Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000114549
Ethics application status
Approved
Date submitted
29/03/2006
Date registered
30/03/2006
Date last updated
30/03/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Diet and physical exercise prior and during In Vitro Fertilization (IVF) in infertile overweight women.
Scientific title
The effects of moderate energy restriction combined with exercise on In Vitro Fertilization (IVF) outcomes in infertile overweight women.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infertile overweight women 1079 0
Condition category
Condition code
Reproductive Health and Childbirth 1159 1159 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Recruited women will be randomized in one of the two groups (Control group or Intervention group) and participate in the study from the day of booking on untill oocyte pick up procedure (6 - 8 weeks).


Intervention group will receive information on dietary and exercice regimes.

1.Dietary regime (5500Kj or 1300calories):
one meal replacement with very low calorie diet (VLCD) and two meals from CSIRO brochure per day.
2. Exercise programme is a home-based progressive physical conditionning (using ruber tubing for resistance) and walking programme.
Intervention code [1] 944 0
Lifestyle
Comparator / control treatment
Control group will receive standard information on factors influencing fertility and advice on a healthy lifestile by dietion at CSIRO.
Control group
Active

Outcomes
Primary outcome [1] 1560 0
1. Pregnancy Rate (%)
Timepoint [1] 1560 0
Assessed two times: 2 weeks after the embryo transfer (hCG) and at week 6 of gestation by ultrasound
Primary outcome [2] 1561 0
2. Livebirth rate (%)
Timepoint [2] 1561 0
Assessed on week 20 of gestation
Primary outcome [3] 1562 0
3. Weight (kg) and waist circumference (cm)
Timepoint [3] 1562 0
Measured on 4 occasions:
a) on day of consent (during the week prior booking on for In Vitro Fertilization cycle)
b) day(s) before commencement of Synarel injections
c) 14 days after the commencement of Synarel injections
d) on day of oocyte collection procedure.
Secondary outcome [1] 2812 0
1. Number and quality of oocytes.
Timepoint [1] 2812 0
Assessed after oocyte pick up procedure.
Secondary outcome [2] 2813 0
2. Number and quality of embryos.
Timepoint [2] 2813 0
Assessed after ocyte pick up procedure.
Secondary outcome [3] 2814 0
3. Hormone profile, glucose, insulin and lipids.
Timepoint [3] 2814 0
Assessed on 4 occasions:
a) on day of consent (during the week prior booking on for In Vitro Fertilization cycle)
b) day(s) before commencement of Synarel injections
c) 14 days after the commencement of Synarel injections
d) on day of oocyte collection procedure.
Secondary outcome [4] 2815 0
4. Economic analysis.
Timepoint [4] 2815 0
Assessed at the end of the study.
Secondary outcome [5] 2816 0
5. Quality of life.
Timepoint [5] 2816 0
Assessed at the begining and the end of the study.

Eligibility
Key inclusion criteria
1. Women, who at least undergone one IVF cycle. 2. BMI between 29 and 45 kg/m2.
Minimum age
18 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Women with severe deseases. 2. Women on weight loss programme.

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)
Permuted block computerised sequence randomization, stratified allocation by age.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
In this study, participants are unaware of the intervention assingment.
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1267 0
Charities/Societies/Foundations
Name [1] 1267 0
Brailsford - Robertson grant
Country [1] 1267 0
Primary sponsor type
Government body
Name
CSIRO
Address
Country
Australia
Secondary sponsor category [1] 1122 0
University
Name [1] 1122 0
The University of Adelaide
Address [1] 1122 0
Country [1] 1122 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2597 0
Women's and Children's Hospital Human Research Ethics Committee
Ethics committee address [1] 2597 0
Ethics committee country [1] 2597 0
Australia
Date submitted for ethics approval [1] 2597 0
Approval date [1] 2597 0
04/08/2004
Ethics approval number [1] 2597 0
1601 / 06 /2007
Ethics committee name [2] 2598 0
Repromed
Ethics committee address [2] 2598 0
Ethics committee country [2] 2598 0
Australia
Date submitted for ethics approval [2] 2598 0
Approval date [2] 2598 0
21/07/2005
Ethics approval number [2] 2598 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35317 0
Address 35317 0
Country 35317 0
Phone 35317 0
Fax 35317 0
Email 35317 0
Contact person for public queries
Name 10133 0
Manny Noakes
Address 10133 0
Commonwealth Scientific and Industrial Research Organisation (CSIRO) Health Sciences and Nutrition
Gate 13
Kintore Avenue
Adelaide SA 5000
Country 10133 0
Australia
Phone 10133 0
+61 8 83038827
Fax 10133 0
+61 8 83038899
Email 10133 0
manny.noakes@csiro.au
Contact person for scientific queries
Name 1061 0
Helen Alvino
Address 1061 0
Repromed
180 Fullarton Road
Dulwich SA 5065
Country 1061 0
Australia
Phone 1061 0
+61 8 83338151
Fax 1061 0
+61 8 83338175
Email 1061 0
helen.alvino@adelaide.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.