Clinical trial NCT03395067: Multidisciplinary Treatment of Obesity Prior to in Vitro Fertilization: Impact on Global Reproductive Outcomes (PRO-FIV Study)
Official title: Multidisciplinary Treatment of Obesity Prior to In Vitro Fertilization: Impact on Global Reproductive Outcomes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Infertility
Keywords: Obesity
Infertility
In vitro fertilization
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2018-01-10
Enrollment: 104
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial including 2 arms: intervention group and control group.
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: live birth rate of a healthy baby in a non-complicated pregnancy
timeFrame: 10 months after starting the IVF treatment
Secondary outcomes:
measure: anthropometric parameters: weight (kilograms)
timeFrame: 4 months after starting the intervention
measure: anthropometric parameters: body mass index - BMI (kilograms/metro2)
timeFrame: 4 months after starting the intervention
measure: anthropometric parameters: abdominal circumference (centimeters)
timeFrame: 4 months after starting the intervention
measure: hormonal parameters: antimullerian hormone (AMH)
timeFrame: 2 years (simultaneous analysis of all the biological samples)
measure: hormonal parameters: insulin
timeFrame: 2 years (simultaneous analysis of all the biological samples)
measure: hormonal parameters: leptin
timeFrame: 2 years (simultaneous analysis of all the biological samples)
measure: hormonal parameters: adiponectin
timeFrame: 2 years (simultaneous analysis of all the biological samples)
measure: hormonal parameters: ghrelin
timeFrame: 2 years (simultaneous analysis of all the biological samples)
measure: IVF outcomes: cycle cancellation rate
timeFrame: 3 months after starting IVF cycle
measure: IVF outcomes: gonadotropin doses (UI)
timeFrame: 3 months after starting IVF cycle
measure: IVF outcomes: number of oocytes
timeFrame: 3 months after starting IVF cycle
measure: IVF outcomes: number of embryos
timeFrame: 3 months after starting IVF cycle
measure: IVF outcomes: number of good quality embryos
timeFrame: 3 months after starting IVF cycle
measure: IVF outcomes: clinical pregnancy rate
timeFrame: 3 months after starting IVF cycle
measure: IVF outcomes: miscarriage rate
timeFrame: 3 months after starting IVF cycle
measure: fetal ultrasound
timeFrame: 26-30 weeks after confirmation of pregnancy
measure: postpartum anthropometric outcomes: maternal abdominal circumference (centimeters)
timeFrame: 12 months after the delivery
measure: postpartum anthropometric outcomes: maternal weight (kilograms)
timeFrame: 12 months after the delivery
measure: postpartum anthropometric outcomes: neonatal weight (grams)
timeFrame: 12 months after the delivery
measure: postpartum anthropometric outcomes: neonatal height (centimeters)
timeFrame: 12 months after the delivery
measure: postpartum anthropometric outcomes: neonatal skin fold measurements (millimeters)
timeFrame: 12 months after the delivery
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Gemma Casals
role: PRINCIPAL_INVESTIGATOR
References: