Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001268831
Ethics application status
Approved
Date submitted
25/09/2012
Date registered
4/12/2012
Date last updated
4/12/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Transferring embryos by two catheters compared to one catheter, in the same intracytoplasmic sperm injection (ICSI) cycle in infertile patients
Scientific title
Comparison of double embryo transfer by two catheters, with embryo transfer by single catheter on clinical pregnancy rate in infertility patients: a randomised controlled trial
Secondary ID [1] 281302 0
'Nil'
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
infertility 287509 0
Condition category
Condition code
Reproductive Health and Childbirth 287837 287837 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
during icsi cycle, after controlled ovarian stimulation oocytes will be picked up and icsi will be performed.Controlled ovarian stimulation will be performed as long analog protocol in which lucrin as gonadotrophin analog will be used In this protocol, participants will take lucrin daily 10 microgram subcutaneously, beginning from 21th day of menstrual cycle up to third day of their next menstruation.After than, lucrin (luprolide acetate)dosage will be decreased to 5 microgram and will continiously be applied up to day of human corionic gonadotrophin(hCG),(Pregnyl 10000Units) administration.On tirth day of menstruation fixed dosage of 225Units of gonadotrophin(Gonal F) will be applied and will continue up to the day of hCG administration, also.36 hours after hCG, oocytes will be picked up by aspiration in once session under vaginal ultrasonography.Oocytes will be put culture medium and intacytoplasmic sperm injection will be applied by embryologist. 3 to 5 days later,after blastocysts were obtained, two embryo will be transferred by one catheter in control group (as usual), two embryos will be transferred by two catheters in two times in study(intervention) group.Catheters will be used in both groups are all commercially available similar catheters.
Embryos will be transferred, when they reach 8 cell stage.Total number of embryos will be determined according to availibility of quality embryos (three or four embryos)
Intervention code [1] 285765 0
Treatment: Drugs
Comparator / control treatment
control group will be composed of women who get transfer two embryos in single catheter in one attempt.
Control group
Active

Outcomes
Primary outcome [1] 288053 0
clinical pregnancy rate after two different type of embryo transfers.
Clinical pregnancy will be positive if gestational sac would be seen by transvaginal ultrasonography.
Timepoint [1] 288053 0
21 days after transfer
Secondary outcome [1] 299342 0
implantation rates and biochemical pregnancy rates after transfer.Implantation rates and biochemical pregnancy rates will be determined by serum free hcg greater than 10IU/ml at 12 days after the transfer.
Timepoint [1] 299342 0
12 days after transfer

Eligibility
Key inclusion criteria
primary infertile women, age ranging 23years to 39years
Minimum age
23 Years
Maximum age
39 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
women with systemic diseases such as diabetus, hypertension, women having child before(secondary infertil) excluded

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/12/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment outside Australia
Country [1] 4570 0
Turkey
State/province [1] 4570 0

Funding & Sponsors
Funding source category [1] 286058 0
Self funded/Unfunded
Name [1] 286058 0
YAVUZ AYDIN
Country [1] 286058 0
Turkey
Primary sponsor type
Individual
Name
yavuz ayin
Address
atakent mah.soyakolimpiakent sit.d12 blok.halkali/istanbul
Post code:34303
Country
Turkey
Secondary sponsor category [1] 284871 0
None
Name [1] 284871 0
none
Address [1] 284871 0
none
Country [1] 284871 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
during icsi cycles for infertility traetment, transfer of two embryo will be achieved in one attempt with one catheter in control group , and will be achieved in two attempts with two catheters in study group.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34756 0
Address 34756 0
Country 34756 0
Phone 34756 0
Fax 34756 0
Email 34756 0
Contact person for public queries
Name 18003 0
yavuz aydin
Address 18003 0
atakent mah.soyakolimpiakent sit d 12 blok no 53 halkali/ istanbul post kode: 34303
Country 18003 0
Turkey
Phone 18003 0
+902124143000
Fax 18003 0
Email 18003 0
[email protected]
Contact person for scientific queries
Name 8931 0
yavuz aydin
Address 8931 0
atakent mah.soyakolimpiakent sit d 12 blok no 53 halkali/ istanbul post kode: 34303
Country 8931 0
Turkey
Phone 8931 0
+902124143000- 10342
Fax 8931 0
Email 8931 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.