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NCT06161727
Detection and Prevalence of Human Papillomavirus (HPV) in Seminal Plasma and/or on Sperm in Men Undergoing Treatment With IVF/ICSI.
trial testing HPV exposure in Human Papilloma Virus in 260 participants. Completed in 28 March 2024.
30 January 2024
Quick facts
| Lead sponsor | Vastra Gotaland Region |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 260 |
| Start date | 1 January 2023 |
| Primary completion | 30 January 2024 |
| Estimated completion | 28 March 2024 |
| Sites | 1 location across Sweden |
Drugs / interventions tested
- HPV exposure
Conditions studied
- Human Papilloma Virus — all drugs for Human Papilloma Virus →
- Infertility, Male — all drugs for Infertility, Male →
Sponsor
Vastra Gotaland Region — full company profile →
Who can join
Adults 18 to 60, male only, with Human Papilloma Virus or Infertility, Male. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Semen HPV and IVF: insights from infection prevalence to embryologic outcomes.
Francis J, Tsiartas P, Hreinsson J, Andersson M, et al · · 2025 · PMID 40402400 · DOI 10.1007/s10815-025-03513-6
Verify or expand the search:
- PubMed search for NCT06161727
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Vastra Gotaland Region trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06161727 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Vastra Gotaland Region
- Last refreshed: 26 April 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06161727.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing