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Recombinant Human Chorionic Gonadotropin (RHCG): a comparison of 250 versus 400 mcg doses
Lynnette Nieman, Alicia Y. Armstrong. Univ of Colorado Health Science Ctr, Auroa, CO; Walter Reed Army Medical Ctr, Washington, DC; National Inst Health, Bethesda, MD; Reproductive Assoc of New Jersey, Bethesda, NJ. Objective: We sought to examine the impact of blastocyst transfers (BT) and the reduction in the number of embryos transferred on the HOM rate. The economic impact of reducing HOM gestations to the health care system was also examined. Design: Retrospective database review. Materials and Methods: The records of 1622 patients who initiated an ART cycle from January 1997-December 2000 were reviewed. In January 1998 a conservative policy on the number of embryos transferred was adopted. A blastocyst transfer program was fully implemented in July 1998. Direct and indirect costs for triplet gestation were estimated. Results: The mean number of embryos transferred declined from an average of 4.0 in 1997 to 3.4 for years 1998-2000. The HOM delivery rate for blastocyst transfer was significantly lower than for day 3 transfers (2.7% vs. 11.0% p⬍0.0001). During the period 1998-2000 the overall HOM rate decreased from 13.9% to 4.5%. The estimated family charge for a triplet gestation is $109,765. A reduction in the HOM rate from 13.9% to 4.5% would result in an estimated decrease costs to the medical system of $1,031,791 for every 100 cycles. Conclusion: Blastocyst transfer and a reduction in the number of embryos transferred are associated with a reduced HOM rate. In addition to the decrease in the numbers of HOM pregnancies, the predicted economic impact is significant and in our system was probably responsible for over $4 million saved.
ART: OVARIAN STIMULATION STANDARD PROTOCOLS P-178 Recombinant Human Chorionic Gonadotropin (RHCG): A comparison of 250 versus 400 mcg doses. Sigal Klipstein, Michael M. Alper. Beth Israel Deaconess Medical Ctr and Boston IVF, Boston, MA. Introduction: rhCG (Ovidrel, Serono Laboratories, Rockland, MA) has been available in the United States since 2000. A large initial study (1Chang et al) found the 250 mcg and 500 mcg doses equivalent to the standard 10,000 USP units of urinary hCG dose when comparing mean number of oocytes retrieved, total pregnancies and live births. While the number of cleaved embryos on the day of embryo transfer were higher with the 500 mcg dose as compared to the 250 mcg dose, there was a trend toward a higher frequency of ovarian hyperstimulation syndrome. Based upon these results, the 250 mcg dose was approved. Because of some concern that the 250 mcg dose may be inadequate in the occasional patient, Boston IVF switched to 400 mcg dosing. This study aims to compare outcomes between the commercially available 250 mcg dose and a tailor-made 400 mcg dose. Design: Retrospective analysis comparing IVF cycles triggered with 250 mcg vs. 400 mcg doses of rhCG. Materials and Methods: Beginning on 08/01/02, Boston IVF doctors preferentially recommended 400 mcg of Ovidrel in all patients undergoing IVF. Our database identified a total of 87 patients triggered with rhCG between April 2002 and March 2003. Of these, 36 received the 250 mcg dose and 51 received the 400 mcg dose. All patients were treated with a standard protocol of ovarian stimulation with rFSH (Gonal-F, Serono) following mid-luteal down-regulation with leuprolide acetate or cetrorelix acetate (Cetrotide, Serono) The following parameters were compared between the two groups: Age at cycle start, cycle number, number of follicles ⬎14 mm, total number of eggs retrieved, number of mature eggs, number of normal fertilizations, number of embryos transferred, number of embryos frozen, % normal fertilization, fertilization rate per mature oocytes and pregnancies. Statistical analysis was performed using the t-test, with p⬍0.05 considered statistically significant. Results: The two groups (250 mcg vs 400 mcg) did not differ significantly by age, cycle number, follicles ⬎14 mm, eggs retrieved, mature eggs, fertilized eggs, # embryos transferred, # frozen embryos, % fertilization, fertilization rate per mature oocytes and pregnancy rate. These results are summarized in Table 1.
FERTILITY & STERILITY威
A Comparison Between 250 and 400 mcg doses of rhCG
Conclusions: This study compared 250 and 400 mcg doses of rhCG to induce follicular maturation for IVF and found no differences with respect to number of mature follicles or eggs, number of normal fertilizations, number of embryos transferred or frozen, percentage of normal fertilizations, fertilization rate per mature egg and pregnancy rates. This preliminary study suggests that the 250 mcg dose of rhCG is equivalent to the higher 400 mcg dose for all parameters examined. 1Chang P, et al. (2001) Fertil Steril, 76(1)67-74.
