ABSTRACT
OBJECTIVE: To compare the results of two ovarian stimulation protocols for IVF in patients at risk of poor ovarian response: corifollitropin alfa followed by hp-hMG versus daily administration of hp-hMG. We intended to demonstrate the non-inferiority of the protocol with corifollitropin alfa. STUDY DESIGN: This is a prospective, randomized, non-inferiority, controlled study. We compared two ovarian stimulation protocols for IVF in 234 patients, under 40 years of age and at risk of poor ovarian response. First protocol was a single injection of 150 µg corifollitropin alfa and the second, a daily injection of 300 IU of hp-hMG during the first week of ovarian stimulation. In both groups, if necessary, a daily injection of 300 IU of hp-hMG was dispensed until the criteria for hCG administration are met. For the primary and secondary outcomes, results were analysed by using a one-sided chi-square test or a Fisher exact test, as appropriate, with a level of significance of 0.05. For continuous variables, parametric (independent t-test) or non-parametric (Mann-Whitney test) tests were used depending on the normality of the distribution. Statistical significance was set at P < 0.05. RESULTS: The ongoing pregnancy rate, live birth rate (15.2 vs 20.2) (P = 0.33), and the cumulative live birth rate (15.2 vs 22.0) (P = 0.19) per started cycle did not show significant differences between the corifollitropin alfa and hp-hMG groups, and the difference estimated between treatments was -5% [95% CI: (-15.1, 5.0)]. CONCLUSIONS: It was not possible to probe non-inferiority of the protocol with corifollitropin alfa followed by hp-hMG compared to hp-hMG in patients at risk of poor ovarian response undergoing ICSI.
Subject(s)
Fertility Agents, Female/administration & dosage , Follicle Stimulating Hormone, Human/administration & dosage , Menotropins/administration & dosage , Ovulation Induction/methods , Sperm Injections, Intracytoplasmic/methods , Adult , Birth Rate , Female , Humans , Pregnancy , Pregnancy Rate , Prospective StudiesABSTRACT
It is not yet known whether Yasmin involves a higher thrombotic risk compared with other contraceptives. We present a serie of eight new cases of women who developed thrombotic events early after starting on Yasmin who were sent to our Thrombosis and Hemostasis Unit for a thrombophilia work-up in the last five years. Only two of them were heterozygous carriers of the prothrombin G20210A mutation and three were obese while none of them were smoker. These new cases provide information about the characteristics of the thrombotic events and the concomitant risk factors, indicating that this pill may not be as safe as had been previously thought, and suggest that new studies regarding safety profile of Yasmin are required to explain the association with venous thrombotic events.
Subject(s)
Androstenes/adverse effects , Contraceptives, Oral, Combined/adverse effects , Ethinyl Estradiol/adverse effects , Venous Thromboembolism/chemically induced , Adult , Female , Genetic Predisposition to Disease , Humans , Prothrombin/genetics , Risk Factors , Young AdultABSTRACT
INTRODUCTION AND OBJECTIVES: Cardiac troponins are highly specific and sensitive for detecting minimal myocardial damage. The aim of our study was to determine the prognostic value of troponin T levels in patients hospitalized for suspected angina or myocardial infarction without ST-segment elevation. PATIENTS AND METHOD: We recorded the frequency of death, acute myocardial infarction, heart failure, or need for coronary revascularization in the three months after the onset of symptoms in 346 consecutive patients admitted for suspected acute coronary syndrome, excluding those who developed myocardial infarction with persistent ST-segment elevation. RESULT: . Serum troponin T levels were > or = 0.1 ng/ml in 133 patients (troponin T positive group) and lower in 213 patients (troponin T negative group). The relative risk (RR) and 95 percent confidence intervals (95% CI) of individual and grouped events for the troponin T positive group were 3.2 (95% CI, 1.4-7.3; p = 0.006) for death; 2.8 (95% CI, 1.43-5.51; p = 0.003) for death or myocardial infarction; and 2.8 (95% CI, 1.6-5.0; p < 0.001) for death, myocardial infarction or heart failure. Diabetes mellitus and troponin T levels > or = 0.1 ng/ml had independent prognostic value after adjusting for age, sex, and electrocardiographic changes; with RR 2.5 (95% CI, 1.01-5.9) for death, myocardial infarction or heart failure. CONCLUSIONS: The prognosis of patients hospitalized for chest pain who do not immediately develop transmural necrosis depends on serum troponin T levels at hospital admission. Troponin T levels > or = 0.1 ng/ml almost triple the risk of major events in the three months after the acute episode. The prognostic value of troponin T is independent of age, sex, presence of diabetes mellitus, and electrocardiographic changes.
Subject(s)
Angina, Unstable/diagnosis , Myocardial Infarction/diagnosis , Troponin T , Adult , Aged , Aged, 80 and over , Angina, Unstable/blood , Biomarkers/blood , Electrocardiography , Female , Hospitalization , Humans , Male , Middle Aged , Myocardial Infarction/blood , Prognosis , Retrospective Studies , Troponin T/bloodABSTRACT
Introducción y objetivos. Las troponinas son proteínas estructurales cardioespecíficas con elevadas sensibilidad y especificidad en la detección de daño miocárdico. Nuestro propósito ha sido conocer el valor pronóstico de la determinación de troponina T en pacientes ingresados por sospecha de angina inestable o infarto sin elevación del segmento ST. Pacientes y método. Determinamos la aparición de muerte, infarto agudo de miocardio, insuficiencia cardíaca o necesidad de revascularización en los 3 meses siguientes al inicio de los síntomas en 346 pacientes consecutivos ingresados por sospecha de síndrome coronario agudo, entre los que se excluyó a aquellos que desarrollaron infarto agudo de miocardio con elevación persistente del segmento ST. Resultados. Las concentraciones de troponina T fueron 0,1 ng/ml en 133 pacientes (grupo troponina T positivo) e inferiores en 213 (grupo troponina T negativo). Los riesgos relativos (RR), con sus intervalos de confianza del 95 per cent (IC del 95 per cent) para los sucesos individuales y agrupados en el grupo troponina T positivo completo fueron: 3,2 (IC del 95 per cent, 1,4-7,3; p = 0,006) para riesgo de muerte; 2,8 (IC del 95 per cent, 1,43-5,51; p = 0,003) para muerte o infarto, y 2,8 (IC del 95 per cent, 1,6-5,0; p < 0,001) para muerte, infarto o insuficiencia cardíaca. Junto con la diabetes mellitus, los valores de troponina T 0,1 ng/ml mantienen un valor pronóstico independiente al efectuar el ajuste para edad, sexo y cambios en el ECG inicial, con RR = 2,5 (IC del 95 per cent, 1,01-5,9) para muerte, infarto o insuficiencia cardíaca. Conclusiones. Los pacientes que ingresan por sospecha de síndrome coronario agudo y no evolucionan inmediatamente a infarto transmural presentan un pronóstico distinto según los valores de troponina T en el momento del ingreso, más adverso con la presencia de valores elevados. De modo que cifras 0,1 ng/ml casi triplican el riesgo de acontecimientos mayores durante los 3 meses posteriores al episodio anginoso agudo. El valor pronóstico de los valores plasmáticos de troponina T es independiente de la edad, el sexo, la presencia de diabetes mellitus y los hallazgos electrocardiográficos (AU)
