1.56 52 (49.5%) 18.6%
1.24 ⫾ 0.43 11.9 ⫾ 6.9 8.9 ⫾ 5.5 0.98 ⫾ 0.33 0.731 ⫾ 0.28 6.37 ⫾ 4.40 3.39 ⫾ 1.54 33 (34.0%) 15.0%
0.003 0.036 NS 0.050 0.025 0.029 NS 0.037 NS
Conclusions: Our results indicate that recombinant hCG is not as effective as non-recombinant hCG for COS in IVF. Recombinant hCG had a negative impact on the total number of oocytes retrieved and the MII:follicle ratio, thereby resulting in a smaller “pool” of embryos from which to select for transfer. The collective effects of these differences led to a significantly higher ongoing-delivered pregnancy rate for non-recombinant preparations of hCG. Based on these data we recommend u-hCG rather than Ovidrel to maximize success in IVF. Supported by: None.
S44
Abstracts
Tuesday, October 15, 2002 4:15 P.M. O-114 Basal antral follicle number predicts IVF cycle pregnancy, cancellation, and ovarian responsiveness: A prospective study. John L. Frattarelli, Andy Levi, Bradley T. Miller, James H. Segars. Tripler Army Medical Ctr, Honolulu, HI; Combined Fed Program for Reproductive Endocrinology, NIH, Bethesda, MD; Reproductive Medicine Assoc of New Jersey, Morristown, NJ. Objective: The functional ovarian reserve as measured by basal antral follicle count has been suggested to predict follicular response in IVF. The objective of this study was to prospectively determine the predictive value and define threshold values for basal antral follicle number in patients undergoing IVF treatment. Design: An prospective analysis of 267 infertility patients at a tertiary care center undergoing ovarian assessment prior to IVF stimulation. Materials/Methods: All women had basal ovarian measurements performed on cycle day 3 prior to starting gonadotropins. Main outcome measures were the number of follicles produced, number of oocytes obtained, and cycle outcomes. To assess ovarian responsiveness, the pretreatment ovarian ultrasound measurements were compared with respect to patient’s age, day 3 estradiol, day 3 FSH, day 3 LH, peak estradiol, ampules of gonadotropins used, and days of stimulation. A linear regression model was used to identify any correlation between two continuous variables. Additional statistical analysis was performed using a one-way Analysis of Variance test, Kruskal-Wallis ANOVA, Wilcoxon-Mann-Whitney test for nonparametric data, t-test for parametric data, and a Chi-square test for trends. An alpha error of 0.05 was considered significant for all calculations. Results: Patients who became pregnant had a significantly greater number of antral follicles (13.8 ⫹/⫺ 7.5 vs. 12.4 ⫹/⫺ 10.0) (p ⬍0.01). Patients whose cycles were cancelled had significantly fewer antral follicles (7.6 ⫹/⫺ 4.8 vs. 13.7 ⫹/⫺ 8.8) (p ⬍0.01). Antral follicle number demonstrated a significant positive linear correlation with number of follicles, recovered oocytes, number of embryos, ovarian volume, day 3 LH, and peak estradiol (p ⬍0.05). A significant negative linear correlation was noted with ampules of gonadotropins used, days of stimulation, patient’s age, and day 3 FSH (p ⬍0.05). Threshold analysis demonstrated a lower pregnancy rate in patients with ⬍5 antral follicles (23.5% vs. 57.6%) (p ⬍0.01). Likewise, threshold analysis revealed a higher cancellation rate associated with ⬍5 antral follicles (41% vs. 6.9%) (p ⬍0.01). Conclusions: This prospective study demonstrated that basal antral follicle number identifies patients who may respond poorly to IVF stimulation. A basal antral follicle number ⬍5 was associated with a high cancellation rate of 41% and in those not cancelled a low pregnancy rate of 23%. However, there was not antral follicle number at which the pregnancy rate or cancellation rate was 100% or 0%. This is valuable information allowing physicians to evaluate and counsel patients immediately prior to IVF and subsequently optimize stimulation protocols and resources. Supported by: WRAMC DCI.
