None listed
Conditions
Brief summary
The study is being undertaken because compared with normal weight women, obese women have lower fertility both in natural and ART cycles. Obesity is a risk factor for many maternal and fetal morbidities. Maternally these include an increased miscarriage rate, increased rates of pregnancy complications (gestational diabetes, hypertension), increased operative delivery rates and increased thrombotic events. Fetal risks include increased congenital anomalies and birth injuries.
Interventions
The study group patients will be provided with a Very Low Energy Diet (VLED) for 6 weeks (providing 1890-3192 kJ per day). Instructions and support will be given to each patient by a dietitian. Thereafter a hypocaloric diet will be introduced. According to VLED protocol, a physician will monitor patient’s electrolytes, liver function and pregnancy status. If a patient becomes pregnant they will switched immediately to a diet suitable for pregnancy. Patients will be given a pedometer and encourag
The study group patients will be provided with a Very Low Energy Diet (VLED) for 6 weeks (providing 1890-3192 kJ per day). Instructions and support will be given to each patient by a dietitian. Thereafter a hypocaloric diet will be introduced. According to VLED protocol, a physician will monitor patient’s electrolytes, liver function and pregnancy status. If a patient becomes pregnant they will switched immediately to a diet suitable for pregnancy. Patients will be given a pedometer and encouraged to increase their current activity level with the goal of reaching 10,000 steps 5 to 6 days a week. Patients will also be offered weekly group sessions for 12 weeks. These sessions will cover a wide range of weight and reproduction related topics, including diet and nutrition, the role of physical activity, psychological factors, and education regarding the reproductive consequences of obesity
Sponsors
Royal Prince Alfred Hospital - Fertility Unit
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 37 Years
Healthy volunteers
No
Inclusion criteria
A patient enrolled to undergo IVF at the Royal Prince Alfred Hospital Fertility Unit, and be clinically obese, defined as a BMI greater or equal to 30.0 kg/m2
Exclusion criteria
(1) individuals with current psychiatric conditions (i.e. psychosis, severe depression, and drug or alcohol abuse); (2) significant physical conditions (i.e. malignancy, significant hepatic or renal dysfunction or musculoskeletal disease that would preclude full participation in the study); (3) presence of an endocrine condition (other than polycystic ovarian syndrome), such as hyperprolactinaemia (> 450 IU/L), untreated thyroid disease and Cushing’s syndrome; (4) current or recent treatment (within 3 months) known to affect diet or body weight; and/or (5) patients unwilling to suspend IVF treatment for up to 3 months
Outcome results
None listed