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technician on fertilization rate and embryo quality following ICSI and pregnancy rate following embryo transfer procedures
TABLE 1.
% Cesarean Deliveries
Total
<31
31–33
34–37
38–40
>40
All cases Singleton
48.9 39.5
40.3 25.6
47.3 33.3
48.5 41.7
57.1 50
61.1 58
Perinatal outcomes: With advancing maternal age the incidence of preterm and very preterm deliveries increased in singleton pregnancies. TABLE 2.
Perinatal outcomes Preterm delivery (all) Preterm delivery (singleton) Very preterm delivery (all) Very preterm delivery (singleton)
Total
%37 yo
R38 yo
P
24.82% 13.66% 3.24% 1.95%
25.23% 13% 2.75% 1.3%
23.3% 15.68% 5% 4%
NS P<0.05 P<0.05 P<0.05
Low birth weight (<2500 gm) occurred in 29.8% (singleton, 11.1%; twins, 50.7%) and very low birth weight (<1500 gm) occurred in 4.5% (singleton, 1.9%; twins, 7.1%). CONCLUSIONS: This study suggests that singleton and twin ART pregnancies are associated with high rates of complications which increase with advancing maternal age. Increased fetal and maternal surveillance is warranted in these pregnancies. Supported by: None.
P-10 RE-ANALYSIS OF VAGINAL PROGESTERONE AS LUTEAL PHASE SUPPORT (LPS) IN ASSISTED REPRODUCTION (ART) CYCLES. P. W. Zarutskie, J. A. Phillips. President, Sage Statistical Solutions, Inc., Efland, NC; Zarutskie Fertility & Endocrine Institute, Laguna Niguel, CA. OBJECTIVE: To re-analyze the 2006 Cochrane meta-analysis of LPS: vaginal vs. i.m. progesterone (P). For LPS support in ART cycles, daily dosing of: 50 mg P in oil i.m. (IMP); or 600–800 mg micronized P in oil oral capsules, vaginally (200 mg TID-QID); or Crinone 8% bioadhesive gel (90 mg P) provide equivalent efficacy. The 2006 Cochrane review concluded: ‘‘Comparing routes of progesterone administration,...there was evidence of benefit of the intramuscular over the vaginal route for the outcomes of ongoing pregnancy and live birth.’’ An evaluation of the support for this conclusion reveals that a study with inadequate vaginal dosing was included. That study compared 200 mg of micronized P in a non-bioadhesive vaginal cream with IMP. The under dosed study should not have been included in their meta-analysis, 200 mg of P in a non-bioadhesive vaginal formulation is inadequate. Also, a recent study reported in 2006 compared Crinone 8% to IMP; the authors reported their interim results of ‘‘Clinical Pregnancy’’ in 215 patients. In the table below the under dosed study has been removed and the data have been re-analyzed. In addition, the results from the recent, 2006, study has been added to the ‘‘Clinical Pregnancy’’ analysis. DESIGN: A re-analysis of a prior meta-analysis. RESULTS: A re-analysis was not performed when <2 studies remained. TABLE 1. Re-analysis of luteal phase support: IM vs. Vaginal
Number of Studies
Analysis 1
Clinical Pregnancy Ongoing Pregnancy2 Miscarriage
10 5 5
Overall Proportion Progesterone Vaginal
Overall Proportion Odds Progesterone IM Ratio
is associated with a significantly lower rate of miscarriage than IMP. There are not enough studies reporting on Live Birth to conduct a meta-analysis. Supported by: This re-analysis was supported by Columbia Laboratories, Inc. P-11 THE EFFECT OF THE EMBRYOLOGIST/TECHNICIAN ON FERTILIZATION RATE AND EMBRYO QUALITY FOLLOWING ICSI AND PREGNANCY RATE FOLLOWING EMBRYO TRANSFER PROCEDURES. B. Balaban, A. Isiklar, B. Ata, K. Yakin, B. Urman. Assisted Reproduction Unit, VKF American Hospital of Istanbul, Istanbul, Turkey. OBJECTIVE: The aim of this study was to evaluate the effect of different embryologist/technicians on outcomes of ICSI and embryo transfer procedures. DESIGN: Retrospective analysis. MATERIALS AND METHODS: Outcome of ICSI on 27977 MII oocytes and 4175 embryo transfers performed by 7 different embryologist/technicians in a single assisted reproduction unit were analyzed. All embryologists/technicians working in the unit had undergone a standardized training period of one year before starting to work without supervision in the embryology laboratory. Outcome measures for the ICSI procedure were fertilization, degeneration, and cleavage rates, and the yield of good quality embryos. Outcome measure for ET was the clinical pregnancy rate. Categorical data was compared with the Chi-square test. RESULTS: Fertilization, degeneration, cleavage rates and the yield of good quality embryos were not different following performance of ICSI by different members of the staff (Table 1). Clinical pregnancy rates likewise were not significantly different (Table 2). Outcomes were not correlated with the duration of employment in the embryology laboratory.
