Male InfertilityNCT07121530
Human Papilloma Virus In Male Infertility
An observational study of Male Infertility, run by South Valley University at 1 site in Egypt.
Trial summary
Infertility is a major health problem worldwide and is estimated to affect 8-12% of couples in the reproductive age group. Infertility affects both men and women. Male causes for infertility are found in 50% of these couples. HPV may infect the semen ,allowing it to affect male fertility in a variety of ways. Read more about this study
- Who is it for?
- Ages 23 to 53 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Male Infertility
- What is being tested?
- HPV infection in infertile males
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2023to 10 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 23 to 53 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: The study will be conducted (30)infertile males with genital wart ,control (20) attending the Dermatology, Venereology\& Andrology clinic in Qena University Hospital.
Who may be able to join
- Patients with at least 1 year of unprotected sexual intercourse without conception.
- Patients with genital warts
Who cannot join
- Hypergonadotropic/hypogonadotropic hypogonadism
- Azoospermia
- chromosome abnormalities
- undescended testis
- mumps orchitis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role Of Human Papilloma Virus In Male Infertility In Qena Government - Upper Egypt
Infertility is a major health problem worldwide and is estimated to affect 8-12% of couples in the reproductive age group.
Infertility affects both men and women. Male causes for infertility are found in 50% of these couples.
HPV may infect the semen ,allowing it to affect male fertility in a variety of ways.
Read the detailed description
WHO defines infertility as the inability to conceive after at least 12 months of regular, unprotected sexual intercourse.
Reduced male fertility can be the result of congenital and acquired urogenital abnormalities, infections of the male accessory glands, increased scrotal temperature (varicocele), endocrine disturbances, genetic abnormalities and immunological factors ,
In 40-60% of cases the only abnormality is the semen analysis and there is no relevant history or abnormality on physical examination and endocrine laboratory testing (idiopathic male infertility).
Semen analysis reveals a decreased number of spermatozoa (oligozoospermia), decreased motility (asthenozoospermia) and many abnormal forms on morphological examination (teratozoospermia). Usually, these abnormalities come together and are described as the OAT-syndrome (oligo-astheno-teratozoospermia).
Human papillomavirus (HPV) is one of the most common sexually transmitted viruses, and males and females from different regions are generally susceptible.
More than 120 HPV genotypes are known to distribute in the skin and mucous membranes, including the pubic area, oral cavity and perianal region, and can be transmitted through skin contact or any other surface contact related to the genital area.
- Conditions
- Male Infertility
- Being tested
- HPV infection in infertile males
- Medical subject headings
- Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPV infection in infertile malesProcedure or surgery
Also called infertile males
To investigate the status of HPV infection in infertile males in Qena government, and to Analyse the effects of HPV infection on semen parameters.
| Study group | Role | What they receive |
|---|---|---|
| Infertile Males Group | About 30 infertile males with genital wart Receives: Procedure: HPV infection in infertile males | |
| Control Group | About 20 healthy males Receives: Procedure: HPV infection in infertile males |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigation of Human Papilloma Virus infection in infertile males
Investigation of Human Papilloma Virus (HPV) infection in infertile males as : all participants in the study made semen analysis and the semen were collected by masturbation after 5-7 days of abstinence. Semen parameters (semen volume, sperm concentration, progressive motility (PR) and rate of normal sperm morphology) were analyzed in a thermostat console after semen liquefaction. then Seminal Detection of HPV antibodies in infertile male by HPV ELISA Kit and also to see its effects on semen parameters in Qena government.
Measured: 2 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start1 Aug 2023
- Primary completion1 Aug 2024
- Study completion10 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Male InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Abderlraheem Abdellatif, South Valley University
- Investigators
- Eisa Mohammed Hegazy, Professor, Study chair, Dermatology, Venereology and Andrology. Faculty of Medicine,South ValleyUniversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07121530
- Sponsor's protocol ID
- SVU-MED-DVA021-1-23-8-706
- Status last verified
- Aug 2023
- First submitted
- 30 Jul 2025
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role Of Human Papilloma Virus In Male Infertility In Qena Government - Upper Egypt
- ClinicalTrials.gov ID
- NCT07121530
- Acronym / sponsor ID
- SVU-MED-DVA021-1-23-8-706
- Conditions
- Male Infertility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 10 Aug 2024 (actual)
- First posted
- 13 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Infertility is a major health problem worldwide and is estimated to affect 8-12% of couples in the reproductive age group.
