Lifestyle Clinical Trial
Official title:
A Lifestyle Intervention to Improve in Vitro Fertilization Results
Embryo adhesion and placentation depend on tissue plasminogen activator (tPA)-mediated
activation of brain-derived neurotrophic factor, vascular endothelial growth factor and
other growth factors, formation of hemidesmosomes, and degradation of extracellular matrix
and basement membrane, either directly or by activating matrix metalloproteinases.
Since glucose and insulin stimulate release of a major tPA inhibitor by endothelial cells -
plasminogen activator inhibitor (PAI)-1 - the investigators hypothesized that lifestyle
interventions proven effective in maintaining glucose and insulin levels within the normal
range would increase the take home baby rate in women undergoing assisted reproduction.
Tissue plasminogen activator (tPA) has a well-known role in the coagulation pathway. tPA
converts plasminogen to plasmin. Plasmin dissolves fibrin clots, thus limiting thrombus
formation to the site of vascular injury.
In the extravascular compartment, tPA is a pivotal mediator of tissue formation and
remodeling. Due to its proteolytic activity, tPA participates in processes as diverse as
embryo adhesion, placental angiogenesis and vasculogenesis, and neuronal plasticity. Embryo
adhesion and placentation, for example, depend on tPA-mediated activation of brain-derived
neurotrophic factor, vascular endothelial growth factor and other growth factors, formation
of hemidesmosomes, and degradation of extracellular matrix and basement membrane, either
directly or by activating matrix metalloproteinases.
Assuming low tPA activity would impair both blood clot dissolution and placentation, the
investigators postulated that patients with consecutive first-trimester abortions would have
a high prevalence of severe dysmenorrhea, accompanied by the passage of large clots.
In 2011, the investigators assessed the prevalence of severe dysmenorrhea during early
adolescence in two groups. The first one was made of women with ≥ 2 consecutive
first-trimester abortions, and the other, of women with ≥ 2 living births, and no losses or
preterm deliveries. Severe dysmenorrhea was defined as suprapubic menstrual cramp, intense
enough to cause repeated absenteeism from school or fainting in the absence of analgesia.
Early adolescents are unlikely to use contraceptives, or to have become pregnant, two
situations that may reduce the pain. In this study, severe dysmenorrhea increased the
chances of having consecutive first-trimester miscarriages by sevenfold (95% Confidence
Interval: 3.4 to 14.1; p<0.001).
Since glucose and insulin stimulate release of a major tPA inhibitor by endothelial cells -
plasminogen activator inhibitor (PAI)-1 - the investigators hypothesized that lifestyle
interventions proven effective in maintaining glucose and insulin levels within the normal
range would increase the take home baby rate in women undergoing assisted reproduction.
The protocol has already been tested at a Brazilian tertiary care center in women with
unexplained consecutive first-trimester abortions, conceiving spontaneously. The objective
of this study was to observe the impact of lifestyle interventions on the take home baby
rate, and to observe if the intervention could reduce the prevalence of preeclampsia and
neonatal hypoglycemia.
From 2011 to 2015, 480 patients aged 18 to 42 years with ≥ 2 consecutive first-trimester
abortions documented by pathology or ultrasonography, were randomly assigned to protocol
Walking and Diet (W+D) or to standard follow-up (controls). Women were enrolled independent
of having had severe dysmenorrhea during adolescence. Patients assigned to protocol W+D were
instructed to walk briskly for ≥ 40 minutes seven days a week. In addition, they were
recommended to avoid high-carbohydrate meals such as snacks, candies, fiber-free juices,
coconut water and sugar-sweetened beverages, and to eat two daily servings of meat, poultry,
fish (e.g. 2 g/kg) or other protein-rich food, starting when they decided to get pregnant
and continuing until delivery. Women with antiphospholipid antibodies, second- or
third-trimester losses, multiple pregnancies, anatomical abnormalities that could increase
the risk of first-trimester abortions, or any condition requiring a priori anticoagulation
were excluded.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
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