Randomized clinical trial of preconception low dose aspirin use and time-to-pregnancy: the eager trial

RESULTS: The model demonstrates that IVF with microarray PGS costs $19,416 to achieve a live birth compared to $23,184 with IVF alone across all combined age groups. The average cost of undergoing IVF with PGS is $17,062 with an 87.9% chance of achieving a live birth over three pregnancy attempts, compared to an average cost of $14,887 and success rate of 64.2% for IVF alone. Monte-Carlo simulation revealed that IVF with PGS was costsaving in 16.6% of simulations and cost-effective in 83.4%. CONCLUSION: This model suggests that the addition of 23 chromosome microarray PGS to IVF is cost effective for couples with recurrent pregnancy loss across all maternal age groups compared to IVF alone over a wide range of probabilities and costs. Ongoing model analyses will include elective single embryo transfer and implications on the reduction of multiple gestations. O-326 Wednesday, October 16, 2013 11:30 AM THE RISK OF CONGENITAL MALFORMATIONS IN CHILDREN BORN AFTER ASSISTED REPRODUCTION IS ONLY INCREASED IN SOME ORGAN SYSTEMS: A NORDIC STUDY FROM THE CONL. B. Romundstad,b ARTAS GROUP. A.-K. A. Henningsen,a U.-B. Wennerholm,c M. Gissler,d S. Rasmussen,e A. Pinborg.a aFertility Clinic, Rigshospitalet, Copenhagen, Denmark; bDepartment of Obstetrics and Gynecology, St Olavs University Hospital, Trondheim, Norway; cDepartment of Obstetrics and Gynaecology, Sahlgrenska University Hospital, Goteborg, Sweden; dTHL, National Institute for Health and Welfare, Helsinki, Finland; eHvidovre Hospital, University of Copenhagen, Copenhagen, Denmark. OBJECTIVE: To investigate the risk of malformations in specific organ systems among children conceived after ART. DESIGN: Population-based study on singletons (n¼58 714) and twins (n¼27 919) born after in-vitro fertilization (IVF), intracytoplasmatic sperm injection (ICSI) and frozen embryo transfer (FER) in Denmark, Finland, Norway and Sweden. Data were included from when the national ART registers were established until 2007. The ART singletons were matched on mother’s parity and year of birth with a control group of spontaneously conceived singletons four-fold the size. All spontaneously conceived twins born within the study period were also included in the control group. MATERIALS AND METHODS: The malformations were classified using EUROCAT’s classification system and grouped by organ system. Logistic regression analyses were used to calculate the odds ratios with adjustment for mother’s parity, year of birth, maternal age, child’s sex and country. RESULTS: In the analyses on all ART children only the risk of congenital heart malformations was increased in the adjusted analyses, odds ratio (OR) 1.12, confidence interval (CI) [1.03-1.22]. In the crude analyses, we found ART children to have an increased risk of gastrointestinal, urogenital and abdominal wall defects, OR 1.25 [95%CI 1.06-1.49]; OR 1.36 [95%CI 1.18-1.57] and OR 1.97 [95%CI 1.48-2.61] respectively. When restricting the analyses to singletons, we found that ART increased the risk of both congenital heart malformations, OR 1.20 [95%CI 1.00-1.45]; gastrointestinal malformations, OR 1.56 [95%CI 1.15-2.14] and urogenital malformations, OR 1.49 [95%CI 1.01-2.20] even after adjustment for known confounders. CONCLUSION: The risk of congenital malformations in children conceived after ART is only increased for malformations regarding the heart, gastrointestinal and urogenital organ system. Supported by: ESHRE; University of Copenhagen; Danish Agency for Science, Technology and Innovation and the Nordic Federation of Obstetrics and Gynecology (NFOG).

