Electronic Monitoring of Mom's Schedule (eMOMSTM): A Qualitative Study of Experiences in a Lifestyle Change Program with Lactation Support.

PURPOSE: To elicit feedback from participants who completed the eMOMSTM study, a feasibility randomized controlled trial (NCT04021602), on their perceptions of program strengths and weaknesses. STUDY DESIGN: Qualitative - Semi-structured, telephone interview guide using open-ended questions. SETTING: Rural Great Plains state, United States. PARTICIPANTS: Of 26 individuals who completed the eMOMSTM study, 24 consented to an interview. METHOD: Interviews were completed between October 2020 and May 2021. Audio-recordings were transcribed verbatim and organized in Microsoft 365. Data were analyzed using an exploratory, inductive thematic analysis. RESULTS: Participants' mean age was 27.5 (± 5.4) years and mean pre-pregnancy BMI was 29.5 kg/m2 (± 2.7). The majority (71%) were non-Hispanic White and 54% had a high school education/some college. Based on specific areas of inquiry, the following themes emerged: convenience of online program access using Facebook, importance of health coach's support and online interaction, positivity toward improving one's health, increased consciousness of health behaviors, diverse lactation educational needs, importance of educational materials on depression, and grief over the loss of birth expectations during COVID-19. CONCLUSION: Findings suggest participants' perceived value of a lifestyle change program coupled with lactation education and support delivered using social media. Findings inform future studies to further adapt lifestyle change programs.

Electronic Monitoring Of Mom's Schedule (eMOMSTM): Recruitment of pregnant populations with elevated BMI in a feasibility randomized controlled trial.

Underrepresentation of pregnant populations in randomized controlled trials of lifestyle change interventions is concerning due to high attrition and providers' limited clinical time. The purpose of this evaluative study was to assess intervention uptake of pregnant individuals enrolled in a three-arm feasibility randomized controlled trial, electronic Monitoring Of Mom's Schedule (eMOMSTM), examining lifestyle changes and lactation support alone, and in combination. Measures included: (1) participation and completion rates, and characteristics of intervention completers versus other eligible participants; and (2) provider experiences with screening and enrolling pregnant participants. Pregnant people with a pre-pregnancy body mass index ≥ 25 and < 35 kg/m2 were enrolled into the eMOMSTM trial between September 2019 - December 2020. Of the 44 consented participants, 35 were randomized, at a participation rate of 35%, and 26 completed the intervention, resulting in a completion rate of 74%. Intervention completers were slightly older and entered the study earlier in pregnancy compared to non-completers. Completers were more likely to be first-time mothers, resided in urban areas, had higher educational attainment, and were slightly more racially and ethnically diverse. A majority of providers reported willingness to participate, believed the study aligned with their organization's mission, and were satisfied with using iPads for screening. Lessons learned to guide recruitment success include use of: (1) designated research staff in combination with physician support; and (2) user-friendly technology to help mitigate time burden on physicians and their staff. Future work should focus on successful strategies to recruit/retain pregnant populations in clinical trials.

Electronic Monitoring Of Mom's Schedule (eMOMS™): Protocol for a feasibility randomized controlled trial to improve postpartum weight, blood sugars, and breastfeeding among high BMI women.

BACKGROUND: Overweight and obesity are major risk factors for gestational diabetes among U.S. women. Evidence suggests that longer duration of breastfeeding among women with a history of gestational diabetes is associated with lower incidence of developing type 2 diabetes after pregnancy. Women may potentially benefit from a lifestyle change program that includes breastfeeding education and support. PURPOSE: To describe the design and justification of a combined breastfeeding, national Diabetes Prevention Program (DPP)-based feasibility randomized controlled trial, the electronic Monitoring Of Mom's Schedule (eMOMSTM) study. eMOMSTM compares the feasibility and efficacy of three interventions on six-month postpartum weight loss among women with a BMI ≥25. METHODS: The intervention is delivered via Facebook and includes three groups: DPP and breastfeeding (eMOMS1); DPP only (eMOMS2); and Usual Care (eMOMS3). Recruitment is ongoing at two clinical sites (rural and urban). A total of 72 women, 24 per group, will be randomly assigned to one of the three groups. It is anticipated that women in eMOMS1 will have greater weight loss and increased length of breastfeeding at three and six months postpartum compared to women in eMOMS2 and eMOMS3. Additional data will be collected on metabolic markers, anthropometrics, physical activity, nutrition, breastfeeding, and depression. Program cost will be compared to that of traditionally scheduled group meetings. Expected study completion date: October 2021. CONCLUSIONS: This study has the potential to define a high impact, cost effective intervention that can improve public health by reducing negative health outcomes associated with gestational diabetes among an at-risk population.

