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Trial registered on ANZCTR


Registration number
ACTRN12615000668505
Ethics application status
Approved
Date submitted
21/09/2014
Date registered
26/06/2015
Date last updated
26/06/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Will intracytoplasmic morphologically selected sperm injection replace intracytoplasmic sperm injection in cases of severe oligo-astheno-teratozoospermia ? A prospective study comparing pregnancy outcome
Scientific title
Is intracytoplasmic morphologically selected sperm injection (IMSI) more effective than intracytoplasmic sperm injection (ISCI) in cases of severe oligo-astheno-teratozoospermia? A prospective study regarding pregnancy outcome
Secondary ID [1] 285376 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
male factor infertility and IMSI 293107 0
Condition category
Condition code
Reproductive Health and Childbirth 293380 293380 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All the cases with severe oligoathenospermia (OAT) from 2012 to 2013 were counseled about the efficacy of the intracystoplasmic morphologicaly selected sperm injection (IMSI ) technique and its possible role for increasing the pregnancy rate, those accepted and consented on the new technique were enrolled in the study for IMSI group. For IMSI, spermatozoa were selected at 6600× magnification using an inverted microscope equipped with Nomarski (differential interference contrast) optics.
it may be administered on multiple occasions within a given time period.
IMSI is an advanced and sophisticated method of ICSI, where prior to sperm injection, the morphology of the sperm is evaluated under high magnification. In addition, the IMSI procedure involves a few minor modifications in sperm preparation which are not carried out during the conventional ICSI procedure, such as the use of MSOME criteria, the requirement for a glass-bottomed dish for selection, prolonged sperm manipulation following separation from the seminal fluid, and sperm storage prior to microinjection.

The maximal number of times that this procedure may be undertaken in each couple is 3 times, and the overall duration of the intervention period is once every 2 months.
Intervention code [1] 290289 0
Other interventions
Comparator / control treatment
For conventional intracytoplasmic sperm injection (ICSI) , spermatozoa were selected at 400 times magnification.
it may be administered on multiple occasions within a given time period.

The maximal number of times that this procedure may be undertaken in each couple is 3 times , and the overall duration of the intervention period is once every 2 months .
Control group
Active

Outcomes
Primary outcome [1] 293208 0
The primary outcome measure is the pregnancy rate which is diagnosed by positive serum beta-hCG assay (> 50 IU/L) 14 days after embryo transfer (ET) . Moreover, clinical pregnancy is confirmed by observing the number of the gestational sacs and fetal cardiac pulsations 2 weeks after positive beta -hCG test by trans-vaginal ultrasonography (TVS).
Timepoint [1] 293208 0
one year
Secondary outcome [1] 311082 0
embryo grade by microscopy
Timepoint [1] 311082 0
5days
Secondary outcome [2] 315280 0
Fertilization rate
Timepoint [2] 315280 0
One month

Eligibility
Key inclusion criteria
very poor semen quality characterized by severe oligo-astheno-teratozoospermia (sperm concentration less than 5 million per ml, less than 50% motile sperms according to WHO criteria and less than 14% morphologically normal spermatozoa according to the Strict Kruger Criteria), a normal karyotype in both partners
.
Minimum age
25 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Uterine defects, hydrosalpinx, endometriosis, polycystic ovaries, evidence of low ovarian response in previous treatment cycles (less than four oocytes retrieved), infections, endocrinal problems, coagulation defects or thrombophilia and autoimmune defects (including antiphospholipid antibodies) were all excluded.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Completed
Date of first participant enrolment
Anticipated
1/10/2012
Actual
1/10/2012
Date of last participant enrolment
Anticipated
Actual
30/06/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
1729
Accrual to date
Final
Recruitment outside Australia
Country [1] 6371 0
Egypt
State/province [1] 6371 0
alexandria

Funding & Sponsors
Funding source category [1] 289986 0
Self funded/Unfunded
Name [1] 289986 0
yasser orief
Country [1] 289986 0
Egypt
Primary sponsor type
University
Name
alexandria university, faculty of medicne
Address
Alexandria Faculty of Medicine, Champollion St.
Azarita PO box: 21131
Alexandria
Egypt
Country
Egypt
Secondary sponsor category [1] 288671 0
None
Name [1] 288671 0
none
Address [1] 288671 0
none
Country [1] 288671 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 51582 0
A/Prof yasser ibrahim orief
Address 51582 0
Alexandria university , Egypt
Elmoshier Ahmed Ismaiel Avenue, Panorama Alshark building, sidi Gaber Elshiekh, Alexandria, Egypt.
21615
Country 51582 0
Egypt
Phone 51582 0
+20 100 8233 121
Fax 51582 0
Email 51582 0
yaserorief@yahoo.com
Contact person for public queries
Name 51583 0
yasser orief
Address 51583 0
Alexandria university , Egypt
El Mosheer Ahmed Ismail St., Panorama El shark Building
Sidi gaber Elsheikh tram station above HSBC bank. PO box: 21615
Alexandria, Egypt
Country 51583 0
Egypt
Phone 51583 0
+20 100 8233 121
Fax 51583 0
Email 51583 0
yaserorief@yahoo.com
Contact person for scientific queries
Name 51584 0
yasser orief
Address 51584 0
Alexandria university, Alexandria
El Mosheer Ahmed Ismail St., Panorama El shark Building
Sidi gaber Elsheikh tram station above HSBC bank. PO box: 21615
Alexandria, Egypt
Country 51584 0
Egypt
Phone 51584 0
+20 100 8233 121
Fax 51584 0
Email 51584 0
yaserorief@yahoo.com

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.