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Trial registered on ANZCTR


Registration number
ACTRN12606000448549
Ethics application status
Approved
Date submitted
10/10/2006
Date registered
18/10/2006
Date last updated
8/12/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
A weight-loss programme and subsequent fertility rates in an assisted reproductive technology programme
Scientific title
Does a weight-loss programme improve pregnancy rates in assisted reproductive technology?
Secondary ID [1] 253402 0
Nil
Universal Trial Number (UTN)
Trial acronym
WLART
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 1421 0
Condition category
Condition code
Diet and Nutrition 1517 1517 0 0
Obesity
Reproductive Health and Childbirth 1518 1518 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 1397 0
Lifestyle
Comparator / control treatment
The control group will receive the standard nutrition counselling provided by the Fertility Unit physicians and nurses. Subject will be encouraged to seek additional weight loss advice from their General Practitioner or if their BMI is = 35 kg/m2 from the Metabolism and Obesity Services at Royal Prince Alfred Hospital
Control group
Active

Outcomes
Primary outcome [1] 2095 0
Pregnancy rate (diagnosed as fetal heartbeat at 7 weeks gestation) per woman
Timepoint [1] 2095 0
At 12 months after the cessation of the 12 week program
Secondary outcome [1] 3614 0
ART measures (the mean number of cycles taken to achieve pregnancy, the mean number of oocytes fertilised and embryos cryostored per cycle)
Timepoint [1] 3614 0
Measured at 12 months after the cessation of the 12 week programme
Secondary outcome [2] 3615 0
? Antepartum, intrapartum and postpartum outcomes (including pregnancy outcome, miscarriage rate, antepartum outcomes, description of the onset of labour, the method of birth, postpartum outcomes, neonatal variables, the mean gestational age, the mean birth weight and the mean length of hospital stay)
Timepoint [2] 3615 0
Measured at 12 months after the cessation of the 12 week programme
Secondary outcome [3] 3616 0
Improvement in cardiovascular risk factors (BP measurements and HR)
Timepoint [3] 3616 0
Measured at the end of the 12 week intervention
Secondary outcome [4] 3617 0
Improvement in glucose utilisation (serum glucose and HbA1c)
Timepoint [4] 3617 0
Measured at the end of the 12 week intervention
Secondary outcome [5] 3618 0
Metabolic, endocrine and ovulational parameter changes (including insulin, TC, HDL-C, LDL-C, TG, leptin, adiponectin, ghrelin, LH, FSH, prolactin, SHBG, testosterone, DHEAS, oestradiol, progesterone, FAI and 17-OHP
Timepoint [5] 3618 0
Measured at the end of the 12 week intervention
Secondary outcome [6] 3619 0
Psychological parameters (IWQOL-Lite)
Timepoint [6] 3619 0
Measured at the end of the 12 week intervention
Secondary outcome [7] 3621 0
Compliance to the programme and subject feedback
Timepoint [7] 3621 0
Measured at the end of the 12 week intervention

Eligibility
Key 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
Minimum age
18 Years
Maximum age
37 Years
Gender
Females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random allocation using computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The ART physicians will be blinded
Phase
Phase 3
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1652 0
Hospital
Name [1] 1652 0
Royal Prince Alfred Hospital
Address [1] 1652 0
Missenden Road
Camperdown
NSW 2050
Country [1] 1652 0
Australia
Funding source category [2] 1653 0
University
Name [2] 1653 0
Institute of Obesity, Nutrition & Exercise
Address [2] 1653 0
K25 - Medical Foundation Building
The University of Sydney
NSW 2006
Country [2] 1653 0
Australia
Primary sponsor type
Hospital
Name
Royal Prince Alfred Hospital - Fertility Unit
Address
Missenden Road
Camperdown
NSW 2050
Country
Australia
Secondary sponsor category [1] 1461 0
University
Name [1] 1461 0
Institute of Obesity, Nutrition & Exercise
Address [1] 1461 0
K25 - Medical Foundation Building
The University of Sydney
NSW 2006
Country [1] 1461 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3101 0
Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 3101 0
Royal Prince Alfred Hospital, Camperdown, New South Wales
Ethics committee country [1] 3101 0
Australia
Date submitted for ethics approval [1] 3101 0
Approval date [1] 3101 0
21/08/2006
Ethics approval number [1] 3101 0
X06-0149

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27624 0
Address 27624 0
Country 27624 0
Phone 27624 0
Fax 27624 0
Email 27624 0
Contact person for public queries
Name 10586 0
Ian Caterson and Kyra Sim
Address 10586 0
The Boden Institute of Obesity, Nutrition, Exercise & Eating Disorders
Medical Foundation Building, K25
The University of Sydney NSW 2006
Country 10586 0
Australia
Phone 10586 0
+61 2 9036 3105
Fax 10586 0
+61 2 9036 3176
Email 10586 0
I.Caterson@mmb.usyd.edu.au, kyrasim@hotmail.com
Contact person for scientific queries
Name 1514 0
Kyra Sim
Address 1514 0
The Boden Institute of Obesity, Nutrition, Exercise & Eating Disorders
Medical Foundation Building, K25
The University of Sydney NSW 2006
Country 1514 0
Australia
Phone 1514 0
+61 2 9036 3110
Fax 1514 0
+61 2 9036 3176
Email 1514 0
kyrasim@hotmail.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary