Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000188639
Ethics application status
Approved
Date submitted
3/02/2014
Date registered
21/02/2014
Date last updated
28/05/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Deoxyribonucleic acid (DNA) and Sperm DNA Fragmentation Investigation in Patients Undergoing In vitro fertilisation (IVF)/Intracytoplasmic sperm injection (ICSI) with History of Recurrent Implantation Failure and/or Recurrent Pregnancy Loss
Scientific title
Deoxyribonucleic acid (DNA) and Sperm DNA Fragmentation Investigation in Patients Undergoing In vitro fertilisation (IVF)/Intracytoplasmic sperm injection (ICSI) with History of Recurrent Implantation Failure and/or Recurrent Pregnancy Loss
Secondary ID [1] 284016 0
none
Universal Trial Number (UTN)
U1111-1152-7949
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
patients with recurrent IVF failure and/or implantation failure 291054 0
Condition category
Condition code
Reproductive Health and Childbirth 291397 291397 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
Human Papilloma Virus DNA Assessment and Sperm DNA Fragmentation Investigation will be performed on sperm samples of patients with history of recurrent pregnancy loss and/or recurrent implantation failure. After having informed consent, 250 microL of sperm sample will be reserved from each participant on the day of oocyte retrieval for HPV DNA and DNA fragmentation assessment. HPV DNA will be determined with polymerase chain reaction (PCR) technique using commercial kit. If the sample get diagnosed as positive for HPV, genotyping will be performed. Sperm DNA fragmentation (damage) will be analyzed using Terminal deoxynucleotidyl transferase dUTP nick end labeling (TUNEL) assay with commercial kit. Correlation between HPV status and DNA fragmentation of the sperm sample will be determined and further correlation analysis regarding IVF/ICSI cycle outcomes and sperm assessments will be discussed. Total duration of the study will be approximately 6 months.
Intervention code [1] 288702 0
Not applicable
Comparator / control treatment
In the current study, standard controlled ovarian hyper stimulation procedure will be applied to infertile patient population, thus there will be no control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291390 0
HPV DNA will be investigated in seminal plasma of sperm samples using polymerase chain reaction technique and DNA fragmentation
will be investigated in sperm samples using Terminal deoxynucleotidyl transferase dUTP nick end labeling (TUNEL) assay.
Timepoint [1] 291390 0
Immediately after sperm samples for HPV DNA and DNA fragmentation investigations have been collected and completed
Secondary outcome [1] 306929 0
Correlation between sperm DNA existence (DNA positive or negative per sample) and sperm DNA fragmentation (percent % index per patient) using statistical model
Timepoint [1] 306929 0
Immediately after sperm samples for HPV DNA and DNA fragmentation investigations have been collected and completed

Eligibility
Key inclusion criteria
*18-45 years old
*IVF/ICSI indication due to primary or secondary infertility
*History of failure to achieve a clinical pregnancy after transfer of at least four good-quality embryos in a minimum of three fresh or frozen cycles in a woman under the age of 40years
*History of 2 or more pregnancy losses before 20th week of gestation
*non smokers
*subjects with female partner of less than 35 years old
*not having documented sexually transmitted disease
*not having a history of genital tract operation
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
*smokers
*documented azoospermia
*female partner older than age 35
*documented poor ovarian reserve or high ovarian response in females
*documented sexually transmitted disease for both participants
*history of genital tract surgery in male participant

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis
To predict 5% more sperm DNA fragmentation cases in one of the HPV DNA positive cases, total of 117 patients should be allocated within 0,05 type 1 error and 0,80 power. Power calculations was performed using NCSS PASS 2007.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
25/02/2014
Actual
3/03/2014
Date of last participant enrolment
Anticipated
16/03/2015
Actual
15/04/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment outside Australia
Country [1] 5800 0
Turkey
State/province [1] 5800 0

Funding & Sponsors
Funding source category [1] 288652 0
Self funded/Unfunded
Name [1] 288652 0
Gamze Sinem Caglar Assoc.Prof. MD
Ufuk University Faculty of Medicine, Department of Obstetrics and Gynecology
Country [1] 288652 0
Turkey
Primary sponsor type
Individual
Name
Gamze Sinem Caglar
Address
Ufuk University Faculty of Medicine, Department of Obstetrics and Gynecology
Mevlana Bulvari No 86-88
Ankara, Turkey
06520
Country
Turkey
Secondary sponsor category [1] 287363 0
None
Name [1] 287363 0
Address [1] 287363 0
Country [1] 287363 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 45946 0
A/Prof Yasemin Tasci
Address 45946 0
Zekai Tahir Burak Women Research and Education Hospital
Talatpasa Bulvari Samanpazari / ANKARA
06340
Turkey
Country 45946 0
Turkey
Phone 45946 0
+90 532 441 8501
Fax 45946 0
Email 45946 0
[email protected]
Contact person for public queries
Name 45947 0
Gamze Sinem Caglar
Address 45947 0
Ufuk University Faculty of Medicine ,Department of Obstetrics and Gynecology
Mevlana Bulvari No 86-88
Ankara, Turkey
06520
Country 45947 0
Turkey
Phone 45947 0
+90532 414 7844
Fax 45947 0
Email 45947 0
[email protected]
Contact person for scientific queries
Name 45948 0
Gamze Sinem Caglar
Address 45948 0
Ufuk University Faculty of Medicine ,Department of Obstetrics and Gynecology
Mevlana Bulvari No 86-88
Ankara, Turkey
06520
Country 45948 0
Turkey
Phone 45948 0
+90312 204 4000
Fax 45948 0
Email 45948 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.