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Multidisciplinary Treatment of Obesity Prior to in Vitro Fertilization: Impact on Global Reproductive Outcomes (PRO-FIV Study) (PRO-FIV)

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ClinicalTrials.gov Identifier: NCT03395067
Recruitment Status : Recruiting
First Posted : January 10, 2018
Last Update Posted : January 30, 2018
Sponsor:
Information provided by (Responsible Party):
Gemma Casals i Soler, Hospital Clinic of Barcelona

Tracking Information
First Submitted Date  ICMJE December 17, 2017
First Posted Date  ICMJE January 10, 2018
Last Update Posted Date January 30, 2018
Estimated Study Start Date  ICMJE January 28, 2018
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 8, 2018)
live birth rate of a healthy baby in a non-complicated pregnancy [ Time Frame: 10 months after starting the IVF treatment ]
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 8, 2018)
  • anthropometric parameters: weight (kilograms) [ Time Frame: 4 months after starting the intervention ]
    weight change during intervention, measured in kilograms
  • anthropometric parameters: body mass index - BMI (kilograms/metro2) [ Time Frame: 4 months after starting the intervention ]
    BMI change during intervention, measured as kilograms/metro2
  • anthropometric parameters: abdominal circumference (centimeters) [ Time Frame: 4 months after starting the intervention ]
    abdominal circumference change during intervention measured in centimeters
  • hormonal parameters: antimullerian hormone (AMH) [ Time Frame: 2 years (simultaneous analysis of all the biological samples) ]
    AMH serum levels before the intervention (intervention group) and before the IVF (2 arms)
  • hormonal parameters: insulin [ Time Frame: 2 years (simultaneous analysis of all the biological samples) ]
    insulin serum levels before the intervention (intervention group) and before the IVF (2 arms)
  • hormonal parameters: leptin [ Time Frame: 2 years (simultaneous analysis of all the biological samples) ]
    leptin serum levels before the intervention (intervention group) and before the IVF (2 arms)
  • hormonal parameters: adiponectin [ Time Frame: 2 years (simultaneous analysis of all the biological samples) ]
    adiponectin serum levels before the intervention (intervention group) and before the IVF (2 arms)
  • hormonal parameters: ghrelin [ Time Frame: 2 years (simultaneous analysis of all the biological samples) ]
    ghrelin serum levels before the intervention (intervention group) and before the IVF (2 arms)
  • IVF outcomes: cycle cancellation rate [ Time Frame: 3 months after starting IVF cycle ]
    cycle cancellation rate: cancelled cycles/ initiated cycles
  • IVF outcomes: gonadotropin doses (UI) [ Time Frame: 3 months after starting IVF cycle ]
    total gonadotropin doses used in the IVF stimulation protocol
  • IVF outcomes: number of oocytes [ Time Frame: 3 months after starting IVF cycle ]
    number of oocytes retrieved
  • IVF outcomes: number of embryos [ Time Frame: 3 months after starting IVF cycle ]
    total number of embryos obtained in 2 pronuclear stage
  • IVF outcomes: number of good quality embryos [ Time Frame: 3 months after starting IVF cycle ]
    number of good quality embryos (type A and B) obtained in the cleavage stage
  • IVF outcomes: clinical pregnancy rate [ Time Frame: 3 months after starting IVF cycle ]
    clinical pregnancy rate: clinical pregnancies/started cycles
  • IVF outcomes: miscarriage rate [ Time Frame: 3 months after starting IVF cycle ]
    miscarriage rate: miscarriages/clinical pregnancies
  • fetal ultrasound [ Time Frame: 26-30 weeks after confirmation of pregnancy ]
    fetal ultrasound and Doppler parameters at 28-32 weeks of gestation. All parameters are measured according to the current guidelines and reported as quantitative measurements.
  • postpartum anthropometric outcomes: maternal abdominal circumference (centimeters) [ Time Frame: 12 months after the delivery ]
    Maternal abdominal circumference in centimeters 1 month and 12 months after the delivery
  • postpartum anthropometric outcomes: maternal weight (kilograms) [ Time Frame: 12 months after the delivery ]
    Maternal weight in kilograms 1 month and 12 months after the delivery
  • postpartum anthropometric outcomes: neonatal weight (grams) [ Time Frame: 12 months after the delivery ]
    neonatal weight in grams 1 month and 12 months after the delivery
  • postpartum anthropometric outcomes: neonatal height (centimeters) [ Time Frame: 12 months after the delivery ]
    neonatal height in centimeters 1 month and 12 months after the delivery
  • postpartum anthropometric outcomes: neonatal skin fold measurements (millimeters) [ Time Frame: 12 months after the delivery ]
    neonatal skin fold measurements in millimeters 1 month and 12 months after the delivery
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Multidisciplinary Treatment of Obesity Prior to in Vitro Fertilization: Impact on Global Reproductive Outcomes (PRO-FIV Study)
Official Title  ICMJE Multidisciplinary Treatment of Obesity Prior to In Vitro Fertilization: Impact on Global Reproductive Outcomes
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.

Detailed Description

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 (body mass index ≥30 kg/m2) before starting an IVF cycle. In the intervention group, the aim is a weight loss of at least 10% in a 16-week period of treatment based on a multidisciplinary approach and support groups, which includes diet, physical activity and psychological therapy. IVF will be started immediately after this period. 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized controlled trial including 2 arms: intervention group and control group.
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Obesity
  • Infertility
Intervention  ICMJE Behavioral: Intervention group
Lifestyle counseling coupled with psychotherapeutical intervention
Study Arms  ICMJE
  • Active Comparator: Lifestyle counseling
    Intervention: Behavioral: Intervention group
  • No Intervention: Control group
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 8, 2018)
104
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Gemma Casals 0034932275744 gcasals@clinic.cat
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03395067
Other Study ID Numbers  ICMJE HCB/2017/0730
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gemma Casals i Soler, Hospital Clinic of Barcelona
Study Sponsor  ICMJE Hospital Clinic of Barcelona
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gemma Casals Hospital Clínic de Barcelona
PRS Account Hospital Clinic of Barcelona
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP