Increased Probability of Males Following IVF Treatment Versus ICSI

OBJECTIVE: To evaluate the development potential of embryos with early cleavage into top quality embryos and the impact of early cleavage on ongoing pregnancy rates in women undergoing IVF treatment. DESIGN: Analysis of a large, randomized, open-label, assessor-blind, multicenter, multinational trial (MERIT) comparing two gonadotropin preparations in IVF cycles with the long GnRH agonist protocol. MATERIALS AND METHODS: Embryo quality and ongoing pregnancy data were collected from 731 ovulatory women with tubal factor, mild male factor, endometriosis stage I/II or unexplained infertility. All were downregulated with triptorelin 0.1 mg SC daily from the mid-luteal phase and randomised to either HP-hMG (MENOPUR, Ferring Pharmaceuticals) (n⫽363) or recombinant FSH (GONAL-F, Serono) (n⫽368). The starting dose was 225 IU SC for the first five days and thereafter dose adjustments of 75 IU were allowed not more frequently than every four days. Recombinant hCG 250 ␮g SC was administered when 3 or more follicles of 17 mm or greater were observed. A total of 7535 oocytes were obtained. Embryo quality was evaluated at 28h, 44h and 68h (⫾1h) after standard IVF insemination locally at site and subsequently centrally by three independent embryologists based on digital images. All embryologists were blinded to treatment allocation and each others results. A top quality embryo was pre-defined as having 4-5 cells on Day 2, ⱖ 7 cells of equal size and ⱕ 20% fragmentation on Day 3 and no multinucleation. Transfer of 1-2 embryos of pre-defined quality criteria (minimum: ⱖ 4 cells with no cleavage arrest and ⱕ 20% fragmentation) was done on Day 3. Ongoing pregnancy was defined as at least one viable fetus 10-11 weeks after embryo transfer. The analysis was based on the central evaluation of embryos and included embryos for which individual outcome was determined, meaning all women with 0% or 100% ongoing implantation rate after single or double embryo transfer. RESULTS: A total of 1123 embryos were 2-cells at 28h based on the central evaluation. Embryos with 2-cells at 28h had a significantly (p⬍0.001) higher chance of developing into a top quality embryo (32%) compared to those embryos that were not 2-cells at 28h (5%). The ongoing pregnancy rate for women with transfer of top quality embryos was 39% with early cleaved embryos (2-cell at 28h) and 40% with not early cleaved embryos. Concerning non-top quality embryos, the ongoing pregnancy rate was 35% for women with transfer of early cleaved embryos which was significantly (p⬍0.05) higher than the 19% observed for embryos with no early cleavage. Among single embryo transfers, the ongoing pregnancy rate/implantation rate was 17% for embryos that were 1-cell at 28h compared to 36% for 2-cell embryos (p⬍0.05). For women with double-embryo transfer, the ongoing pregnancy rate was 36% when both embryos transferred were 2-cells at 28h and 29% when both embryos were 1-cells. CONCLUSION: Embryos that reach the 2-cells stage at 28h after insemination have a significantly higher chance of developing into top quality embryos. Information on early cleavage will not increase pregnancy rates when transferring top quality embryos on Day 3, but will dramatically increase the pregnancy rates if the embryo transferred is of non-top quality. Supported by: Ferring Pharmaceuticals A/S, Copenhagen, Denmark.

buffered with HEPES. As a control group, an equal number of insemination cycle outcomes involving identical sperm preparation techniques but no laboratory manipulation of oocytes or embryos were included. Cycle parameters analyzed for possible relationship with newborn sex ratios included number of eggs retrieved (total and mature), number of eggs fertilized (2-PN and ⬎2-PN), number of embryos (cleaved, transferred, frozen), average grade of embryos and average grade of transfer technique. Embryos were scored based on blastomere number and percent fragmentation to derive a semi-subjective value (1 to 5) which was averaged for embryos transferred per patient. Transfer score was a semi-subjective value (1 to 4) based on presence of mucus, blood, or retained embryos within the catheter following transcervical transfer, as well as time to complete procedure. Cycles resulting in a twin birth of one male and one female were not included. Bivariate analysis was conducted using logistic regression, Fisher’s Exact Test and chi square. A p-value of ⬍0.05 was considered statistically significant. RESULTS: A total of 62 cycles (36 IVF and 26 ICSI) were analyzed. No significant difference was found with respect to age at time of cycle between the two groups. The IVF procedure was significantly related to delivery of a male in bivariate analysis (Table 1). The probability of delivery of a newborn male was almost 8 times higher in patients who were inseminated by IVF compared to ICSI. An equal proportion of IUI outcomes during the same time period revealed no significant difference in sex ratio between newborn males and females (p⫽0.822). Table 1. Two-tailed Fisher’s Exact Test and chi-square p-values showing the association of IVF with the likelihood of delivering a male.

CONCLUSION: Patients in this review who were inseminated by IVF were approximately 8 times more likely to deliver a male than patients inseminated by ICSI. Further investigation with a larger sample size is warranted. Supported by: None.

P-380 WITHDRAWN P-381 Increased Probability of Males Following IVF Treatment Versus ICSI. J. A. MacDonald, B. J. Leonard, E. M. Carr, S. K. Jindal, J. P. Gaughan, G. S. Taliadouros. Delaware Valley Institute of Fertility and Genetics, Marlton, NJ; Temple University School of Medicine, Philadelphia, PA. OBJECTIVE: To evaluate the association between sex ratios in newborns and insemination technique in ART. DESIGN: Retrospective study. MATERIALS AND METHODS: All fresh IVF and ICSI cycles between January 2002 and December 2004 were identified. Standard insemination procedures were used for all patients. Analysis was limited to patients who conceived and delivered a live born baby. In all cycles analyzed, fresh ejaculated sperm was layered onto a density gradient (90% and 50%; Nidacon), centrifuged and washed twice in HTF (In Vitro Care) ⫹ 6% synthetic serum substitute (SSS; Irvine Scientific). Final sperm samples for ICSI were resuspended in HTF ⫹ 6% SSS

FERTILITY & STERILITY威

P-382 The Role of Embryo Quality in the Prediction of Early Pregnancy Loss Following ART. A. Hourvitz, L. Lerner-Geva, S. E. Elizur, M. Baum, J. Levron, J. Dor. IVF Unit, Chaim Sheba Medical Center, Ramat-Gan, Israel; Women and Children’s Health Research Unit, Gertner Institute for Epidemiology and Health Policy Research, Ramat-Gan, Israel. OBJECTIVE: Following implantation, approximately 20% of all recognized pregnancies failed to progress beyond the first trimester. This early pregnancy loss (EPL) significantly reduces the initial success rate of ART treatments and increases the psychological burden on the patient. Known risk factors for EPL include advanced maternal age, obesity and smoking. Although the well known association between karyotype abnormalities and EPL has been clearly documented, the role of embryo quality in EPL has not been comprehensively studied. The aim of the current study was to investigate the association between embryo quality and EPL in IVF treatment. DESIGN: A retrospective clinical study. MATERIALS AND METHODS: Analysis of all women undergoing IVF cycles in our IVF unit between July 2000 and October 2004 was performed for pregnancy and EPL. The risk factors for EPL investigated were: woman’s age,

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