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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03395067
Other study ID # HCB/2017/0730
Secondary ID
Status Recruiting
Phase N/A
First received December 17, 2017
Last updated January 28, 2018
Start date January 28, 2018
Est. completion date December 2020

Study information

Verified date January 2018
Source Hospital Clinic of Barcelona
Contact Gemma Casals
Phone 0034932275744
Email gcasals@clinic.cat
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Intervention group
Lifestyle counseling coupled with psychotherapeutical intervention

Locations

Country Name City State
Spain Hospital Clínic de Barcelona Barcelona

Sponsors (1)

Lead Sponsor Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

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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