TABLE 1. ET applicant Experience with ET No. of MII injected Fertilization (%) Degeneration (%) Cleavage (%) Good quality embryos (G1 þ G2) (%)
1
2
3
4
5
6
7
12 1120 850 (75.9) 34 (3.0) 836 (98.3) 376 (44.9)
10 1443 1084 (75.1) 43 (2.9) 1063 (98.0) 479 (45.0)
8 5156 3920 (76.0) 165 (3.2) 3838 (97.9) 1724 (44.9)
7 5127 3957 (77.1) 164 (3.1) 3878 (98.0) 1703 (43.9)
4 5281 4120 (78.0) 180 (3.4) 4046 (98.2) 1801 (44.5)
3 4893 3768 (77.0) 166 (3.3) 3704 (98.3) 1660 (44.8)
2 4957 3816 (76.9) 159 (3.2) 3740 (98.0) 1728 (45.0)
None were significant. TABLE 2. ET applicant
Experience with ET (years)
Clinical pregnancy/ET (%)*
12 10 9 8 5 4 3
411/1026 (40.0) 728/1775 (41.0) 147/363 (40.4) 123/286 (43.0) 132/305 (43.2) 120/242 (49.5) 84/178 (47.1)
1 2 3 4 5 6 7
ET: embryo transfer, *P¼0.1. 95% CI
257/827 (31.1%) 261/830 (31.5%) 0.989 [0.80, 1.22] 97/372 (26.1%) 97/372 (26.1%) 1.00 [0.72, 1.41] 14/113 (12.4%) 29/126 (23%) 0.48 [0.24, 0.99]
CONCLUSIONS: Following a standardized training period and completion of the learning curve, performance of different procedures in the embryology laboratory by different members of the staff does not seem to affect the success in terms of fertilization, embryo quality, and clinical pregnancy rates. Supported by: None.
1
Clinical Pregnancy – defined as a positive serum hCG and confirmed gestational sac on ultrasound, or clinical findings of trophoblasts, or an ectopic gestation. 2 Ongoing Pregnancy – defined as a viable pregnancy confirmed at 20 weeks gestation; The percentages were coincidentally identical. CONCLUSIONS: Daily administration of vaginal progesterone (Crinone 8% or 600 mg in a non-bioadhesive formulation) is comparable to daily administration of 50 mg i.m. progesterone for luteal phase support of ART cycles based on this meta-analysis of Ongoing and Clinical Pregnancy and
FERTILITY & STERILITYÒ
P-12 CLINICAL USE OF DAY 6 BLASTOCYSTS. H. Watanabe, A. Yanaihara, S. Monzen, T. Yorimitsu, H. Motoyama, T. Kawamura. Reproductive Center, Denentoshi Ladies Clinic, Yokohama, Kanagawa, Japan. OBJECTIVE: Manipulation of late-developing embryos on day 5 was evaluated for implantation potential. In this study, pregnancy rates were compared between fresh embryo transfer on day 5 (day 5 BL ET), Day 6 (day 6
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% Cesarean Deliveries
Total
<31
31–33
34–37
38–40
>40
All cases Singleton
48.9 39.5
40.3 25.6
47.3 33.3
48.5 41.7
57.1 50
61.1 58
Perinatal outcomes: With advancing maternal age the incidence of preterm and very preterm deliveries increased in singleton pregnancies. TABLE 2.
