NCT02648555

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 7, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

January 7, 2016

Status Verified

January 1, 2016

Enrollment Period

2 years

First QC Date

January 4, 2016

Last Update Submit

January 6, 2016

Conditions

SterilityPlacenta; ImplantationRisk Reduction BehaviorLifestyleNeonatal Hypoglycemia

Outcome Measures

Primary Outcomes (1)

  • The rate of viable pregnancies

    two years

Secondary Outcomes (10)

  • The rate of fist trimester losses

    four years

  • The rate of second and third trimester losses

    four years

  • The rate of preeclampsia, eclampsia and HELLP syndrome

    four years

  • Cramps or bleeding during the first trimester requiring progesterone

    four years

  • The rate of prematurity

    four years

  • +5 more secondary outcomes

Study Arms (2)

Standard follow-up (controls)

NO INTERVENTION

Given that depressive disorders may increase the risk of spontaneous abortions, antidepressants will be not discontinued. However, expectant mothers on paroxetine or sertraline, which have been reported to increase the incidence of cardiac malformations, will be switched to fluoxetine.

W+D protocol (lifestyle intervention)

EXPERIMENTAL

Daily walking and dietary recommendations. Expectant mothers on paroxetine or sertraline will be switched to fluoxetine

Behavioral: Daily walkingBehavioral: Dietary recommendations

Interventions

Daily walkingBEHAVIORAL

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

W+D protocol (lifestyle intervention)
Dietary recommendationsBEHAVIORAL

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.

W+D protocol (lifestyle intervention)

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • women undergoing assisted reproduction

You may not qualify if:

  • liver failure, kidney failure or other conditions that prevent the patient from eating proteins.
  • multiple pregnancy.
  • paraplegia, hemiplegia, arthropathy and other conditions that prevent the participant from exercising.
  • participants lost to follow-up.
  • conditions that may strongly affect pregnancy results, such as a serious accident
  • participants assigned to non-intervention group following the recommendations given to intervention group.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Federal dos Servidores do Estado, Ministry of Health

Rio de Janeiro, Rio de Janeiro, 20221-903, Brazil

Location

MeSH Terms

Conditions

InfertilityRisk Reduction Behavior

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesBehavior

Study Officials

  • Silvia Hoirisch-Clapauch, MD, PhD

    Hospital Federal dos Servidores do Estado, Ministry of Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Silvia Hoirisch-Clapauch, MD, PhD

CONTACT

+55-21-999737500sclapauch@ig.com.br

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

January 4, 2016

First Posted

January 7, 2016

Study Start

May 1, 2016

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

January 7, 2016

Record last verified: 2016-01

Locations

BR(1)