Infertility affects both men and women. Male causes for infertility are found in 50% of these couples.
HPV may infect the semen ,allowing it to affect male fertility in a variety of ways.
Detailed description
WHO defines infertility as the inability to conceive after at least 12 months of regular, unprotected sexual intercourse.
Reduced male fertility can be the result of congenital and acquired urogenital abnormalities, infections of the male accessory glands, increased scrotal temperature (varicocele), endocrine disturbances, genetic abnormalities and immunological factors ,
In 40-60% of cases the only abnormality is the semen analysis and there is no relevant history or abnormality on physical examination and endocrine laboratory testing (idiopathic male infertility).
Semen analysis reveals a decreased number of spermatozoa (oligozoospermia), decreased motility (asthenozoospermia) and many abnormal forms on morphological examination (teratozoospermia). Usually, these abnormalities come together and are described as the OAT-syndrome (oligo-astheno-teratozoospermia).
Human papillomavirus (HPV) is one of the most common sexually transmitted viruses, and males and females from different regions are generally susceptible.
More than 120 HPV genotypes are known to distribute in the skin and mucous membranes, including the pubic area, oral cavity and perianal region, and can be transmitted through skin contact or any other surface contact related to the genital area.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infertile Males Group | – | Procedure: HPV infection in infertile malesAbout 30 infertile males with genital wart |
| Control Group | – | Procedure: HPV infection in infertile malesAbout 20 healthy males |
Who may qualify
- Ages
- 23 to 53 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study will be conducted (30)infertile males with genital wart ,control (20) attending the Dermatology, Venereology\& Andrology clinic in Qena University Hospital.
Key inclusion criteria (2 listed)
- Patients with at least 1 year of unprotected sexual intercourse without conception.
- Patients with genital warts
Key exclusion criteria (5 listed)
- Hypergonadotropic/hypogonadotropic hypogonadism
- Azoospermia
- chromosome abnormalities
- undescended testis
- mumps orchitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HPV infection in infertile malesAlso: infertile malesTo investigate the status of HPV infection in infertile males in Qena government, and to Analyse the effects of HPV infection on semen parameters. | Procedure or surgery | Control Group, Infertile Males Group |
Primary outcome
Investigation of Human Papilloma Virus infection in infertile males
Time frame: 2 Days
Investigation of Human Papilloma Virus (HPV) infection in infertile males as : all participants in the study made semen analysis and the semen were collected by masturbation after 5-7 days of abstinence. Semen parameters (semen volume, sperm concentration, progressive motility (PR) and rate of normal sperm morphology) were analyzed in a thermostat console after semen liquefaction. then Seminal Detection of HPV antibodies in infertile male by HPV ELISA Kit and also to see its effects on semen parameters in Qena government.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
Related trials for Male Infertility
Active, not recruitingObservational study
Retrieval of Sperm From Men With Azoospermia Using Ultrasound-guided Rete Testis Aspiration
Azoospermia, Nonobstructive, Infertility, Male
Not yet recruitingPhase 3
Comparative Study of Post-Varicocelectomy Myo-inositol vs. Antioxidants vs. Surgery Alone in Infertile Men
Myo-inositol, Post Varicocelectomy
Not yet recruitingPhase 2
PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
Endometriosis Pelvic, Endometriosis Ovaries
Not yet recruiting
Sperm, Exposure and Endocrine Disruptors
Fertility, Male Fertility
RecruitingObservational study
Inherited Reproductive Disorders
Genetic Disorder, Infertility
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eisa Mohammed Hegazy, Professor study chair
Dermatology, Venereology and Andrology. Faculty of Medicine,South ValleyUniversity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Male Infertility, run by South Valley University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigation of Human Papilloma Virus infection in infertile males (time frame: 2 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2025.