Perinatal outcomes Preterm delivery (all) Preterm delivery (singleton) Very preterm delivery (all) Very preterm delivery (singleton)
Total
%37 yo
R38 yo
P
24.82% 13.66% 3.24% 1.95%
25.23% 13% 2.75% 1.3%
23.3% 15.68% 5% 4%
NS P<0.05 P<0.05 P<0.05
Low birth weight (<2500 gm) occurred in 29.8% (singleton, 11.1%; twins, 50.7%) and very low birth weight (<1500 gm) occurred in 4.5% (singleton, 1.9%; twins, 7.1%). CONCLUSIONS: This study suggests that singleton and twin ART pregnancies are associated with high rates of complications which increase with advancing maternal age. Increased fetal and maternal surveillance is warranted in these pregnancies. Supported by: None.
P-10 RE-ANALYSIS OF VAGINAL PROGESTERONE AS LUTEAL PHASE SUPPORT (LPS) IN ASSISTED REPRODUCTION (ART) CYCLES. P. W. Zarutskie, J. A. Phillips. President, Sage Statistical Solutions, Inc., Efland, NC; Zarutskie Fertility & Endocrine Institute, Laguna Niguel, CA. OBJECTIVE: To re-analyze the 2006 Cochrane meta-analysis of LPS: vaginal vs. i.m. progesterone (P). For LPS support in ART cycles, daily dosing of: 50 mg P in oil i.m. (IMP); or 600–800 mg micronized P in oil oral capsules, vaginally (200 mg TID-QID); or Crinone 8% bioadhesive gel (90 mg P) provide equivalent efficacy. The 2006 Cochrane review concluded: ‘‘Comparing routes of progesterone administration,...there was evidence of benefit of the intramuscular over the vaginal route for the outcomes of ongoing pregnancy and live birth.’’ An evaluation of the support for this conclusion reveals that a study with inadequate vaginal dosing was included. That study compared 200 mg of micronized P in a non-bioadhesive vaginal cream with IMP. The under dosed study should not have been included in their meta-analysis, 200 mg of P in a non-bioadhesive vaginal formulation is inadequate. Also, a recent study reported in 2006 compared Crinone 8% to IMP; the authors reported their interim results of ‘‘Clinical Pregnancy’’ in 215 patients. In the table below the under dosed study has been removed and the data have been re-analyzed. In addition, the results from the recent, 2006, study has been added to the ‘‘Clinical Pregnancy’’ analysis. DESIGN: A re-analysis of a prior meta-analysis. RESULTS: A re-analysis was not performed when <2 studies remained. TABLE 1. Re-analysis of luteal phase support: IM vs. Vaginal
Number of Studies
Analysis 1
Clinical Pregnancy Ongoing Pregnancy2 Miscarriage
10 5 5
Overall Proportion Progesterone Vaginal
Overall Proportion Odds Progesterone IM Ratio
is associated with a significantly lower rate of miscarriage than IMP. There are not enough studies reporting on Live Birth to conduct a meta-analysis. Supported by: This re-analysis was supported by Columbia Laboratories, Inc. P-11 THE EFFECT OF THE EMBRYOLOGIST/TECHNICIAN ON FERTILIZATION RATE AND EMBRYO QUALITY FOLLOWING ICSI AND PREGNANCY RATE FOLLOWING EMBRYO TRANSFER PROCEDURES. B. Balaban, A. Isiklar, B. Ata, K. Yakin, B. Urman. Assisted Reproduction Unit, VKF American Hospital of Istanbul, Istanbul, Turkey. OBJECTIVE: The aim of this study was to evaluate the effect of different embryologist/technicians on outcomes of ICSI and embryo transfer procedures. DESIGN: Retrospective analysis. MATERIALS AND METHODS: Outcome of ICSI on 27977 MII oocytes and 4175 embryo transfers performed by 7 different embryologist/technicians in a single assisted reproduction unit were analyzed. All embryologists/technicians working in the unit had undergone a standardized training period of one year before starting to work without supervision in the embryology laboratory. Outcome measures for the ICSI procedure were fertilization, degeneration, and cleavage rates, and the yield of good quality embryos. Outcome measure for ET was the clinical pregnancy rate. Categorical data was compared with the Chi-square test. RESULTS: Fertilization, degeneration, cleavage rates and the yield of good quality embryos were not different following performance of ICSI by different members of the staff (Table 1). Clinical pregnancy rates likewise were not significantly different (Table 2). Outcomes were not correlated with the duration of employment in the embryology laboratory.
