Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000374561
Ethics application status
Approved
Date submitted
27/02/2015
Date registered
23/04/2015
Date last updated
23/04/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Seminal Plasma Galectin-3 levels in patients with male factor infertility undergoing assisted reproductive techniques (ART) and relation of Galectin-3 levels with sperm parameters and cycle outcomes
Scientific title
Seminal Plasma Galectin-3 levels in patients with male factor infertility undergoing assisted reproductive techniques (ART) and relation of Galectin-3 levels with sperm parameters and cycle outcomes
Secondary ID [1] 285545 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infertility 293362 0
Condition category
Condition code
Reproductive Health and Childbirth 293639 293639 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Seminal Plasma Galectin-3 levels in patients with male factor infertility undergoing assisted reproductive techniques (ART) and relation of Galectin-3 levels with sperm parameters and cycle outcomes. Sperm samples will be collected on a single occasion only at the time of assisted reproductive services.
Intervention code [1] 290491 0
Not applicable
Comparator / control treatment
There will be no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293455 0
Is to investigate the impact of seminal plasma Galectin-3 levels on sperm parameters in terms of total count per mL, motility and morphology in subjects undergoing assisted reproductive technology (ART). Association between Galectin levels and spermatogenesis will be determined.
Timepoint [1] 293455 0
Baseline Galectin-3 levels will be determined at the time of assisted reproductive services along with sperm evaluation of subjects.
Secondary outcome [1] 311079 0
To determine the association between seminal plasma Galectin-3 levels and cycle outcomes of patients undergoing assisted reproductive techniques (ART); briefly:
Subjects will be divided into groups according to their sperm counts/mL. Following appropriate distribution of all cases, study groups will be compared according to their baseline sperm parameters and IVF cycle outcomes in terms of embryological data, embryo grading, biochemical pregnancy, clinical-ongoing pregnancy and abortion rates. Assessment of outcomes will be considered following completion of all IVF/ICSI cycles till pregnancy test. Baseline Galectin-3 levels will be determined at the time of assisted reproductive services.
Timepoint [1] 311079 0
Assessment of outcomes will be considered following completion of all IVF/ICSI cycles till pregnancy test.

Eligibility
Key inclusion criteria
male factor infertility
without prior history of testicular surgery
age between 18-40
with partner age of 18-40
normal karyotype
Minimum age
18 Years
Maximum age
40 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
-Subjects with prior testicular surgery
-Subjects undergoing assisted reproductive techniques with genetic screening
-Subjects under age 18 or above 40
-Subjects under medication resulting with altered sperm production
-Subjects with severe metabolic disorder

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/12/2014
Actual
5/01/2015
Date of last participant enrolment
Anticipated
1/04/2015
Actual
6/04/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment outside Australia
Country [1] 6436 0
Turkey
State/province [1] 6436 0

Funding & Sponsors
Funding source category [1] 290150 0
University
Name [1] 290150 0
Ufuk University School of Medicine, Department of Obstetrics and Gynecology
Country [1] 290150 0
Turkey
Primary sponsor type
University
Name
Ufuk University School of Medicine
Address
Mevlana Boulevard No 86-88
Ankara, Turkey
06700
Country
Turkey
Secondary sponsor category [1] 288860 0
None
Name [1] 288860 0
Address [1] 288860 0
Country [1] 288860 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 52290 0
Dr Emre Goksan Pabuccu
Address 52290 0
Ufuk University School of Medicine, Department of Obstetrics and Gynecology
Mevlana Boulevard No 86-88
Ankara, Turkey
06700
Country 52290 0
Turkey
Phone 52290 0
+90 532 414 7844
Fax 52290 0
Email 52290 0
[email protected]
Contact person for public queries
Name 52291 0
Emre Goksan Pabuccu
Address 52291 0
Ufuk University School of Medicine, Department of Obstetrics and Gynecology
Mevlana Boulevard No 86-88
Ankara, Turkey
06700
Country 52291 0
Turkey
Phone 52291 0
+90 532 414 7844
Fax 52291 0
Email 52291 0
[email protected]
Contact person for scientific queries
Name 52292 0
Emre Goksan Pabuccu
Address 52292 0
Ufuk University School of Medicine, Department of Obstetrics and Gynecology
Mevlana Boulevard No 86-88
Ankara, Turkey
06700
Country 52292 0
Turkey
Phone 52292 0
+90 532 414 7844
Fax 52292 0
Email 52292 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.