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

Hospital Clinic of Barcelona

Status

Unknown

Conditions

Infertility

Obesity

Treatments

Behavioral: Intervention group

Study type

Interventional

Funder types

Other

Identifiers

NCT03395067

HCB/2017/0730

Details and patient eligibility

About

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.

Full description

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.

Enrollment

104 estimated patients

Sex

Female

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

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