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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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12614000188639
Enrollment
150
Registered
2014-02-21
Start date
2014-03-03
Completion date
2015-04-15
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study is going to evaluate the correlation of HPV-DNA existence in sperm samples and infertility.Also, relationship between HPV infection and sperm DNA damage will be examined. In the literature, limited number of studies evaluating HPV positivity and infertility relation reported higher number of HPV positive male cases in infertile population compared with not-infertile cohort. Additionally, abortion rates are more common and on-going pregnancy rates are lower in patients (both male and female) with HPV infection in the literature. In summary, HPV infection may impair fertility with several mechanisms and should have to be elucidated especially in infertile cohort. This study aims to evaluate the relation between HPV infection and fertility outcomes in IVF/ICSI cycles and also aims to evaluate the relation between HPV infection and sperm DNA damage in this study population. More prospective studies are needed to support routine use of HPV DNA examination in infertile population.

Interventions

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 diagno

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.

Sponsors

Gamze Sinem Caglar
Lead SponsorIndividual

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
No

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026