Multidisciplinary Treatment of Obesity Prior to in Vitro Fertilization: Impact on Global Reproductive Outcomes (PRO-FIV Study)
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Lifestyle counseling
|
Behavioral: Intervention group
Lifestyle counseling coupled with psychotherapeutical intervention
|
| No Intervention: Control group
|
Outcome Measures
Primary Outcome Measures
- 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
- anthropometric parameters: weight (kilograms) [4 months after starting the intervention]
weight change during intervention, measured in kilograms
- anthropometric parameters: body mass index - BMI (kilograms/metro2) [4 months after starting the intervention]
BMI change during intervention, measured as kilograms/metro2
- anthropometric parameters: abdominal circumference (centimeters) [4 months after starting the intervention]
abdominal circumference change during intervention measured in centimeters
- 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: 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: 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: adiponectin [2 years (simultaneous analysis of all the biological samples)]
adiponectin 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: cycle cancellation rate [3 months after starting IVF cycle]
cycle cancellation rate: cancelled cycles/ initiated cycles
- IVF outcomes: gonadotropin doses (UI) [3 months after starting IVF cycle]
total gonadotropin doses used in the IVF stimulation protocol
- 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
- 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
- IVF outcomes: miscarriage rate [3 months after starting IVF cycle]
miscarriage rate: miscarriages/clinical pregnancies
- 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 abdominal circumference (centimeters) [12 months after the delivery]
Maternal abdominal circumference in centimeters 1 month and 12 months after the delivery
- postpartum anthropometric outcomes: maternal weight (kilograms) [12 months after the delivery]
Maternal weight in kilograms 1 month and 12 months after the delivery
- 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 height (centimeters) [12 months after the delivery]
neonatal height in centimeters 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
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital Clínic de Barcelona | Barcelona | Spain | 08036 |
Sponsors and Collaborators
- Hospital Clinic of Barcelona
Investigators
- Principal Investigator: Gemma Casals, Hospital Clinic of Barcelona
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HCB/2017/0730