30 years of data: impact of the United States in vitro fertilization data registry on advancing fertility care.

OBJECTIVE: To summarize and assess the impact of key research generated through the Society of Assisted Reproductive Technology (SART)-initiated United States IVF registry and annual reporting system. DESIGN: Review. SETTING: Eligible studies included those that analyzed data generated by the National IVF data collection program (through SART or Centers for Disease Control and Prevention). PATIENT(S): Not applicable. INTERVENTION(S): Not applicable. MAIN OUTCOME MEASURE(S): Summarize and report outcomes of research using National IVF registry data. RESULT(S): The Society of Assisted Reproductive Technology was founded in 1985 and published the first annual US IVF data report 30 years ago in 1988 in Fertility and Sterility. In 1995, the Centers for Disease Control and Prevention subsequently began collecting data from IVF programs and published their first report in 1997. This annual National IVF data collection and reporting is a significant responsibility and effort for IVF programs. Using these data sources, 199 articles have been published by clinicians and researchers from across the country. This research has guided the development of evidence-based assisted reproductive technology (ART) practice guidelines during the past 30 years, which have ultimately led to improved quality and patient care. CONCLUSION(S): Since the first SART National IVF data report publication 30 years ago, SART has achieved its original goals of creating a national IVF registry that successfully assesses clinical effectiveness, quality of care, and safety.

Prescribing Bioidentical Menopausal Hormone Therapy: A Survey of Physician Views and Practices.

BACKGROUND: It is estimated that 1-2.5 million U.S. women use compounded bioidentical menopausal hormone therapy (MHT). However, the proportion of American physicians prescribing compounded bioidentical hormones remains unknown. This study aims to evaluate obstetrician-gynecologists' (OB/GYNs) and family medicine physicians' decisions reflected in prescribing practices of MHT in Kansas, and level of agreement with the American College of Obstetricians and Gynecologists (ACOG) recommendations. METHODS: An Internet-based 38-item survey was electronically disseminated to OB/GYNs and family medicine physicians identified through the Kansas State Board of Healing Arts licensure list. RESULTS: Out of 1349 physicians contacted, 164 (12.2%) responded to the survey. There were 128 (9.5%) responses included in the final analysis. In the past year, 96.1% (123/128) of respondents prescribed conventional MHT, 93.0% (119/128) prescribed Food and Drug Administration (FDA)-approved bioidentical MHT, and 66.1% (84/127) prescribed compounded bioidentical MHT. Of factors influencing MHT-prescribing practices, FDA regulation was not important to 16.7% (21/126) of physicians, whereas customization was important to 68.5% (87/127). There was a significant difference between specialties, 37.7% of OB/GYNs compared with 56.9% of family medicine physicians, regarding the ACOG statement that "patients should be counseled that conventional MHT is more appropriate than compounded preparations" (p = 0.031). Respondents disagreed with ACOG regarding the statements that "the practice of compounding makes it difficult to identify the active agent responsible for various effects" (41.0% of OB/GYNs and 34.8% of family medicine physicians) and "the practice of custom blending commercially available drug products lacks both a strong biological rationale and medical evidence for effectiveness" (36.1% of OB/GYNs and 37.9% of family medicine physicians). CONCLUSIONS: Prescribing practices for MHT vary between specialties. This study identifies a meaningful level of disagreement with ACOG recommendations regarding prescription of compounded rather than FDA-approved MHT. Further research is needed to better understand this level of discordance.

