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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Multidisciplinary Treatment of Obesity Prior to In Vitro Fertilization: Impact on Global Reproductive Outcomes

Conditions
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Obesity, Infertility

Intervention / Treatment
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* Behavioral: Intervention group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial including 2 arms: intervention group and control group.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lifestyle counseling<br> | Behavioral: Intervention group<br>* Lifestyle counseling coupled with psychotherapeutical intervention<br>|
| No Intervention: Control group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anthropometric parameters: weight (kilograms) | weight change during intervention, measured in kilograms | 4 months after starting the intervention | 
| anthropometric parameters: body mass index - BMI (kilograms/metro2) | BMI change during intervention, measured as kilograms/metro2 | 4 months after starting the intervention | 
| anthropometric parameters: abdominal circumference (centimeters) | abdominal circumference change during intervention measured in centimeters | 4 months after starting the intervention | 
| hormonal parameters: antimullerian hormone (AMH) | AMH serum levels before the intervention (intervention group) and before the IVF (2 arms) | 2 years (simultaneous analysis of all the biological samples) | 
| hormonal parameters: insulin | insulin serum levels before the intervention (intervention group) and before the IVF (2 arms) | 2 years (simultaneous analysis of all the biological samples) | 
| hormonal parameters: leptin | leptin serum levels before the intervention (intervention group) and before the IVF (2 arms) | 2 years (simultaneous analysis of all the biological samples) | 
| hormonal parameters: adiponectin | adiponectin serum levels before the intervention (intervention group) and before the IVF (2 arms) | 2 years (simultaneous analysis of all the biological samples) | 
| hormonal parameters: ghrelin | ghrelin serum levels before the intervention (intervention group) and before the IVF (2 arms) | 2 years (simultaneous analysis of all the biological samples) | 
| IVF outcomes: cycle cancellation rate | cycle cancellation rate: cancelled cycles/ initiated cycles | 3 months after starting IVF cycle | 
| IVF outcomes: gonadotropin doses (UI) | total gonadotropin doses used in the IVF stimulation protocol | 3 months after starting IVF cycle | 
| IVF outcomes: number of oocytes | number of oocytes retrieved | 3 months after starting IVF cycle | 
| IVF outcomes: number of embryos | total number of embryos obtained in 2 pronuclear stage | 3 months after starting IVF cycle | 
| IVF outcomes: number of good quality embryos | number of good quality embryos (type A and B) obtained in the cleavage stage | 3 months after starting IVF cycle | 
| IVF outcomes: clinical pregnancy rate | clinical pregnancy rate: clinical pregnancies/started cycles | 3 months after starting IVF cycle | 
| IVF outcomes: miscarriage rate | miscarriage rate: miscarriages/clinical pregnancies | 3 months after starting IVF cycle | 
| 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. | 26-30 weeks after confirmation of pregnancy | 
| postpartum anthropometric outcomes: maternal abdominal circumference (centimeters) | Maternal abdominal circumference in centimeters 1 month and 12 months after the delivery | 12 months after the delivery | 
| postpartum anthropometric outcomes: maternal weight (kilograms) | Maternal weight in kilograms 1 month and 12 months after the delivery | 12 months after the delivery | 
| postpartum anthropometric outcomes: neonatal weight (grams) | neonatal weight in grams 1 month and 12 months after the delivery | 12 months after the delivery | 
| postpartum anthropometric outcomes: neonatal height (centimeters) | neonatal height in centimeters 1 month and 12 months after the delivery | 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 | 12 months after the delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Infertility, In vitro fertilization