Male SubfertilityNCT06423989
Role of Immunoglobulin in Male Infertility
A study testing IVIG in people with Male Subfertility, run by Dr Salma kafeel Qureshi at 1 site in Pakistan.
Trial summary
to investigate the role of IVIG in male infertility and to determine its benefits in term of semen parameters and assisted reproduction outcome Read more about this study
- Who is it for?
- Any age, men onlyHealthy volunteers can take part
- Conditions the study is for
- Male Subfertility
- What is being tested?
- IVIG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Apr 2023to 1 Dec 2024
- Phase
- Interventional
- 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 Any age
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- male patients
Who cannot join
- female
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
SKMC
Islamabad, Capital, 44000
dr riffat, PhD
About this study
to investigate the role of IVIG in male infertility and to determine its benefits in term of semen parameters and assisted reproduction outcome
- Conditions
- Male Subfertility
- Being tested
- IVIG
- Medical subject headings
- Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVIGCombination product
Also called pentaglobin
treatment of subfertility
| Study group | Role | What they receive |
|---|---|---|
| male fertility | Experimental | Not described Receives: Combination Product: IVIG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Semen parameters percentage improvement
Sperm concentration/ml
Measured: 6 month
Sperm motility
Percentage active motile sperm
Measured: 6 month
Sperm morphology
Percentage of normal sperm
Measured: 6 month
Secondary outcomes (1)
Assisted Reproduction outcome measure
Percentage of fertilized
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2024
- Study start1 Apr 2023
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Male SubfertilityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr Salma kafeel Qureshi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr Salma kafeel Qureshi, Salma Kafeel Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06423989
- Sponsor's protocol ID
- 102023
- Status last verified
- May 2024
- First submitted
- 17 Apr 2024
- Last updated
- 21 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: with in 6 month
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Immunoglobulin in Male Infertility
- ClinicalTrials.gov ID
- NCT06423989
- Acronym / sponsor ID
- 102023
- Conditions
- Male Subfertility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Dr Salma kafeel QureshiUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 21 May 2024 (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.
to investigate the role of IVIG in male infertility and to determine its benefits in term of semen parameters and assisted reproduction outcome
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| male fertility | Experimental | Combination Product: IVIG |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- male patients
Key exclusion criteria (1 listed)
- female
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 |
|---|---|---|
| IVIGAlso: pentaglobintreatment of subfertility | Combination product | male fertility |
Primary outcome
Semen parameters percentage improvement
Time frame: 6 month
Sperm concentration/ml
Sperm motility
Time frame: 6 month
Percentage active motile sperm
Sperm morphology
Time frame: 6 month
Percentage of normal sperm
1 secondary outcome
Assisted Reproduction outcome measure
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
- Individual participant dataSharing planned: Yes. with in 6 month
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IVIG in people with Male Subfertility, run by Dr Salma kafeel Qureshi at 1 site in Pakistan.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 21 May 2024. 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 Pakistan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact DR Riffat, PhD (00923225041390, rifat.skmc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Semen parameters percentage improvement (time frame: 6 month). The study lists 3 primary outcomes in all. 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 21 May 2024.