P-179 Highly purified (hp)-hMG versus urinary (u)-hMG: A randomized study in oocyte donors. Juan M. Giles, Antonio Requena, Juan A. Garcia-Velasco, Alfredo Guillen, Jose Remohi. IVI Madrid, Madrid, Spain. Objective: To evaluate the clinical efficiency and patient tolerability of s.c hp-hMG (Menopur(c), Ferring Labs) vs i.m. u-hMG (hMG Lepori(c), Lepori Labs) in oocyte donors undergoing controlled ovarian hyperstimulation. Design: Prospective, randomized, controlled trial. Materials and Methods: A total of 52 oocyte donors were recruited between August and December 2002. Five patients were excluded from the study. After down regulation with GnRHa (nafarelin, Synarel(c), Seid Labs) in a long protocol, group 1 (26 donors) received 225 IU s.c.hp-hMG for 3 days, and then adjusted individually according to the ovarian response; group 2 (21 donors) received i.m u-hMG in a similar fashion. To evaluate local tolerance we checked skin redness, bruising, pain and itching at the injection place. Results: Both groups were comparable in terms of age (25.96 vs 27.04), BMI (21.49 vs 23.35 ), day 3 E2 (119.6 vs 116.63 pg/ml), peak E2 (2336.82 vs 2157.88 pg/ml), total dose of hMG administered (1717 vs 1845.23 UI) and cancellation rate (23.07% vs 23.8% ). A significantly shorter stimulation length was observed in patients receiving hp-hMG when compared to u-hMG (9.5 vs 10.42 days p⫽ 0.026). No significant differences were observed in the total number of oocytes retrieved (11.31 vs10.26), MII oocytes (79.67% vs 85.81%), fertilization rate (67.71 % vs 69.17 %) or mean number of embryos transferred (2.7 vs 2.81). Patient tolerability was significantly better with the use of s.c. hp-hMG, although no adverse effects were observed in any group. Hp –HMG compared favorably to u –HMG in all of tolerability parameters( pain 19.23% vs 52.38%, itching 26.92% vs 33.3%, skin redness 26.92% vs 47.61% and bruising 15.39% vs 28.57%) including global satisfaction rate (83% vs 53%). Conclusion: Both treatments showed a comparable clinical outcome and safety profile. There was a trend towards a better implantation and pregnancy rate with hp-hMG (IR: 65% vs 47.61%, PR: 52% vs 35.71%); however, differences did not reach statistical significance probably due to sample size. hp-hMG is associated with a shorter stimulation period and a better tolerability at the injection place.
P-180 Effect of length of stimulation in ART cycles on pregnancy rate. Kristen A. Ivani, Louis N. Weckstein, Denise M. Walker. Reproductive Science Ctr of the San Francisco Bay Area, San Ramon, CA. Objective: Past studies have suggested a negative impact of very long or very short stimulations on pregnancy rate in ART cycles. An excessively long cycle may suggest diminished ovarian reserve, and clinicians often are tempted to cancel these cycles prior to egg retrieval. A very short stimula-
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ART: OVARIAN STIMULATION STANDARD PROTOCOLS P-178 Recombinant Human Chorionic Gonadotropin (RHCG): A comparison of 250 versus 400 mcg doses. Sigal Klipstein, Michael M. Alper. Beth Israel Deaconess Medical Ctr and Boston IVF, Boston, MA. Introduction: rhCG (Ovidrel, Serono Laboratories, Rockland, MA) has been available in the United States since 2000. A large initial study (1Chang et al) found the 250 mcg and 500 mcg doses equivalent to the standard 10,000 USP units of urinary hCG dose when comparing mean number of oocytes retrieved, total pregnancies and live births. While the number of cleaved embryos on the day of embryo transfer were higher with the 500 mcg dose as compared to the 250 mcg dose, there was a trend toward a higher frequency of ovarian hyperstimulation syndrome. Based upon these results, the 250 mcg dose was approved. Because of some concern that the 250 mcg dose may be inadequate in the occasional patient, Boston IVF switched to 400 mcg dosing. This study aims to compare outcomes between the commercially available 250 mcg dose and a tailor-made 400 mcg dose. Design: Retrospective analysis comparing IVF cycles triggered with 250 mcg vs. 400 mcg doses of rhCG. Materials and Methods: Beginning on 08/01/02, Boston IVF doctors preferentially recommended 400 mcg of Ovidrel in all patients undergoing IVF. Our database identified a total of 87 patients triggered with rhCG between April 2002 and March 2003. Of these, 36 received the 250 mcg dose and 51 received the 400 mcg dose. All patients were treated with a standard protocol of ovarian stimulation with rFSH (Gonal-F, Serono) following mid-luteal down-regulation with leuprolide acetate or cetrorelix acetate (Cetrotide, Serono) The following parameters were compared between the two groups: Age at cycle start, cycle number, number of follicles ⬎14 mm, total number of eggs retrieved, number of mature eggs, number of normal fertilizations, number of embryos transferred, number of embryos frozen, % normal fertilization, fertilization rate per mature oocytes and pregnancies. Statistical analysis was performed using the t-test, with p⬍0.05 considered statistically significant. Results: The two groups (250 mcg vs 400 mcg) did not differ significantly by age, cycle number, follicles ⬎14 mm, eggs retrieved, mature eggs, fertilized eggs, # embryos transferred, # frozen embryos, % fertilization, fertilization rate per mature oocytes and pregnancy rate. These results are summarized in Table 1.