National trends and outcomes of autologous in vitro fertilization cycles among women ages 40 years and older.

PURPOSE: The purpose of the study was to describe trends in and investigate variables associated with clinical pregnancy and live birth in autologous in vitro fertilization (IVF) cycles among women ≥40 years. METHODS: We used autologous IVF cycle data from the National ART Surveillance System (NASS) for women ≥40 years at cycle start. We assessed trends in fresh and frozen cycles (n = 371,536) from 1996 to 2013. We reported perinatal outcomes and determined variables associated with clinical pregnancy and live birth in fresh cycles between 2007 and 2013. RESULTS: From 1996 to 2013, the total number of cycles in women ≥40 years increased from 8672 to 28,883 (p < 0.0001), with frozen cycles almost tripling in the last 8 years. Cycles in women ≥40 years accounted for 16.0% of all cycles in 1996 and 21.0% in 2013 (p < 0.0001). For fresh cycles from 2007 to 2013 (n = 157,890), the cancelation rate was 17.1%. Among cycles resulting in transfer (n = 112,414), the live birth rate was 16.1%. The following were associated with higher live birth rates: multiparity, fewer prior ART cycles, use of standard agonist or antagonist stimulation, lower gonadotropin dose, ovarian hyperstimulation syndrome, more oocytes retrieved, use of pre-implantation genetic screening/diagnosis, transferring more and/or blastocyst stage embryos, and cryopreserving more supernumerary embryos. Of the singleton infants born (n = 14,992), 86.9% were full term and 88.3% normal birth weight. CONCLUSIONS: The NASS allows for a comprehensive description of IVF cycles in women ≥40 years in the USA. Although live birth rate is less than 20%, identifying factors associated with IVF success can facilitate treatment option counseling.

Evaluation of Multiple Biological Therapies for Ischemic Cardiac Disease.

The development of cell- and gene-based strategies for regenerative medicine offers a therapeutic option for the repair and potential regeneration of damaged cardiac tissue post-myocardial infarction (MI). Human umbilical cord subepithelial cell-derived stem cells (hUC-SECs), human bone marrow-derived mesenchymal stem cells (hBM-MSCs), and human induced pluripotent stem cell-derived cardiomyocytes (hiPSC-CMs), all derived from human tissue, have been shown to have in vitro and in vivo therapeutic potential. Additionally, S100a1, VEGF165, and stromal-derived factor-1α (SDF-1α) genes all have the potential to improve cardiac function and/or effect adverse remodeling. In this study, we compared the therapeutic potential of hBM-MSCs, hUC-SECs, and hiPSC-CMs along with plasmid-based genes to evaluate the in vivo potential of intramyocardially injected biologics to enhance cardiac function in a mouse MI model. Human cells derived from various tissue types were expanded under hypoxic conditions and injected intramyocardially into mice that had undergone left anterior descending (LAD) artery ligation. Similarly, plasmids were also injected into three groups of mice after LAD ligation. Seven experimental groups were studied in total: (1) control (saline), (2) hBM-MSCs, (3) hiPSC-CMs, (4) hUC-SECs, (5) S100a1 plasmid, (6) VEGF165 plasmid, and (7) SDF-1α plasmid. We evaluated echocardiography, hemodynamic catheterization measurements, and histology at 4 and 12 weeks post-biologic injection. Significant improvement was observed in cardiac function and contractility in hiPSC-CM and S100a1 groups and a significant reduction in left ventricle scar within the hUC-SEC group and a slight improvement in the SDF-1α and VEGF165 groups compared to the control group. These results demonstrate the potential for new biologic therapies to reduce scar burden and improve contractile function.

Trends and factors associated with the Day 5 embryo transfer, assisted reproductive technology surveillance, USA, 2001-2009.

