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SterilityW+DNCT02648555

A Lifestyle Intervention to Improve in Vitro Fertilization Results

A study testing Daily walking and Dietary recommendations in people with Sterility and Placenta; Implantation, run by Hospital dos Servidores do Estado do Rio de Janeiro at 1 site in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 40 years, women onlyHealthy volunteers can take part
What is being tested?
Daily walking and Dietary recommendations
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
1 siteBrazil
Study dates
May 2016to May 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • women undergoing assisted reproduction

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Silvia Hoirisch-Clapauch, MD, PhD contact

+55-21-999737500

sclapauch@ig.com.br

Brazil1 site
  • Hospital Federal dos Servidores do Estado, Ministry of Health

    Rio de Janeiro, Rio de Janeiro, 20221-903

    Silvia Hoirisch-Clapauch, MD, PhD, +55-21-99973-7500, sclapauch@ig.com.br

    Silvia Hoirisch-Clapauch, MD

Other trials in Brazil

About this study

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.

Read the detailed description

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.

Being tested
Daily walking, Dietary recommendations
Medical subject headings
Infertility, Risk Reduction Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Daily walkingBehavioural

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

  • Dietary recommendationsBehavioural

    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.

Study groups in NCT02648555
Study groupRoleWhat they receive
Standard follow-up (controls)No interventionGiven 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)ExperimentalDaily walking and dietary recommendations. Expectant mothers on paroxetine or sertraline will be switched to fluoxetine
Receives: Behavioral: Daily walking; Behavioral: Dietary recommendations

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The rate of viable pregnancies

    Measured: two years

Secondary outcomes (10)
  1. The rate of fist trimester losses

    Measured: four years

  2. The rate of second and third trimester losses

    Measured: four years

  3. The rate of preeclampsia, eclampsia and HELLP syndrome

    Measured: four years

  4. Cramps or bleeding during the first trimester requiring progesterone

    Measured: four years

  5. The rate of prematurity

    Measured: four years

  6. The rate of intrauterine growth restriction

    Measured: four years

  7. Maternal weight gain

    Measured: four years

  8. The rate of gestational diabetes

    Measured: four years

  9. The rate of neonatal hypoglycemia

    Measured: four years

  10. The rate of neonatal hyperbilirubinemia requiring phototherapy

    Measured: four years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jan 2016 (estimated)
  2. Study startMay 2016
  3. Primary completionMay 2018 (estimated)
  4. Study completionMay 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02648555
Sponsor's protocol ID
Protocol W+D
Acronym
W+D
Status last verified
Jan 2016
First submitted
4 Jan 2016
Last updated
7 Jan 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Daily walking and Dietary recommendations in people with Sterility and Placenta; Implantation, run by Hospital dos Servidores do Estado do Rio de Janeiro at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Silvia Hoirisch-Clapauch, MD, PhD (+55-21-999737500, sclapauch@ig.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The rate of viable pregnancies (time frame: two years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2016.

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