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Trial registered on ANZCTR


Registration number
ACTRN12617000916347p
Ethics application status
Not yet submitted
Date submitted
13/06/2017
Date registered
22/06/2017
Date last updated
22/06/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of dynamic development between embryos originating from oocytes collected using single lumen and double lumen needle: a randomised sibling oocyte study
Scientific title
Morphokinetics of embryos originating from oocytes collected with the use of a single vs double lumen needle: a randomised sibling oocyte study
Secondary ID [1] 291309 0
None
Universal Trial Number (UTN)
U1111-1193-6144
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Embryo development 302282 0
Condition category
Condition code
Reproductive Health and Childbirth 301871 301871 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This trial will be comparing the effectiveness of single lumen needle (study group) against double lumen needle (control group) for the use of oocyte collection procedure. The single lumen needle is manufactured by the same supplier as the double lumen which are being used routinely at Fertility North, and both are for single use only. All oocyte collection procedures will be performed by one of the Fertility North specialists at the theatre of Joondalup Health Campus, with one ovary being aspirated using a single lumen and the other using a double lumen needle for each patient. Usually the egg collection procedure takes 10-40 mins. A one-off randomisation in terms of needle type and ovary order is to be performed before oocyte collection, with all other procedures carried out according to standard protocol at the clinic.
Intervention code [1] 297338 0
Treatment: Devices
Comparator / control treatment
Two ovaries of the same patient will be randomised for the order of collection and for either single lumen needle (study group) or double lumen needle (control) treatment. Fertilisation outcomes of sibling oocytes collected via both types of needle and developmental potential of subsequent embryos will be compared.
Control group
Active

Outcomes
Primary outcome [1] 301311 0
Time lapse score (A,B,C,D,E,F) of resulting embryos based on time-lapse photography captured by the Embryoscope.
Timepoint [1] 301311 0
64 hours post insemination
Secondary outcome [1] 332276 0
Oocyte recovery rate (number oocyte recovered/number of follicle)
Timepoint [1] 332276 0
At completion of oocyte collection
Secondary outcome [2] 332277 0
Fertilisation rate (Number of oocyte fertilised/number of oocyte inseminated)
Timepoint [2] 332277 0
20 hours post insemination
Secondary outcome [3] 336163 0
% of resulting embryos displaying direct cleavage as determined by annotation using the EmbryoViewer software.
Timepoint [3] 336163 0
64 hours post insemination
Secondary outcome [4] 336164 0
% of resulting embryos displaying revere cleavage as determined by annotation using the EmbryoViewer software.
Timepoint [4] 336164 0
64 hours post inseminatoin
Secondary outcome [5] 336165 0
% of resulting embryos displaying less than 6 contact points at the end of the 4-cell stage as determined by annotation using the EmbryoViewer software.
Timepoint [5] 336165 0
64 hours post insemination
Secondary outcome [6] 336166 0
time from pronuclear fading to the 5-cell stage as determined by annotation using the EmbryoViewer software.
Timepoint [6] 336166 0
64 hours post insemination

Eligibility
Key inclusion criteria
Patients attending Fertility North for IVF/ICSI treatment with more than 5 large follicles (>=13 mm) on both ovaries at trigger for oocyte collection, or equivalent size of follicles as per adjustment protocol at the clinic if the last ultrasound scan is not on the trigger day.
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with 5 or less large follicles in total will be excluded.
Patients with only one ovary will be excluded.
Patients with oocytes collected from only one ovary will be excluded from fertilisation and embryology comparisons..
Patients with fertilisation failure in oocytes or no mature eggs collected from single or both ovaries.will be excluded from embryology comparisons..

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Each participant receives both control treatment and intervention, with oocytes collected from either ovary forming two arms of this study. Therefore, participants act as their own control.
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
7/08/2017
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 295778 0
Commercial sector/Industry
Name [1] 295778 0
Fertility North
Country [1] 295778 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Fertility North
Address
Suite 30, Level 2, Joondalup Private Hospital,
60 Shenton Ave, Joondalup
Country
Australia
Secondary sponsor category [1] 294627 0
None
Name [1] 294627 0
Address [1] 294627 0
Country [1] 294627 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 297076 0
Joondalup Health Campus Human Research Ethics Committee
Ethics committee address [1] 297076 0
Shenton Ave, Joondalup WA 6027
Ethics committee country [1] 297076 0
Date submitted for ethics approval [1] 297076 0
20/07/2017
Approval date [1] 297076 0
Ethics approval number [1] 297076 0

Summary
Brief summary
This study aims to assess the efficacy of single lumen needle compared to the double lumen needle which has been routinely used at Fertility North. Each ovary of patients undertaking oocyte collection as part of their IVF/ICSI treatment is aspirated by either a single lumen or double lumen needle after randomisation in randomised order. Subsequent oocytes and resulting embryos are tracked according to their origin, and fertilisation and time-lapse embryology parameters are compared between 2 groups..
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 72890 0
Dr Vincent Chapple
Address 72890 0
Fertility North
Suite 30, Level 2, Joondalup Private Hospital,
60 Shenton Ave, Joondalup WA 6027
Country 72890 0
Australia
Phone 72890 0
+61 8 9301 1075
Fax 72890 0
Email 72890 0
[email protected]
Contact person for public queries
Name 72891 0
Katie Feenan
Address 72891 0
Fertility North
Suite 30, Level 2, Joondalup Private Hospital,
60 Shenton Ave, Joondalup WA 6027
Country 72891 0
Australia
Phone 72891 0
+61 8 9301 1075
Fax 72891 0
Email 72891 0
[email protected]
Contact person for scientific queries
Name 72892 0
Katie Feenan
Address 72892 0
Fertility North
Suite 30, Level 2, Joondalup Private Hospital,
60 Shenton Ave, Joondalup WA 6027
Country 72892 0
Australia
Phone 72892 0
+61 8 9301 1075
Fax 72892 0
Email 72892 0
[email protected]

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.