STUDY QUESTION: What characteristics are associated with a Day 5 embryo transfer? SUMMARY ANSWER: The use of the Day 5 embryo transfer has increased over time, with clinicians allowing women with typically 'poorer' prognostic characteristics to undergo a Day 5 embryo transfer. The mean number of embryos per Day 5 transfer decreased from 2001 to 2009, although the prevalence of the Day 5 single embryo transfer remains low and the rate of multiple births remains substantial. WHAT IS KNOWN AND WHAT THIS PAPER ADDS: Day 5 embryo transfer may reduce the rate of multiple gestation pregnancy. US trends over time in the prevalence of the Day 5 transfer, changes in characteristics of patients receiving Day 5 transfer, and number of embryos transferred are unknown. DESIGN: We used 2001-2009 US National assisted reproductive technology (ART) Surveillance System (NASS) data on 620,295 fresh IVF cycles derived from autologous oocytes with a Day 3 or 5 embryo transfer. Trends in the mean number of embryos transferred from 2001 to 2009 were assessed by the day of transfer. For 349,947 cycles from clinics performing both Days 3 and 5 embryo transfers, multivariable logistic regression was used to determine the characteristics associated with the Day 5 embryo transfer. We also compared the characteristics of the Day 5 embryo cycles in 2001 and 2009. MAIN RESULTS AND THE ROLE OF CHANCE: Overall, the proportion of ART cycles using the Day 5 embryo transfer increased from 12% in 2001 to 36% in 2009 (P<0.0001), while the mean number of embryos transferred decreased from 2.4 to 2.1 (P<0.0001). Among Day 5 transfers, the rate of the single embryo transfer tripled from 4.5% in 2001 to 14.8% in 2009 (P<0.0001); and the rate of multiple births decreased from 44.8 to 41.1% (P<0.0001). In cycles initiated after 2001, maternal age<35 years, no prior ART cycles, ≥1 prior pregnancies, baseline follicle stimulating hormone<10 international units and ≥10 oocytes retrieved were associated with the Day 5 embryo transfer. Compared with 2001, in 2009, a broader range of candidates received the Day 5 transfer. BIAS Women undergoing multiple ART cycles over time are not linked. CONFOUNDING FACTORS AND OTHER REASONS FOR CAUTION: We ran multivariable logistic regression to lessen the effects of the confounding factors. Cycle cancelation rates by the day of embryo transfer are unknown. GENERALIZABILITY TO OTHER POPULATIONS: Generalizable to ART clinics included in NASS. STUDY FUNDING/COMPETING INTERESTS: This study was funded by the Centres for Disease Control. The authors have no competing interests to declare.

Effect of embryo transfer number on singleton and twin implantation pregnancy outcomes after assisted reproductive technology.

OBJECTIVE: To evaluate the effect of embryo transfer number on singleton and twin pregnancy outcomes with one and two fetal heartbeats on early ultrasound, respectively. STUDY DESIGN: The study included 23,645 singleton and 14,083 twin live births from the SART-CORS Online database of assisted reproductive technology cycles for 2004-2006. The data were limited to fresh embryo transfers among women who had additional embryos cryopreserved during the same cycle, resulting either in one fetal heartbeat on early ultrasound and a singleton live birth, or two fetal heartbeats and a twin live birth. Data were categorized by number of embryos transferred; the reference group was one for singletons and two for twins. The primary outcome measure was moderate growth restriction (birthweight for gestation z-score < -1), adjusted for potential confounders. RESULTS: Risk for moderate growth restriction among singletons was increased by 15%, 23%, and 37%, respectively, with 2, 3, and > or = 4 embryos transferred, and among twins, by 50% and 105%, respectively, with 3 and > or = 4 embryos transferred. CONCLUSION: The data demonstrate a significant residual adverse effect on intrauterine growth from transfer of multiple embryos. Whether this effect is due to compromised embryo quality, degenerating implantation sites, or other etiology is unclear.