TABLE 1. ET applicant Experience with ET No. of MII injected Fertilization (%) Degeneration (%) Cleavage (%) Good quality embryos (G1 þ G2) (%)
1
2
3
4
5
6
7
12 1120 850 (75.9) 34 (3.0) 836 (98.3) 376 (44.9)
10 1443 1084 (75.1) 43 (2.9) 1063 (98.0) 479 (45.0)
8 5156 3920 (76.0) 165 (3.2) 3838 (97.9) 1724 (44.9)
7 5127 3957 (77.1) 164 (3.1) 3878 (98.0) 1703 (43.9)
4 5281 4120 (78.0) 180 (3.4) 4046 (98.2) 1801 (44.5)
3 4893 3768 (77.0) 166 (3.3) 3704 (98.3) 1660 (44.8)
2 4957 3816 (76.9) 159 (3.2) 3740 (98.0) 1728 (45.0)
None were significant. TABLE 2. ET applicant
Experience with ET (years)
Clinical pregnancy/ET (%)*
12 10 9 8 5 4 3
411/1026 (40.0) 728/1775 (41.0) 147/363 (40.4) 123/286 (43.0) 132/305 (43.2) 120/242 (49.5) 84/178 (47.1)
1 2 3 4 5 6 7
ET: embryo transfer, *P¼0.1. 95% CI
257/827 (31.1%) 261/830 (31.5%) 0.989 [0.80, 1.22] 97/372 (26.1%) 97/372 (26.1%) 1.00 [0.72, 1.41] 14/113 (12.4%) 29/126 (23%) 0.48 [0.24, 0.99]
CONCLUSIONS: Following a standardized training period and completion of the learning curve, performance of different procedures in the embryology laboratory by different members of the staff does not seem to affect the success in terms of fertilization, embryo quality, and clinical pregnancy rates. Supported by: None.
1
Clinical Pregnancy – defined as a positive serum hCG and confirmed gestational sac on ultrasound, or clinical findings of trophoblasts, or an ectopic gestation. 2 Ongoing Pregnancy – defined as a viable pregnancy confirmed at 20 weeks gestation; The percentages were coincidentally identical. CONCLUSIONS: Daily administration of vaginal progesterone (Crinone 8% or 600 mg in a non-bioadhesive formulation) is comparable to daily administration of 50 mg i.m. progesterone for luteal phase support of ART cycles based on this meta-analysis of Ongoing and Clinical Pregnancy and
FERTILITY & STERILITYÒ
P-12 CLINICAL USE OF DAY 6 BLASTOCYSTS. H. Watanabe, A. Yanaihara, S. Monzen, T. Yorimitsu, H. Motoyama, T. Kawamura. Reproductive Center, Denentoshi Ladies Clinic, Yokohama, Kanagawa, Japan. OBJECTIVE: Manipulation of late-developing embryos on day 5 was evaluated for implantation potential. In this study, pregnancy rates were compared between fresh embryo transfer on day 5 (day 5 BL ET), Day 6 (day 6
S113