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

Hospital Clinic of Barcelona104 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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)

Time frame: 10 months after starting the IVF treatment

Secondary Outcomes

anthropometric parameters: weight (kilograms)

weight change during intervention, measured in kilograms

Time frame: 4 months after starting the intervention

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

BMI change during intervention, measured as kilograms/metro2

Time frame: 4 months after starting the intervention

anthropometric parameters: abdominal circumference (centimeters)

abdominal circumference change during intervention measured in centimeters

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 2 years (simultaneous analysis of all the biological samples)

IVF outcomes: cycle cancellation rate

cycle cancellation rate: cancelled cycles/ initiated cycles