29 research outputs found
Risk of pregnancy and external validity in clinical trials of emergency contraception.
OBJECTIVES: To compare women who enroll in emergency contraception (EC) trials to those who decline and to understand why eligible women decline to participate. METHODS: Data were collected from all women seeking EC (n = 5,787) at three clinics in the USA and UK during a period of nearly 1 year (from September 1997 to August 1998). The main outcome measures were pregnancy risk calculated by adjusted cycle day of ovulation. RESULTS: Enrolled and non-enrolled women had similar mean ages and similar mean cycle lengths. However, the enrolled and non-enrolled groups were different with respect to adjusted cycle day of unprotected sexual intercourse (UPSI), the regularity of their cycles, recent hormone use, breastfeeding, the number of other acts of UPSI they had engaged in during the same cycle, and their willingness to participate in the study. Expected pregnancy risk among enrolled patients was higher than among non-enrolled EC seekers (6.5% vs 5.0%, p<0.001, calculated using Dixon conception probabilities, and 5.4% vs 4.6%, p = 0.086, calculated using Trussell conception probabilities). Unwillingness to take part in the study was the most common reason women did not enrol in the trial. Otherwise-eligible women most often declined to enrol because they were concerned about the effectiveness of the trial regimen. CONCLUSIONS: Women in EC trials are likely to face higher pregnancy risk than the general population. Clinical trials might overestimate the number of pregnancies averted by treatment because the number of expected pregnancies in trial populations is not representative of the population of all EC seekers. This information could be useful in projecting the public health impact of expanded EC access
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Association between testosterone, semen parameters, and live birth in men with unexplained infertility in an intrauterine insemination population
To determine whether men with unexplained infertility and low total T (TT) have abnormal spermatogenesis and lower fecundity.
Secondary analysis of the prospective, randomized, multicenter clinical trial, Assessment of Multiple Intrauterine Gestations from Ovarian Stimulation (AMIGOS).
Infertility clinics.
Nine hundred couples with unexplained infertility enrolled in AMIGOS. Semen analysis with an ejaculate of at least 5 million total motile sperm was required for enrollment. For inclusion in this secondary analysis, a fasting TT was required.
None.
Logistic regression, adjusted for age and body mass index, assessed the association between low TT (defined as <264 ng/dL), semen parameters, and pregnancy outcome.
Seven hundred eighty-one men (mean age, 34.2 ± 5.7 years) with a median (interquartile range) TT of 411 (318–520) ng/dL were included. Men with TT 264 ng/dL. The odds of live birth decreased by 40% in couples whose male partner had low TT (unadjusted OR, 0.60; 95% CI, 0.36, 1.00; adjusted OR, 0.65; 95% CI, 0.38, 1.12).
In couples with unexplained infertility, low TT in the male partner was associated with abnormal sperm morphology and lower live birth rates.
NCT01044862.
Asociación entre la testosterona, los parámetros seminales, y los nacidos vivos en hombres con infertilidad inexplicable en una población de inseminación intrauterina
Determinar si los hombres con infertilidad inexplicable y testosterona total (TT) baja tienen espermatogénesis anormal y menor fecundidad.
Análisis secundario del ensayo clínico prospectivo, aleatorizado, multicéntrico, Evaluación de Gestaciones Intrauterinas Múltiples a partir de Estimulación Ovárica (AMIGOS).
Clínicas de infertilidad.
Novecientas parejas con infertilidad inexplicada inscritas en AMIGOS. Análisis de semen con una eyaculación con al menos 5 millones de espermatozoides móviles totales para la participación en el estudio. Para su inclusión en este análisis secundario, se requirió una muestra en ayunas de TT.
Ninguna.
Regresión logística, ajustada por edad e índice de masa corporal, evaluando la asociación entre TT baja (definido como <264 ng/dL), parámetros del semen y resultado del embarazo.
Se incluyeron setecientos ochenta y un hombres (edad media, 34.2 ± 5.7 años) con una mediana (rango intercuartil) de TT de 411 (318–520) ng / dL. Los hombres con TT 264 ng/dL. Las probabilidades de nacidos vivos disminuyeron en un 40% en las parejas cuyo compañero masculino tenía TT baja (OR no ajustada, 0.60; IC del 95%, 0.36; 1.00; OR ajustada, 0.65; IC del 95%, 0.38; 1.12).
En parejas con infertilidad inexplicable, la TT baja en la pareja masculina se asoció con una morfología anormal de los espermatozoides y menores tasas de nacidos vivos