Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000323325
Ethics application status
Approved
Date submitted
27/02/2017
Date registered
1/03/2017
Date last updated
27/02/2019
Date data sharing statement initially provided
27/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Does weight loss associated with bariatric surgery improve sperm function?
Scientific title
Understanding the effects of weight loss/improvements in obesity related co-morbidities on sperm function.
Secondary ID [1] 291288 0
Nil Known
Universal Trial Number (UTN)
U1111-1193-5570
Trial acronym
Barifertility
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Obesity 302247 0
infertility 302248 0
metabolic syndrome 302249 0
Condition category
Condition code
Reproductive Health and Childbirth 301842 301842 0 0
Fertility including in vitro fertilisation
Metabolic and Endocrine 301843 301843 0 0
Other metabolic disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Male patients undergoing bariatric surgery (sleeve gastrectomy [SG], Roux-en-Y gastric bypass [RYGB]) will be recruited to be apart of the non-randomized parallel arm within-subject design study. Semen and blood samples will be collected at 4 collection times from each participant over the study procedure;
1) Baseline to establish initial assessment of sperm quality and reproductive characteristics in each participant.
2) Prior to surgery and after heavy caloric restriction.
3) Initial weight loss (6 months post-surgery).
4) Stabilisation of weight loss (12 months post-surgery).
Intervention code [1] 297310 0
Not applicable
Comparator / control treatment
A no intervention control will be used to determine subject variation over time which we will recruit from men who have had a consultation in the clinic however decide to not go ahead with the surgery.
Control group
Active

Outcomes
Primary outcome [1] 301262 0
Sperm ROS concentrations.
Sperm ROS concentrations are currently the only proven causative mediator in paternal programming. Current clinical measures of sperm count, motility and morphology have no relationship with determining pregnancy success or offspring health.
Timepoint [1] 301262 0
12 months post surgery
Stabilisation of weight loss
Primary outcome [2] 301263 0
Sperm ROS concentrations
Sperm ROS concentrations are currently the only proven causative mediator in paternal programming. Current clinical measures of sperm count, motility and morphology have no relationship with determining pregnancy success or offspring health.
Timepoint [2] 301263 0
6 months post surgery
Initial weight loss
Primary outcome [3] 301264 0
Sperm ROS concentrations.
Sperm ROS concentratios are currently the only proven causative mediator in paternal programming. Current clinical measures of sperm count, motility and morphology have no relationship with determining pregnancy success or offspring health.
Timepoint [3] 301264 0
After caloric restriction
Determine the effects of a very low caloric restriction (400-800 calories per day).
Secondary outcome [1] 332127 0
Sperm Count
Timepoint [1] 332127 0
After caloric restriction, 6 months and 12 months post surgery
Secondary outcome [2] 332130 0
Sperm binding and hyper activation (Composite)
These measures correlate to sperm maturity and are indirect markers of the ability of the sperm to bind to an egg.
Timepoint [2] 332130 0
After caloric restriction, 6 months and 12 months post surgery
Secondary outcome [3] 332215 0
Sperm Motility
Timepoint [3] 332215 0
After caloric restriction, 6 months and 12 months post surgery
Secondary outcome [4] 332216 0
Sperm Morphology
Timepoint [4] 332216 0
After caloric restriction, 6 months and 12 months post surgery

