NCT03395067

Brief Summary

The aim of the present study is to evaluate the impact of a multidisciplinary treatment of obesity prior to IVF on global reproductive outcomes and maternofetal metabolic and cardiovascular risk factors. This is a randomized controlled trial in obese infertile women before starting an IVF cycle. The intervention is based on a structured multidisciplinary program in support groups, which includes diet, physical activity and psychological therapy. IVF will be started immediately after this therapy. Patients included in the control group will start an IVF cycle immediately after the randomization. The results of this study may allow the identification of patients who would benefit from obesity treatment, so as to establish appropriate preventive and therapeutic strategies and to reduce the maternal obesity impact in future generations.

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
104

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable obesity

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

December 17, 2017

Completed
24 days until next milestone

First Posted

Study publicly available on registry

January 10, 2018

Completed
18 days until next milestone

Study Start

First participant enrolled

January 28, 2018

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

January 30, 2018

Status Verified

January 1, 2018

Enrollment Period

2.8 years

First QC Date

December 17, 2017

Last Update Submit

January 28, 2018

Conditions

ObesityInfertility

Keywords

ObesityInfertilityIn vitro fertilization

Outcome Measures

Primary Outcomes (1)

  • live birth rate of a healthy baby in a non-complicated pregnancy

    live birth rate in a pregnancy without major complications: gestational diabetes, hypertensive disorders, preterm delivery, congenital anomalies, stillbirth, neonatal death, shoulder dystocia, maternal venous thromboembolism, fetal growth abnormal outcomes (macrosomia, large for gestational age, intrauterine growth restriction)

    10 months after starting the IVF treatment

Secondary Outcomes (21)

  • anthropometric parameters: weight (kilograms)

    4 months after starting the intervention

  • anthropometric parameters: body mass index - BMI (kilograms/metro2)

    4 months after starting the intervention

  • anthropometric parameters: abdominal circumference (centimeters)

    4 months after starting the intervention

  • hormonal parameters: antimullerian hormone (AMH)

    2 years (simultaneous analysis of all the biological samples)

  • hormonal parameters: insulin

    2 years (simultaneous analysis of all the biological samples)

  • +16 more secondary outcomes

Study Arms (2)

Lifestyle counseling

ACTIVE COMPARATOR
Behavioral: Intervention group

Control group

NO INTERVENTION

Interventions

Intervention groupBEHAVIORAL

Lifestyle counseling coupled with psychotherapeutical intervention

Lifestyle counseling

Eligibility Criteria

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

You may qualify if:

  • Obese infertile patients (body mass index ≥ 30 Kg/m2) prior to an in vitro fertilization cycle

You may not qualify if:

  • Pathological conditions: diabetes type I, Cushing syndrome, premature ovarian failure, uncontrolled thyroidal dysfunction, hepatic and/or renal dysfunction, antiphospholipid syndrome, medical condition that contraindicate ovarian stimulation and/or pregnancy
  • Simultaneous practice of another strategy to lose weight
  • Physical conditions limiting exercise training
  • Patients unable to understand spanish language or to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clínic de Barcelona

Barcelona, 08036, Spain

RECRUITING

MeSH Terms

Conditions

ObesityInfertility

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGenital DiseasesUrogenital Diseases

Study Officials

  • Gemma Casals

    Hospital Clinic of Barcelona

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gemma Casals

CONTACT

0034932275744gcasals@clinic.cat

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trial including 2 arms: intervention group and control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 17, 2017

First Posted

January 10, 2018

Study Start

January 28, 2018

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

January 30, 2018

Record last verified: 2018-01

Locations

ES(1)