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A Lifestyle Intervention to Improve in Vitro Fertilization Results

NCT02648555 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2016-01-07

No results posted yet for this study

Summary

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.

Conditions

  • Sterility
  • Placenta; Implantation
  • Risk Reduction Behavior
  • Lifestyle
  • Neonatal Hypoglycemia

Interventions

BEHAVIORAL

Daily walking

Participants will be instructed to walk briskly for \>40 minutes, 7 days a week.

BEHAVIORAL

Dietary recommendations

Participants will be instructed to eat at least two daily servings of meat, poultry, fish (e.g. 2 g/kg) or other protein-rich food, starting at least one week before embryo transfer and continuing until delivery. They will be also recommended to avoid high-glycemic index meals (high-carbohydrate, low-fiber), such as snacks, candies, fiber-free juices, coconut water, and sugar-sweetened beverages, particularly carbonated soft drinks and sport drinks. Patients suffering from nausea usually do not tolerate solid food. As a result, fiber-free juices and sugar-sweetened beverages account of most of their caloric intake, which may cause non-adherence to the protocol. Women with nausea or vomiting will be treated with ondansetron.

Sponsors & Collaborators

  • Gaffree & Guinle Universitary Hospital

    collaborator OTHER

  • Hospital dos Servidores do Estado do Rio de Janeiro

    lead OTHER_GOV

Principal Investigators

  • Silvia Hoirisch-Clapauch, MD, PhD · Hospital Federal dos Servidores do Estado, Ministry of Health

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2018-05-31
Completion
2018-05-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02648555 on ClinicalTrials.gov