Tuesday, October 15, 2002 4:30 P.M. O-115 Simultaneous vaginal oocyte retreival and laparascopic proximal occlusion of ultrasound visible hydrosalpinges improve the IVF outcome. Hamid Sahebkashaf, M. Aghahosseini, H. Saidi, N. Ghalavand, H. Ghavami Adel, S. Sahebkashaf. Navid‘s institute of infertility and Dept of infertility & endocrinology, Shariati Hosp, Tehran, Iran. Objective: An increasing body of literature has reported that either unilateral or bilateral hydrosalpinges may exert a deletrious effect on IVF-ET cycle outcome. Also there is report that only large hydrosalpinges which were visible on ultrasound resulted in reduced clinical and pregnancy rate. To address this issue we compare the clinical and ongoing pregnancy rate attained after simultaneous vaginal oocyte retreival and laparascopic proximal occlusion of ultrasound visible hydrosalpinges with no proximal tubal occlusion in traditional IVF. Design: A group of 180 consenting unilateral or bilateral ultrasound visible hydrosalpinges IVF patients (IRB APPROVED) were randomly
Vol. 78, No. 3, Suppl. 1, September 2002
Tuesday, October 15, 2002 4:00 P.M. O-113 Use of recombinant hCG results in reduced IVF pregnancy rates compared to non-recombinant u-hCG. Matthew G. Retzloff, Katharine V. Jackson, Janis H. Fox, Elizabeth S. Ginsburg, Catherine Racowsky. Ctr for Reproductive Medicine, Dept of Obstetrics, Gynecology and Reproductive Biology, Brigham and Women’s Hosp, Harvard Medical Sch, Boston, MA. Objective: Non-recombinant urinary hCG (u-hCG) has proven efficacy for controlled ovarian stimulation (COS) for purposes of IVF. A recombinant subcutaneous hCG (Ovidrel威) product has been introduced to replace u-hCG with presumed equivalent efficacy. This study was conducted to compare the overall effectiveness of Ovidrel vs. non-recombinant u-hCG (Novarel威, Profasi威, Pregnyl威). Design: Retrospective case-controlled series of IVF cycles utilizing Ovidrel (n ⫽ 112) or u-hCG (n ⫽ 112), performed from May 2001 to March 2002 at Brigham and Women’s Hospital, Boston, MA. Materials/Methods: All patients undergoing IVF between May 2001 and March 2002 were screened to identify those who received Ovidrel (250 mcg) prior to egg retrieval (n ⫽ 157). From this group, 112 patients were identified for whom controls receiving non-recombinant hCG (u-hCG; 10,000 IU IM) were available as matched by date of retrieval, age, attempt number, stimulation protocol, and follicle number. Each of the two hCG groups was compared with regards to time from hCG to retrieval, number of oocytes retrieved, number of mature oocytes (MII), egg:follicle (⬎12mm) ratio, MII:follicle ratio, fertilization rate per MII oocyte, total number embryos produced, mean number of embryos transferred, ongoingdelivered rates per embryo transfer (ET), and implantation rates. Statistical analyses were performed utilizing 2 or Wilcoxon Signed Rank tests where appropriate, with p ⬍0.05 considered statistically significant. Results: The u-hCG and Ovidrel groups did not differ for age (36.2 vs. 36.2y), number of follicles (⬎12mm) (12.8 vs. 12.3), peak estradiol (2091 vs. 2065 pg/ml), time from hCG to retrieval (36.1 vs. 36.1hr), or number of embryos transferred (3.45 vs. 3.39). Within each group, the distribution of patients by stimulation regimen (luteal down-regulation, flare, or GnRH antagonist) did not differ. However, in the Ovidrel group, there was a significant reduction in the egg:follicle ratio, the MII:follicle ratio and the total number of embryos obtained. Furthermore, the ongoing-delivered rate was significantly lower in the Ovidrel group. The relevant results are summarized in the table below
# Pts with ETs Attempt number Total # oocytes Total # MII Egg: Follicle MII: Follicle Total # embryos # Embryos transferred # OG-delivered/ET (%) Impl. rate (FH/#ET)
u-hCG 105
Ovidrel 97
P-value
1.45 ⫾ 0.50 13.2 ⫾ 7.7 10.1 ⫾ 6.0 1.08 ⫾ 0.41 0.835 ⫾ 0.37 7.53 ⫾ 5.27 3.45 ⫾ 1.56 52 (49.5%) 18.6%
1.24 ⫾ 0.43 11.9 ⫾ 6.9 8.9 ⫾ 5.5 0.98 ⫾ 0.33 0.731 ⫾ 0.28 6.37 ⫾ 4.40 3.39 ⫾ 1.54 33 (34.0%) 15.0%
0.003 0.036 NS 0.050 0.025 0.029 NS 0.037 NS
Conclusions: Our results indicate that recombinant hCG is not as effective as non-recombinant hCG for COS in IVF. Recombinant hCG had a negative impact on the total number of oocytes retrieved and the MII:follicle ratio, thereby resulting in a smaller “pool” of embryos from which to select for transfer. The collective effects of these differences led to a significantly higher ongoing-delivered pregnancy rate for non-recombinant preparations of hCG. Based on these data we recommend u-hCG rather than Ovidrel to maximize success in IVF. Supported by: None.