Multivariate analysis of factors affecting probability of pregnancy and live birth with in vitro fertilization: an analysis of the Society for Assisted Reproductive Technology Clinic Outcomes Reporting System.

OBJECTIVE: To evaluate factors predictive of clinical pregnancy and of pregnancy loss from assisted reproductive technology (ART) using data from the Society for Assisted Reproductive Technology database for 2004-2006. DESIGN: Retrospective cohort. SETTING: Clinic-based data. PATIENT(S): The study population included 225,889 fresh embryo transfer cycles using autologous oocytes and partner semen. INTERVENTION(S): None. MAIN OUTCOME MEASURE(S): Clinical intrauterine gestation (presence of gestational sac) and live birth (>or=22 weeks gestation and >or=300 g birth weight). RESULT(S): Increasing maternal age was significantly associated with a reduced odds of conception and increased fetal loss until 19 weeks gestation, but not with later pregnancy loss. Intracytoplasmic sperm injection (ICSI), assisted hatching, and increasing number of embryos transferred had significant positive effects on the odds of conception and pregnancy continuation through the first trimester, but did not affect the risk of later loss. Blacks, Asians, and Hispanics had significantly lower odds of clinical pregnancy compared with whites. Also compared with whites, Hispanics and Asians had a significantly greater risk of pregnancy loss in the second and third trimesters, and blacks had a significantly greater risk of pregnancy loss in all trimesters. CONCLUSION(S): Certain demographic and ART treatment parameters influenced chance of conception and early pregnancy loss, whereas black race and Hispanic ethnicity were also significantly associated with late pregnancy loss in ART-conceived pregnancies.

Trends of racial disparities in assisted reproductive technology outcomes in black women compared with white women: Society for Assisted Reproductive Technology 1999 and 2000 vs. 2004-2006.

OBJECTIVE: To determine trends in assisted reproductive technology (ART) in black and white women by comparing Society for Assisted Reproductive Technology (SART) database outcomes for 2004-2006 with previously reported outcomes for 1999 and 2000. DESIGN: Retrospective, cohort study. SETTING: The SART member clinics that performed at least 50 cycles of IVF and reported race in more than 95% of cycles. PATIENT(S): Women receiving 158,693 IVF cycles. INTERVENTION(S): In vitro fertilization using nondonor embryos. MAIN OUTCOME MEASURE(S): Live birth rate per cycle started. RESULT(S): Reporting of race increased from 52% to 60%. The proportion of black, non-Hispanic (BNH) women increased from 4.6% to 6.5%. For BNH women using fresh embryos and no prior ART, significant increasing trends were observed for older age, male factor, uterine factor, diminished ovarian reserve, and ovulation disorders. The BNH women were 2.5 times more likely to have tubal factor for those cycles with no prior ART. The proportion of live births per cycle started increased across all groups over time, although greater increases occurred for white women. CONCLUSION(S): There seems to be widening disparities in IVF outcomes between BNH and white women, perhaps attributable to poor prognostic factors among black women. Race continues to be a marker for prognosis for ART outcomes and should be reported.

Practice patterns and outcomes with the use of single embryo transfer in the United States.

OBJECTIVE: To evaluate factors associated with the use of elective single embryo transfer (eSET) and its effect on assisted reproductive technology (ART) outcome. DESIGN: Historical cohort. SETTING: Clinic-based data. PATIENT(S): A total of 69,028 ART cycles of autologous fresh embryo transfers with additional embryos cryopreserved during the same cycle performed during 2004-06 and reported to the Society for Assisted Reproductive Technology Clinic Outcome Reporting System database. INTERVENTION(S): None. MAIN OUTCOME MEASURE(S): Factors associated with the number of embryos transferred, and the odds of pregnancy, live birth, and multiple-infant live birth by number of embryos transferred as adjusted odds ratios (AORs). RESULT(S): Single embryo transfer was used more with uterine factor (AOR 1.76) and less with male factor, endometriosis, or tubal factor (AOR 0.81, 0.72, 0.83, respectively). Compared with women aged <30 years, eSET was used less among women aged 35-39 years and > or =40 years (AOR 0.74 and 0.39, respectively). Compared with White women, eSET was used more with Asian (AOR 1.52) and less with Black or Hispanic women (AOR 0.73 and 0.67, respectively). Compared with eSET, the likelihood of pregnancy, live birth, or multiple-infant live birth was more likely with two embryos (AOR 1.33, 1.34, and 27.4, respectively). CONCLUSION(S): Elective SET, used more for younger women with specific diagnoses, is associated with slightly reduced likelihood of a live birth but much reduced likelihood of multiples.