FERTILITY & STERILITY威
A Comparison Between 250 and 400 mcg doses of rhCG
Conclusions: This study compared 250 and 400 mcg doses of rhCG to induce follicular maturation for IVF and found no differences with respect to number of mature follicles or eggs, number of normal fertilizations, number of embryos transferred or frozen, percentage of normal fertilizations, fertilization rate per mature egg and pregnancy rates. This preliminary study suggests that the 250 mcg dose of rhCG is equivalent to the higher 400 mcg dose for all parameters examined. 1Chang P, et al. (2001) Fertil Steril, 76(1)67-74.
P-179 Highly purified (hp)-hMG versus urinary (u)-hMG: A randomized study in oocyte donors. Juan M. Giles, Antonio Requena, Juan A. Garcia-Velasco, Alfredo Guillen, Jose Remohi. IVI Madrid, Madrid, Spain. Objective: To evaluate the clinical efficiency and patient tolerability of s.c hp-hMG (Menopur(c), Ferring Labs) vs i.m. u-hMG (hMG Lepori(c), Lepori Labs) in oocyte donors undergoing controlled ovarian hyperstimulation. Design: Prospective, randomized, controlled trial. Materials and Methods: A total of 52 oocyte donors were recruited between August and December 2002. Five patients were excluded from the study. After down regulation with GnRHa (nafarelin, Synarel(c), Seid Labs) in a long protocol, group 1 (26 donors) received 225 IU s.c.hp-hMG for 3 days, and then adjusted individually according to the ovarian response; group 2 (21 donors) received i.m u-hMG in a similar fashion. To evaluate local tolerance we checked skin redness, bruising, pain and itching at the injection place. Results: Both groups were comparable in terms of age (25.96 vs 27.04), BMI (21.49 vs 23.35 ), day 3 E2 (119.6 vs 116.63 pg/ml), peak E2 (2336.82 vs 2157.88 pg/ml), total dose of hMG administered (1717 vs 1845.23 UI) and cancellation rate (23.07% vs 23.8% ). A significantly shorter stimulation length was observed in patients receiving hp-hMG when compared to u-hMG (9.5 vs 10.42 days p⫽ 0.026). No significant differences were observed in the total number of oocytes retrieved (11.31 vs10.26), MII oocytes (79.67% vs 85.81%), fertilization rate (67.71 % vs 69.17 %) or mean number of embryos transferred (2.7 vs 2.81). Patient tolerability was significantly better with the use of s.c. hp-hMG, although no adverse effects were observed in any group. Hp –HMG compared favorably to u –HMG in all of tolerability parameters( pain 19.23% vs 52.38%, itching 26.92% vs 33.3%, skin redness 26.92% vs 47.61% and bruising 15.39% vs 28.57%) including global satisfaction rate (83% vs 53%). Conclusion: Both treatments showed a comparable clinical outcome and safety profile. There was a trend towards a better implantation and pregnancy rate with hp-hMG (IR: 65% vs 47.61%, PR: 52% vs 35.71%); however, differences did not reach statistical significance probably due to sample size. hp-hMG is associated with a shorter stimulation period and a better tolerability at the injection place.
P-180 Effect of length of stimulation in ART cycles on pregnancy rate. Kristen A. Ivani, Louis N. Weckstein, Denise M. Walker. Reproductive Science Ctr of the San Francisco Bay Area, San Ramon, CA. Objective: Past studies have suggested a negative impact of very long or very short stimulations on pregnancy rate in ART cycles. An excessively long cycle may suggest diminished ovarian reserve, and clinicians often are tempted to cancel these cycles prior to egg retrieval. A very short stimula-
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