Multidisciplinary Treatment of Obesity Prior to in Vitro Fertilization: Impact on Global Reproductive Outcomes (PRO-FIV Study) (PRO-FIV)
Primary Purpose
Obesity, Infertility
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Intervention group
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring Obesity, Infertility, In vitro fertilization
Eligibility 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
Sites / Locations
- Hospital Clínic de BarcelonaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Lifestyle counseling
Control group
Arm Description
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
anthropometric parameters: weight (kilograms)
weight change during intervention, measured in kilograms
anthropometric parameters: body mass index - BMI (kilograms/metro2)
BMI change during intervention, measured as kilograms/metro2
anthropometric parameters: abdominal circumference (centimeters)
abdominal circumference change during intervention measured in centimeters
hormonal parameters: antimullerian hormone (AMH)
AMH serum levels before the intervention (intervention group) and before the IVF (2 arms)
hormonal parameters: insulin
insulin serum levels before the intervention (intervention group) and before the IVF (2 arms)
hormonal parameters: leptin
leptin serum levels before the intervention (intervention group) and before the IVF (2 arms)
hormonal parameters: adiponectin
adiponectin serum levels before the intervention (intervention group) and before the IVF (2 arms)
hormonal parameters: ghrelin
ghrelin serum levels before the intervention (intervention group) and before the IVF (2 arms)
IVF outcomes: cycle cancellation rate
cycle cancellation rate: cancelled cycles/ initiated cycles
IVF outcomes: gonadotropin doses (UI)
total gonadotropin doses used in the IVF stimulation protocol
IVF outcomes: number of oocytes
number of oocytes retrieved
IVF outcomes: number of embryos
total number of embryos obtained in 2 pronuclear stage
IVF outcomes: number of good quality embryos
number of good quality embryos (type A and B) obtained in the cleavage stage
IVF outcomes: clinical pregnancy rate
clinical pregnancy rate: clinical pregnancies/started cycles
IVF outcomes: miscarriage rate
miscarriage rate: miscarriages/clinical pregnancies
fetal ultrasound
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)
Maternal abdominal circumference in centimeters 1 month and 12 months after the delivery
postpartum anthropometric outcomes: maternal weight (kilograms)
Maternal weight in kilograms 1 month and 12 months after the delivery
postpartum anthropometric outcomes: neonatal weight (grams)
neonatal weight in grams 1 month and 12 months after the delivery
postpartum anthropometric outcomes: neonatal height (centimeters)
neonatal height in centimeters 1 month and 12 months after the delivery
postpartum anthropometric outcomes: neonatal skin fold measurements (millimeters)
neonatal skin fold measurements in millimeters 1 month and 12 months after the delivery
Full Information
NCT ID
NCT03395067
First Posted
December 17, 2017
Last Updated
January 28, 2018
Sponsor
Hospital Clinic of Barcelona
1. Study Identification
Unique Protocol Identification Number
NCT03395067
Brief Title
Multidisciplinary Treatment of Obesity Prior to in Vitro Fertilization: Impact on Global Reproductive Outcomes (PRO-FIV Study)
Acronym
PRO-FIV
Official Title
Multidisciplinary Treatment of Obesity Prior to In Vitro Fertilization: Impact on Global Reproductive Outcomes
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 28, 2018 (Anticipated)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Clinic of Barcelona
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Infertility
Keywords
Obesity, Infertility, In vitro fertilization
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial including 2 arms: intervention group and control group.