Racial and ethnic disparities in assisted reproductive technology outcomes in the United States.

OBJECTIVE: To evaluate ethnic differences in assisted reproductive technology (ART) outcomes in the United States. DESIGN: Historical cohort study. SETTING: Clinic-based data. PATIENT(S): A total of 139,027 ART cycles from the Society for Assisted Reproductive Technology Clinic Outcome Reporting System online database for 2004-2006, limited to white, Asian, black, and Hispanic women. INTERVENTION(S): None. MAIN OUTCOME MEASURE(S): Logistic regression was used to model the odds of pregnancy and live birth; among singletons and twins, the odds of preterm birth and fetal growth restriction. Results are presented as adjusted odds ratios, with white women as the reference group. RESULT(S): The odds of pregnancy were reduced for Asians (0.86), and the odds of live birth were reduced for all groups: Asian (0.90), black (0.62), and Hispanic (0.87) women. Among singletons, moderate and severe growth restriction were increased for all infants in all three minority groups (Asians [1.78, 2.05]; blacks [1.81, 2.17]; Hispanics [1.36, 1.64]), and preterm birth was increased among black (1.79) and Hispanic women (1.22). Among twins, the odds for moderate growth restriction were increased for infants of Asian (1.30) and black women (1.97), and severe growth restriction was increased among black women (3.21). The odds of preterm birth were increased for blacks (1.64) and decreased for Asians (0.70). CONCLUSION(S): There are significant disparities in ART outcomes according to ethnicity.

The sex ratio of singleton offspring in assisted-conception pregnancies.

OBJECTIVE: To evaluate the effect of intracytoplasmic sperm injection (ICSI) and male factor infertility on the sex ratio in births from assisted reproductive technology. DESIGN: Historic cohort study. SETTING: Clinic-based data. PATIENT(S): The study population included 15,164 singleton live births in the Society for Assisted Reproductive Technology national database for 2005 from cycles using ejaculated sperm, categorized by the use of insemination or ICSI and the absence or presence of male factor infertility, and cleavage- versus blastocyst-stage embryo transfers (ETs). INTERVENTION(S): None. MAIN OUTCOME MEASURE(S): The probability of a male infant with and without the use of ICSI and in the presence or absence of male factor infertility. RESULT(S): The sex ratio for all U.S. live births in 2005 was 52.5%, versus 48.9% for cleavage-stage and 51.6% for blastocyst-stage embryos. With blastocyst-stage embryos, the sex ratios were 49.6% and 54.9% with and without ICSI and 52.6% and 50.0% with and without male factor infertility, respectively. With cleavage-stage embryos, the sex ratio was not significantly affected by ICSI or male factor infertility, singly or in combination. CONCLUSION(S): The use of ICSI, particularly with blastocyst-stage embryos, is associated with a decrease in the sex ratio of male infants.

The effect of early fetal losses on twin assisted-conception pregnancy outcomes.