1) restricted: women with 1 documented loss <20 weeks gestational age (GA) during the past year, or 2) general: women with 1-2 prior losses regardless of GA or time since loss. Participants were treated/followed for up to 6 menstrual cycles. MATERIALS AND METHODS: Kaplan-Meier estimates were used to compare the time from randomization to a positive clinic urine pregnancy test (PPT) or clinically confirmed pregnancy by ultrasound at 6-7 weeks GA between the LDA and placebo groups. An intent-to-treat approach was used to estimate effects overall and by strata. RESULTS: 1228 women were randomized: 615 LDA and 613 placebo. Overall, 402 women had a PPT, and 378 a clinically confirmed pregnancy in the LDA group, and 374 and 350, respectively, in the placebo group. LDA was associated with a shorter time to PPT overall and within the restricted stratum (median TTP 3 and 4 cycles for LDA and placebo, respectively; overall log-rank P¼0.04, restricted log-rank P¼0.01), but not in the general stratum (log-rank P¼0.6). LDA was also associated with a shorter time to clinically confirmed pregnancy in the restricted stratum (P¼0.02), though was only marginally significant overall (P¼0.06). CONCLUSION: Daily LDA initiated preconception was associated with a significant decrease in time to PPT among women with 1-2 prior losses, and was associated with a shorter time to clinically confirmed pregnancy among women with a single documented loss <20 weeks GA during the past year. Supported by: Intramural Research Program of the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health. O-328 Wednesday, October 16, 2013 12:00 PM BLACK WOMEN WITH POLYCYSTIC OVARY SYNDROME (PCOS) HAVE INCREASED RISK FOR METABOLIC SYNDROME (MET SYN) AND CARDIOVASCULAR DISEASE (CVD) COMPARED TO WHITE WOMEN WITH PCOS. J. K. Hillman,a L. N. C. Johnson,a M. Limaye,a R. A. Feldman,b M. Sammel,c A. Dokras.a aObstetrics and Gynecology, University of Pennsylvania, Philadelphia, PA; bIcahn School of Medicine at Mount Sinai, New York, NY; cEpidemiology and Biostatistics, University of Pennsylvania, Philadelphia, PA. OBJECTIVE: Women with PCOS have an increased risk of Met Syn compared to controls. There is limited information on racial differences in cardiometabolic risk in PCOS. Our objective was to determine the prevalence of Met Syn and CVD risk in white and black women with PCOS and compare to controls. DESIGN: Retrospective chart review. MATERIALS AND METHODS: Women with well-defined PCOS with information on race and cardiometabolic risk were included. Met Syn was defined as 3 of 5 criteria (Table). Controls were age matched from the NHANES population. RESULTS: Black women with PCOS have a significantly increased prevalence of Met Syn and general CVD risk score compared to white women with PCOS (RR for met syn¼1.77 (95% CI 1.2-2.6). Cardiometabolic Risk in PCOS

AgeSE TestosteroneSE ng/dL O-327 Wednesday, October 16, 2013 11:45 AM RANDOMIZED CLINICAL TRIAL OF PRECONCEPTION LOW DOSE ASPIRIN USE AND TIME-TO-PREGNANCY: THE EAGER TRIAL. E. F. Schisterman,a R. M. Silver,b S. L. Mumford,a N. Galai,c J. Wactawski-Wende,4 J. B. Stanford.b aDivision of Epidemiology, Statistics, and Prevention Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Rockville, MD; bUniversity of Utah, Salt Lake City, UT; cUniversity of Haifa, Mount Carmel, Haifa, Israel. OBJECTIVE: To evaluate whether low dose aspirin (LDA) initiated preconception (81 mg/day) is associated with time-to-pregnancy (TTP) among women with 1-2 prior losses. DESIGN: This prospective randomized double-blind placebo-controlled trial recruited women with 1-2 prior losses, aged 18-40 actively trying to conceive. Women were stratified by site as well as by two types of eligibility:

S100

ASRM Abstracts

TGR150 mg/dL HDL%50 mg/dL BMIR30 kg/m2 BPR130/85 mmHg GlucoseR100 mg/dL Metabolic Syndrome (R3 criteria) Framingham 10-yr General CVD Risk 2008

PCOS White (n¼280)

PCOS Black (n¼80)

27.90.3 60.18 2

28.80.6 75.30 4.3#

23.5% 36.7% 53.2% 33.5% 24.4% 24.4% 1.42%

10.8%** 77.03%** 74.6%x 46.8% 42.7%** 42.6%** 2.23%#

# p<0.01, ** age/BMI adjusted p<0.01, x age adjusted p<0.05. There was no difference in risk of Met Syn between white and black women in the NHANES dataset. The RR for Met Syn in white women

Vol. 100, No. 3, Supplement, September 2013