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

Not Applicable

• Conditions: Obesity; Infertility
• Interventions: Behavioral: Intervention group

• Registration Number: NCT03395067
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2017-12-17
• Status Verified: 2018-01
• Study First Submitted QC: 2018-01-08
• Study First Posted: 2018-01-10
• Study Start: 2018-01-28
• Last Update Submitted: 2018-01-28
• Last Update Posted: 2018-01-30
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 104

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lifestyle counseling	Intervention group	-

Primary Outcome Measures

Name	Time	Method
live birth rate of a healthy baby in a non-complicated pregnancy	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

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

Trial Locations

Locations (1)

Hospital Clínic de Barcelona; 🇪🇸 Barcelona, Spain