OBJECTIVE: To evaluate the effect of first trimester fetal losses on twin births from assisted reproductive technology (ART). DESIGN: Historical cohort study. SETTING: Clinic-based data. PATIENT(S): The study population included 9,036 twin pregnancies of >or=22 weeks' gestation in the 2005 Society for Assisted Reproductive Technology Clinic Outcomes Reporting System database, categorized by the presence of three versus two fetal heartbeats on early ultrasound. INTERVENTION(S): None. MAIN OUTCOME MEASURE(S): Length of gestation and birthweight. Adjusted odds ratios (AORs) were calculated with the group with two fetal heartbeats on early ultrasound as the reference. RESULT(S): Increased odds with three fetal heartbeats included <32 weeks, 32-36 weeks, and <37 weeks (AORs 1.47, 1.28, and 1.35, respectively) and very low birthweight (<1,500 g), moderately low birthweight (1,500-2,499 g), and low birthweight (<2,500 g) (AORs 1.69, 1.38, and 1.47, respectively). Significantly decreased odds included term birth (>or=37 weeks) and nonlow birthweight (>or=2,500 g) (AORs 0.74 and 0.68). CONCLUSION(S): Early fetal loss in assisted-conception pregnancies that result in a twin live birth is associated with significantly increased risks for lowered birthweight and shortened gestation. Because first-trimester multiple fetal heartbeats are more common in ART pregnancies, this factor may help explain the greater risk for reduced birthweight and shorter gestations observed in this population.

The effect of early fetal losses on singleton assisted-conception pregnancy outcomes.

OBJECTIVE: To evaluate the effect of first trimester fetal losses in singleton births from assisted reproductive technology using data from the Society for Assisted Reproductive Technology national database for 2005. DESIGN: Historic cohort study. SETTING: Clinic-based data. PATIENT(S): The study population included 21,535 singleton deliveries of >or=22 weeks gestation categorized by the number of fetal heartbeats identified on early ultrasound as one, two, three, or more. INTERVENTION(S): None. MAIN OUTCOME MEASURE(S): Length of gestation, birthweight, and birthweight for gestation. Odds ratios (ORs) were calculated, with the group with one fetal heartbeat on early ultrasound as the reference. RESULT(S): Preterm birth (<37 weeks, OR 1.73; 32-36 weeks, OR 1.59; <32 weeks OR 2.56) and low birthweight (<2,500 g, OR 2.09; 1,500-2,499 g, OR 1.94) increased and term birth and nonlow birthweight decreased (OR 0.52 and 0.48) with more than one fetal heartbeat. CONCLUSION(S): Early fetal loss in pregnancies that result in a singleton live birth is associated with significantly increased odds for lowered birthweight, shortened gestation, and reduced birthweight for age. Because first trimester multiple fetal heartbeats are more common in assisted-conception pregnancies than in unassisted pregnancies, this factor may help explain the greater risk for reduced birthweight and shorter gestations observed in this population.

Male reproductive proteins and reproductive outcomes.

Male reproductive proteins (MRPs), associated with sperm and semen, are the moieties responsible for carrying male genes into the next generation. Evolutionary biologists have focused on their capacity to control conception. Immunologists have shown that MRPs cause female genital tract inflammation as preparatory for embryo implantation and placentation. These observations argue that MRPs are critically important to reproductive success. Yet the impact of male reproductive proteins on obstetrical outcomes in women is largely unstudied. Epidemiologic and clinical observations suggest that shorter-duration exposure to MRPs prior to conception may elevate the risk for preeclampsia. A limited literature has also linked sexual behavior to bacterial vaginosis and preterm birth. We offer a clinical opinion that MRPs may have broad implications for successful reproduction, potentially involved in the composition of vaginal microflora, risks of preterm birth and preeclampsia, and success of assisted reproduction.

Disparity in assisted reproductive technologies outcomes in black women compared with white women.

