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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

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.


Condition or disease Intervention/treatment
Obesity Infertility Behavioral: Intervention group

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 104 participants
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
Official Title: Multidisciplinary Treatment of Obesity Prior to In Vitro Fertilization: Impact on Global Reproductive Outcomes
Anticipated Study Start Date : January 28, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Lifestyle counseling Behavioral: Intervention group
Lifestyle counseling coupled with psychotherapeutical intervention
No Intervention: Control group



Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. anthropometric parameters: weight (kilograms) [ Time Frame: 4 months after starting the intervention ]
    weight change during intervention, measured in kilograms

  2. anthropometric parameters: body mass index - BMI (kilograms/metro2) [ Time Frame: 4 months after starting the intervention ]
    BMI change during intervention, measured as kilograms/metro2

  3. anthropometric parameters: abdominal circumference (centimeters) [ Time Frame: 4 months after starting the intervention ]
    abdominal circumference change during intervention measured in centimeters

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. IVF outcomes: cycle cancellation rate [ Time Frame: 3 months after starting IVF cycle ]
    cycle cancellation rate: cancelled cycles/ initiated cycles

  10. IVF outcomes: gonadotropin doses (UI) [ Time Frame: 3 months after starting IVF cycle ]
    total gonadotropin doses used in the IVF stimulation protocol

  11. IVF outcomes: number of oocytes [ Time Frame: 3 months after starting IVF cycle ]
    number of oocytes retrieved

  12. IVF outcomes: number of embryos [ Time Frame: 3 months after starting IVF cycle ]
    total number of embryos obtained in 2 pronuclear stage

  13. 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

  14. IVF outcomes: clinical pregnancy rate [ Time Frame: 3 months after starting IVF cycle ]
    clinical pregnancy rate: clinical pregnancies/started cycles

  15. IVF outcomes: miscarriage rate [ Time Frame: 3 months after starting IVF cycle ]
    miscarriage rate: miscarriages/clinical pregnancies

  16. 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.

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03395067


Contacts
Contact: Gemma Casals 0034932275744 gcasals@clinic.cat

Locations
Spain
Hospital Clínic de Barcelona Recruiting
Barcelona, Spain, 08036
Contact: Gemma Casals    650533367    gcasals@clinic.cat   
Sponsors and Collaborators
Hospital Clinic of Barcelona
Investigators
Principal Investigator: Gemma Casals Hospital Clínic de Barcelona

Responsible Party: Gemma Casals i Soler, Principal Investigator, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT03395067     History of Changes
Other Study ID Numbers: HCB/2017/0730
First Posted: January 10, 2018    Key Record Dates
Last Update Posted: January 30, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Gemma Casals i Soler, Hospital Clinic of Barcelona:
Obesity
Infertility
In vitro fertilization

Additional relevant MeSH terms:
Obesity
Infertility
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Genital Diseases, Male
Genital Diseases, Female