S44
Abstracts
Tuesday, October 15, 2002 4:15 P.M. O-114 Basal antral follicle number predicts IVF cycle pregnancy, cancellation, and ovarian responsiveness: A prospective study. John L. Frattarelli, Andy Levi, Bradley T. Miller, James H. Segars. Tripler Army Medical Ctr, Honolulu, HI; Combined Fed Program for Reproductive Endocrinology, NIH, Bethesda, MD; Reproductive Medicine Assoc of New Jersey, Morristown, NJ. Objective: The functional ovarian reserve as measured by basal antral follicle count has been suggested to predict follicular response in IVF. The objective of this study was to prospectively determine the predictive value and define threshold values for basal antral follicle number in patients undergoing IVF treatment. Design: An prospective analysis of 267 infertility patients at a tertiary care center undergoing ovarian assessment prior to IVF stimulation. Materials/Methods: All women had basal ovarian measurements performed on cycle day 3 prior to starting gonadotropins. Main outcome measures were the number of follicles produced, number of oocytes obtained, and cycle outcomes. To assess ovarian responsiveness, the pretreatment ovarian ultrasound measurements were compared with respect to patient’s age, day 3 estradiol, day 3 FSH, day 3 LH, peak estradiol, ampules of gonadotropins used, and days of stimulation. A linear regression model was used to identify any correlation between two continuous variables. Additional statistical analysis was performed using a one-way Analysis of Variance test, Kruskal-Wallis ANOVA, Wilcoxon-Mann-Whitney test for nonparametric data, t-test for parametric data, and a Chi-square test for trends. An alpha error of 0.05 was considered significant for all calculations. Results: Patients who became pregnant had a significantly greater number of antral follicles (13.8 ⫹/⫺ 7.5 vs. 12.4 ⫹/⫺ 10.0) (p ⬍0.01). Patients whose cycles were cancelled had significantly fewer antral follicles (7.6 ⫹/⫺ 4.8 vs. 13.7 ⫹/⫺ 8.8) (p ⬍0.01). Antral follicle number demonstrated a significant positive linear correlation with number of follicles, recovered oocytes, number of embryos, ovarian volume, day 3 LH, and peak estradiol (p ⬍0.05). A significant negative linear correlation was noted with ampules of gonadotropins used, days of stimulation, patient’s age, and day 3 FSH (p ⬍0.05). Threshold analysis demonstrated a lower pregnancy rate in patients with ⬍5 antral follicles (23.5% vs. 57.6%) (p ⬍0.01). Likewise, threshold analysis revealed a higher cancellation rate associated with ⬍5 antral follicles (41% vs. 6.9%) (p ⬍0.01). Conclusions: This prospective study demonstrated that basal antral follicle number identifies patients who may respond poorly to IVF stimulation. A basal antral follicle number ⬍5 was associated with a high cancellation rate of 41% and in those not cancelled a low pregnancy rate of 23%. However, there was not antral follicle number at which the pregnancy rate or cancellation rate was 100% or 0%. This is valuable information allowing physicians to evaluate and counsel patients immediately prior to IVF and subsequently optimize stimulation protocols and resources. Supported by: WRAMC DCI.
Tuesday, October 15, 2002 4:30 P.M. O-115 Simultaneous vaginal oocyte retreival and laparascopic proximal occlusion of ultrasound visible hydrosalpinges improve the IVF outcome. Hamid Sahebkashaf, M. Aghahosseini, H. Saidi, N. Ghalavand, H. Ghavami Adel, S. Sahebkashaf. Navid‘s institute of infertility and Dept of infertility & endocrinology, Shariati Hosp, Tehran, Iran. Objective: An increasing body of literature has reported that either unilateral or bilateral hydrosalpinges may exert a deletrious effect on IVF-ET cycle outcome. Also there is report that only large hydrosalpinges which were visible on ultrasound resulted in reduced clinical and pregnancy rate. To address this issue we compare the clinical and ongoing pregnancy rate attained after simultaneous vaginal oocyte retreival and laparascopic proximal occlusion of ultrasound visible hydrosalpinges with no proximal tubal occlusion in traditional IVF. Design: A group of 180 consenting unilateral or bilateral ultrasound visible hydrosalpinges IVF patients (IRB APPROVED) were randomly
Vol. 78, No. 3, Suppl. 1, September 2002