OBJECTIVE: To compare success rates in black and white women undergoing IVF. DESIGN: Retrospective cohort study. SETTING: Society for Assisted Reproductive Technology member clinics in 1999-2000 that performed >or=50 cycles of IVF and reported race/ethnicity in >95% of cycles. PATIENT(S): Women receiving 80,309 IVF cycles. INTERVENTION(S): IVF using nondonor embryos. MAIN OUTCOME MEASURE(S): Live-birth rate per cycle started. RESULT(S): Black, white, and other race/ethnicity women underwent 3666 (4.6%), 68,607 (83.5%), and 8036 (11.9%) IVF cycles, respectively. Spontaneous abortions were more common among black women. The live-birth rate was 26.3% (95% confidence interval [CI], 25.9%-26.7%) among white women compared with 18.7% (95% CI, 17.5%-20.1%) among black women (rate ratio, 1.41). After controlling for increased tubal and uterine factor infertility among blacks and other characteristics, black race was an independent risk factor for not achieving a live birth (adjusted relative risk, 1.21; 95% CI, 1.12-1.36 if no prior ART, and RR, 1.38; 95% CI, 1.20-1.57 if prior ART). For cryopreserved embryo cycles, live-birth rates were equivalent. CONCLUSION(S): Black women, who represented 7.8% of married reproductive-age women in the United States at that time, were underrepresented among IVF recipients. Race is a marker for prognosis that is not explained by characteristics available in the registry data set.

Assisted reproductive technology practice patterns and the impact of embryo transfer guidelines in the United States.

OBJECTIVE: [1] To evaluate trends in number of embryos transferred and resultant high-order multiple (HOM) pregnancy rates by Society for Assisted Reproductive Technology (SART)-member clinics between 1996 and 2003 and [2] to relate these practice patterns and outcomes to clinic compliance with SART-American Society for Reproductive Medicine (ASRM) embryo transfer guidelines. DESIGN: Retrospective. SETTING: Society for Assisted Reproductive Technology-member fertility centers in the United States. PATIENT(S): Five hundred thirty-six thousand, five hundred twenty-four fresh, nondonor IVF cycles. INTERVENTION(S): None. MAIN OUTCOME MEASURE(S): Number of embryos transferred; pregnancy rates; implantation rates; and proportion of singleton, twin, and HOM pregnancies. RESULT(S): The number of embryos transferred declined each year. High-order multiple pregnancy rates also declined, whereas the twin rates remained stable. The most pronounced declines in number transferred occurred immediately after publication of SART-ASRM embryo transfer guidelines. After stratifying clinics according to mean and modal number of embryos transferred, clinics transferring the fewest embryos in women <35 years of age had the highest mean implantation and pregnancy rates. Furthermore, the percentage of clinics transferring two embryos to a majority of women <35 years of age increased from 3.3% in 1996 to 49.9% in 2003. CONCLUSION(S): The implementation of SART-ASRM embryo transfer guidelines is associated with significant reductions in the number of embryos being transferred, along with reductions of HOM pregnancies. Initiatives to further reduce twin pregnancies and encourage singleton gestation outcomes are outlined.

Use of a gestational carrier for a patient with recurrent adverse pregnancy outcomes from early onset severe pre-eclampsia.

OBJECTIVE: To describe the first reported case of gestational carrier treatment to prevent severe early onset pre-eclampsia. DESIGN: Case report. SETTING: A university-based reproductive endocrinology and infertility clinic and a tertiary care hospital. PATIENT(S): A 29-year-old woman and her husband with three consecutive pregnancies complicated by early onset severe pre-eclampsia causing fetal demises at 22 and 24 weeks gestation; a neonatal death at 25 weeks gestation; and life-threatening maternal hemolysis, elevated liver enzymes, and low platelets. INTERVENTION(S): An IVF procedure in the patient using her husband's sperm with the transfer of two embryos to a friend who offered to be a gestational carrier. MAIN OUTCOME MEASURE(S): Successful IVF cycle in the patient and uncomplicated pregnancy and delivery in the gestational carrier. RESULT(S): The gestational carrier achieved a pregnancy and progressed without complications to delivery of a healthy, 3.2-kg infant at 39 weeks gestation. CONCLUSION(S): The use of a gestational carrier deserves consideration as a treatment option in patients with poor reproductive histories because of early onset severe pre-eclampsia and hemolysis, elevated liver enzymes, and low platelets syndrome. This experience also suggests that development of pre-eclampsia may be in large part maternally rather than embryologically or paternally driven.