Lifestyle Clinical Trial
— W+DOfficial 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.
Status | Not yet recruiting |
Enrollment | 240 |
Est. completion date | May 2018 |
Est. primary completion date | May 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility |
Inclusion Criteria: - women undergoing assisted reproduction Exclusion Criteria: 1. liver failure, kidney failure or other conditions that prevent the patient from eating proteins. 2. multiple pregnancy. 3. paraplegia, hemiplegia, arthropathy and other conditions that prevent the participant from exercising. 4. participants lost to follow-up. 5. conditions that may strongly affect pregnancy results, such as a serious accident 6. participants assigned to non-intervention group following the recommendations given to intervention group. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Brazil | Hospital Federal dos Servidores do Estado, Ministry of Health | Rio de Janeiro | RJ |
Lead Sponsor | Collaborator |
---|---|
Hospital dos Servidores do Estado do Rio de Janeiro | Hospital Universitário Gaffrée Guinle |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The rate of viable pregnancies | two years | No | |
Secondary | The rate of fist trimester losses | four years | No | |
Secondary | The rate of second and third trimester losses | four years | No | |
Secondary | The rate of preeclampsia, eclampsia and HELLP syndrome | four years | No | |
Secondary | Cramps or bleeding during the first trimester requiring progesterone | four years | No | |
Secondary | The rate of prematurity | four years | No | |
Secondary | The rate of intrauterine growth restriction | four years | No | |
Secondary | Maternal weight gain | four years | No | |
Secondary | The rate of gestational diabetes | four years | No | |
Secondary | The rate of neonatal hypoglycemia | four years | No | |
Secondary | The rate of neonatal hyperbilirubinemia requiring phototherapy | four years | No |
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