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
104 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lifestyle counseling
Arm Type
Active Comparator
Arm Title
Control group
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Intervention group
Intervention Description
Lifestyle counseling coupled with psychotherapeutical intervention
Primary Outcome Measure Information:
Title
live birth rate of a healthy baby in a non-complicated pregnancy
Description
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)
Time Frame
10 months after starting the IVF treatment
Secondary Outcome Measure Information:
Title
anthropometric parameters: weight (kilograms)
Description
weight change during intervention, measured in kilograms
Time Frame
4 months after starting the intervention
Title
anthropometric parameters: body mass index - BMI (kilograms/metro2)
Description
BMI change during intervention, measured as kilograms/metro2
Time Frame
4 months after starting the intervention
Title
anthropometric parameters: abdominal circumference (centimeters)
Description
abdominal circumference change during intervention measured in centimeters
Time Frame
4 months after starting the intervention
Title
hormonal parameters: antimullerian hormone (AMH)
Description
AMH serum levels before the intervention (intervention group) and before the IVF (2 arms)
Time Frame
2 years (simultaneous analysis of all the biological samples)
Title
hormonal parameters: insulin
Description
insulin serum levels before the intervention (intervention group) and before the IVF (2 arms)
Time Frame
2 years (simultaneous analysis of all the biological samples)
Title
hormonal parameters: leptin
Description
leptin serum levels before the intervention (intervention group) and before the IVF (2 arms)
Time Frame
2 years (simultaneous analysis of all the biological samples)
Title
hormonal parameters: adiponectin
Description
adiponectin serum levels before the intervention (intervention group) and before the IVF (2 arms)
Time Frame
2 years (simultaneous analysis of all the biological samples)
Title
hormonal parameters: ghrelin
Description
ghrelin serum levels before the intervention (intervention group) and before the IVF (2 arms)
Time Frame
2 years (simultaneous analysis of all the biological samples)
Title
IVF outcomes: cycle cancellation rate
Description
cycle cancellation rate: cancelled cycles/ initiated cycles
Time Frame
3 months after starting IVF cycle
Title
IVF outcomes: gonadotropin doses (UI)
Description
total gonadotropin doses used in the IVF stimulation protocol
Time Frame
3 months after starting IVF cycle
Title
IVF outcomes: number of oocytes
Description
number of oocytes retrieved
Time Frame
3 months after starting IVF cycle
Title
IVF outcomes: number of embryos
Description
total number of embryos obtained in 2 pronuclear stage
Time Frame
3 months after starting IVF cycle
Title
IVF outcomes: number of good quality embryos
Description
number of good quality embryos (type A and B) obtained in the cleavage stage
Time Frame
3 months after starting IVF cycle
Title
IVF outcomes: clinical pregnancy rate
Description
clinical pregnancy rate: clinical pregnancies/started cycles
Time Frame
3 months after starting IVF cycle
Title
IVF outcomes: miscarriage rate
Description
miscarriage rate: miscarriages/clinical pregnancies
Time Frame
3 months after starting IVF cycle
Title
fetal ultrasound
Description
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.
Time Frame
26-30 weeks after confirmation of pregnancy
Title
postpartum anthropometric outcomes: maternal abdominal circumference (centimeters)
Description
Maternal abdominal circumference in centimeters 1 month and 12 months after the delivery
Time Frame
12 months after the delivery
Title
postpartum anthropometric outcomes: maternal weight (kilograms)
Description
Maternal weight in kilograms 1 month and 12 months after the delivery
Time Frame
12 months after the delivery
Title
postpartum anthropometric outcomes: neonatal weight (grams)
Description
neonatal weight in grams 1 month and 12 months after the delivery
Time Frame
12 months after the delivery
Title
postpartum anthropometric outcomes: neonatal height (centimeters)
Description
neonatal height in centimeters 1 month and 12 months after the delivery
Time Frame
12 months after the delivery
Title
postpartum anthropometric outcomes: neonatal skin fold measurements (millimeters)
Description
neonatal skin fold measurements in millimeters 1 month and 12 months after the delivery
Time Frame
12 months after the delivery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gemma Casals
Phone
0034932275744
Email
gcasals@clinic.cat
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gemma Casals
Organizational Affiliation
Hospital Clinic of Barcelona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Clínic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gemma Casals
Phone
650533367
Email
gcasals@clinic.cat
12. IPD Sharing Statement
Learn more about this trial
Multidisciplinary Treatment of Obesity Prior to in Vitro Fertilization: Impact on Global Reproductive Outcomes (PRO-FIV Study)
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