Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06161727 |
| Other study ID # |
SpermHPV |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2023 |
| Est. completion date |
March 28, 2024 |
Study information
| Verified date |
April 2024 |
| Source |
Vastra Gotaland Region |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
This observational study aims to investigate the presence of HPV DNA in semen samples from
men undergoing in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI)
treatment. It focuses on understanding the impact of HPV on male fertility and embryo
development following IVF/ICSI. The primary goal is to determine the prevalence of
HPV-positive (HPV+) semen samples among men seeking infertility treatment with IVF/ICSI.
Additionally, the study aims to compare semen characteristics between HPV-positive and
HPV-negative (HPV-) samples and assess the embryological outcomes after IVF/ICSI in these two
groups.
Participants in this study will include men receiving IVF/ICSI treatment and providing fresh
ejaculated sperm at Sahlgrenska University Hospital in Gothenburg, Sweden, over one year.
Those undergoing treatments with surgically extracted sperm, sperm freezing for fertility
preservation, or planning treatments involving preimplantation genetic testing or egg
donation will be excluded.
The study will involve analyzing HPV DNA in semen samples through PCR, utilizing the most
effective method for HPV DNA detection previously identified in a pilot study. Sperm samples
collected during infertility investigations and IVF/ICSI treatments will undergo gradient
centrifugation to separate different components. A portion of the sperm sample will be
preserved for PCR analysis to detect HPV DNA, while the rest will be used for IVF/ICSI
procedures. The results from the PCR analyses will be correlated with semen characteristics
and the outcomes of IVF/ICSI treatment. Furthermore, the samples will be stored for potential
future analyses related to HPV-related biomarkers for up to 5 years at Biobank.
Description:
Infection with the human papillomavirus (HPV) represents one of the most widespread sexually
transmitted diseases, affecting both genders. Over 100 types of HPV can cause infections in
the skin or mucous membranes and are typically transmitted through skin-to-skin contact,
vaginal or anal intercourse, as well as oral sex. Statistics indicate that between 50 and 80
percent of sexually active adults will experience genital HPV infections during their
lifetime. These infections tend to be persistent, especially in men. Although most HPV
infections are asymptomatic, they can lead to genital warts, dysplasia, cancer, infertility,
and may impact the outcomes of in vitro fertilization (IVF). Despite extensive research on
HPV-related conditions in women, there has been limited attention given to HPV-related
conditions in men.
A systematic review and meta-analysis conducted in 2017, comprising 31 studies, revealed that
the prevalence of HPV DNA in semen samples among men in the general population was 11.4%,
rising to 20.4% among men with infertility. It remains unclear whether HPV localizes in
seminal plasma or in cellular fractions of semen samples (such as sperm, epithelial cells, or
leukocytes). Recent evidence has shown that HPV DNA can be found on the surface of sperm by
binding to specific glycosaminoglycans (GAGs), such as syndecan-1, along the equatorial
region of the sperm head. Additionally, a few in vitro studies have indicated that HPV DNA
can be found inside sperm when mixed with the HPV virus. The potential effects of HPV on
fertility are not yet fully understood. The presence of HPV infection in sperm has been
associated with impaired sperm parameters, mainly sperm motility, and increased sperm DNA
fragmentation. Existing evidence suggests a negative effect of HPV DNA in seminal plasma
and/or on sperm on the number of live births and ongoing pregnancies, although the level of
evidence remains limited. Considering that sperm is utilized in IVF, it is crucial to
investigate the presence of HPV in seminal plasma and sperm in these men, as well as any
potential consequences on embryo development following IVF.
The primary objective of this study is to assess the prevalence of HPV DNA in seminal plasma
and/or on sperm in men undergoing in vitro fertilization (IVF) or intracytoplasmic sperm
injection (ICSI) treatments. Furthermore, the study aims to characterize semen parameters in
men with HPV-positive (HPV+) and HPV-negative (HPV-) semen samples and analyze the
embryological outcomes after IVF/ICSI in men with HPV+ semen samples compared to men with
HPV- semen samples.
The secondary objectives include evaluating semen parameters such as volume, sperm
concentration, and motility to determine if there are differences between men with HPV+ and
HPV- semen samples. Additionally, the study aims to investigate whether the embryological
outcome (fertilization rate, number of high-quality embryos) after IVF/ICSI treatment differs
between men with HPV+ and HPV- semen samples.
Analyses of HPV DNA in seminal plasma and/or on sperm will be conducted using the method that
has demonstrated the highest performance in detecting HPV DNA, based on a previously
conducted pilot study. Sperm samples are typically provided at the Fertility Laboratory at
the Department of Reproductive Medicine, SU, in conjunction with infertility investigations
and IVF/ICSI treatments. Usually, up to 2 mL of ejaculated sperm sample undergo gradient
centrifugation, separating motile sperm from seminal plasma, immotile sperm, squamous
epithelial cells, leukocytes, and bacteria. A portion of the pellet containing motile sperm
is used to analyze sample parameters, primarily concentration and motility. During IVF/ICSI
treatments, parts of the sperm sample are utilized for egg fertilization while the remainder
is discarded. Following gradient centrifugation, sperm samples are diluted with a
preservation liquid (ThinPrep®, 1:2) and stored in a refrigerator for transport to the
Clinical Microbiology Department (virological laboratory) at SU (once per week) for
polymerase chain reaction (PCR) analysis. ThinPrep® is routinely used to preserve and fix
cell samples for HPV analysis in women. In this study, the portion of the sperm sample
typically discarded and not used for IVF treatment will be utilized for HPV DNA analysis
using PCR. PCR is the method routinely employed at the Clinical Microbiology Department
(virological laboratory) at SU for HPV DNA detection in cervical cell samples. Results from
these analyses will be correlated with sample parameters and the embryological outcome
following completed IVF/ICSI treatment. Once analyzed by PCR and upon the availability of
material, the samples will be stored for 5 years at Biobank Väst for potential future
analyses of HPV-related biomarkers.