Eligibility
Key inclusion criteria
Inclusion Criteria
(1) BMI >30 kg/m2 and a waist circumferences of >102cm. These are the current standard criteria for categorising obesity. A number of studies assessing male obesity and fertility have used waist circumference in conjunction with BMI, as waist circumference in humans has been determined to be a better indicator for cardio metabolic disease risk.
(2) Males aged 18-40years. ROS the primary outcome is not altered in this age range. There are also little reported changes to other sperm parameters to be measured in this age range.
(3) At recruitment, patient is on a participating clinic’s waiting list to undergo a first-time SG, ABG or RYGB. To ensure participants in the study are not having a revision or conversion which may confound results.
Minimum age
18 Years
Maximum age
40 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria (known con-founders)
(1) Males who have had vasectomies or vasectomy reversals.
(2) Males with un-descendent testes, suspected pathologies related to fertility (i.e. varicoceles) or known genetic disorders that effect weight and fertility (i.e. Klinefelter's Syndrome, Prader-Willi or Larence-Moon-Bardet-Biedel).
(3) Males diagnosed with azoospermia at initial assessment. During the study period any results with implications for future or current fertility or for general wellbeing will be noted, and results will be sent to participant’s general practitioners, with the option for participants to be referred to fertility specialists.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Being a non-randomized study we expect differences in baseline characteristics across groups. Differences in age, physical activity, ethnicity, smoking status, history of disease, number of dependents, alcohol and drug intake, along with psychosocial status will be assessed using Mann-Whitney or Fisher exact tests as appropriate. The primary analysis is the association between weight loss and improvements in log transformed ROS. We expect that on average the RYBG will have the largest weight reduction, a moderate weight reduction in the SG group, and no weight loss the control group. As such the variation in weight change will be large, improving the power to detect an association with change in ROS as hypothesised. Applying Fisher’s correlation transformation with N=198 (66 in each group) then there is 80% power to detect a correlation of magnitude 0.2 (two-sided alpha=0.05), and 99% power to detect a correlation of magnitude 0.3. We expect an attrition rate of 15% based on previous studies this requires recruiting around 72 men in each arm for a total sample size N=216. The primary analysis will consist of mixed-effects regressions with log ROS change as the primary outcome and weight change the primary predictor of interest. Secondary analyses will explore the direct and moderating effects of patient level factors on ROS change, including nutrition levels (iron, B12, Folate, Zn, Mg, albumin, Vitamin D and Vitamin C) and cardio metabolic state (glucose, insulin, lipids, leptin, ghrelin, Hb, TFT, HbA1c creatinine, CRP, NT, proBNP, TNF-a and interleukins).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2019
Actual
Date of last participant enrolment
Anticipated
31/12/2019
Actual
Date of last data collection
Anticipated
31/12/2020
Actual
Sample size
Target
216
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 7567 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 7568 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [3] 7569 0
Flinders Private Hospital - Bedford Park
Recruitment hospital [4] 7570 0
Calvary Wakefield Hospital - Adelaide
Recruitment hospital [5] 7571 0
Calvary North Adelaide Hospital - North Adelaide
Recruitment hospital [6] 7572 0
Ashford Community Hospital - Ashford
Recruitment hospital [7] 7573 0
St John of God Hospital - Burwood
Recruitment postcode(s) [1] 15457 0
5000 - Adelaide
Recruitment postcode(s) [2] 15458 0
5011 - Woodville
Recruitment postcode(s) [3] 15459 0
5042 - Bedford Park
Recruitment postcode(s) [4] 15460 0
5000 - Adelaide
Recruitment postcode(s) [5] 15461 0
5006 - North Adelaide
Recruitment postcode(s) [6] 15462 0
5035 - Ashford
Recruitment postcode(s) [7] 15463 0
2134 - Burwood

Funding & Sponsors
Funding source category [1] 295754 0
University
Name [1] 295754 0
Robinson Research Institute, University of Adelaide
Country [1] 295754 0
Australia
Funding source category [2] 295755 0
University
Name [2] 295755 0
Freemasons Center for Mens Health, University of Adelaide
Country [2] 295755 0
Australia
Primary sponsor type
University
Name
Robinson Research Institute, University of Adelaide
Address
University of Adelaide
North Tec
Adelaide SA 5005
Country
Australia
Secondary sponsor category [1] 294598 0
University
Name [1] 294598 0
Freemasons Center for Mens Health, University of Adelaide
Address [1] 294598 0
University of Adelaide
North Tec
Adelaide SA 5005
Country [1] 294598 0
Australia
Other collaborator category [1] 279454 0
Commercial sector/Industry
Name [1] 279454 0
Monash IVF Group
Address [1] 279454 0
Pelaco Building 1
Level 1
21-31 Goodwood Street
Richmond VIC 3121 Australia
Country [1] 279454 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297054 0
Royal Adelaide Hospital Human Research Ethics Committee
Ethics committee address [1] 297054 0
Ethics committee country [1] 297054 0
Australia
Date submitted for ethics approval [1] 297054 0
06/02/2015
Approval date [1] 297054 0
19/02/2015
Ethics approval number [1] 297054 0
HREC/15/RAH/36

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

Contacts
Principal investigator
Name 72822 0
Dr Nicole McPherson
Address 72822 0
Level 3 Medical School South
Frome Rd
University of Adelaide, SA, 5005
Country 72822 0
Australia
Phone 72822 0
+61883138201
Fax 72822 0
Email 72822 0
[email protected]
Contact person for public queries
Name 72823 0
Nicole McPherson
Address 72823 0
Level 3 Medical School South
Frome Rd
University of Adelaide, SA, 5005
Country 72823 0
Australia
Phone 72823 0
+61883138201
Fax 72823 0
Email 72823 0
[email protected]
Contact person for scientific queries
Name 72824 0
Nicole McPherson
Address 72824 0
Level 3 Medical School South
Frome Rd
University of Adelaide, SA, 5005
Country 72824 0
Australia
Phone 72824 0
+61883138201
Fax 72824 0
Email 72824 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No approved for data sharing in current ethics


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.