Obesity Clinical Trial
— PRO-FIVOfficial title:
Multidisciplinary Treatment of Obesity Prior to In Vitro Fertilization: Impact on Global Reproductive Outcomes
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.
Status | Recruiting |
Enrollment | 104 |
Est. completion date | December 2020 |
Est. primary completion date | December 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Clínic de Barcelona | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Hospital Clinic of Barcelona |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | anthropometric parameters: weight (kilograms) | weight change during intervention, measured in kilograms | 4 months after starting the intervention | |
Secondary | anthropometric parameters: body mass index - BMI (kilograms/metro2) | BMI change during intervention, measured as kilograms/metro2 | 4 months after starting the intervention | |
Secondary | anthropometric parameters: abdominal circumference (centimeters) | abdominal circumference change during intervention measured in centimeters | 4 months after starting the intervention | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | IVF outcomes: cycle cancellation rate | cycle cancellation rate: cancelled cycles/ initiated cycles | 3 months after starting IVF cycle | |
Secondary | IVF outcomes: gonadotropin doses (UI) | total gonadotropin doses used in the IVF stimulation protocol | 3 months after starting IVF cycle | |
Secondary | IVF outcomes: number of oocytes | number of oocytes retrieved | 3 months after starting IVF cycle | |
Secondary | IVF outcomes: number of embryos | total number of embryos obtained in 2 pronuclear stage | 3 months after starting IVF cycle | |
Secondary | 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 | |
Secondary | IVF outcomes: clinical pregnancy rate | clinical pregnancy rate: clinical pregnancies/started cycles | 3 months after starting IVF cycle | |
Secondary | IVF outcomes: miscarriage rate | miscarriage rate: miscarriages/clinical pregnancies | 3 months after starting IVF cycle | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | postpartum anthropometric outcomes: maternal weight (kilograms) | Maternal weight in kilograms 1 month and 12 months after the delivery | 12 months after the delivery | |
Secondary | postpartum anthropometric outcomes: neonatal weight (grams) | neonatal weight in grams 1 month and 12 months after the delivery | 12 months after the delivery | |
Secondary | postpartum anthropometric outcomes: neonatal height (centimeters) | neonatal height in centimeters 1 month and 12 months after the delivery | 12 months after the delivery | |
Secondary | 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 |
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