Infertility, MaleNCT05597631
G-IVF and Sperm Parameters
A study testing G-IVF PLUS in people with Infertility, Male, run by Vitrolife at 1 site in Greece.
Trial summary
The aim of this study is to investigate if adding a fixed volume of a physiological solution to a freshly produced sperm sample will affect sperm characteristics. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men only
- Conditions the study is for
- Infertility, Male
- What is being tested?
- G-IVF PLUS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteGreece
- Study dates
- Oct 2023to Apr 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 18 to 55 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Patients producing a pre-clinical semen sample at the clinic
Who cannot join
- Patients with known azoospermia
- Patients who have had a vasectomy
Trial locations and contacts
1 site in 1 country.
Greece1 site
IASO Maternity and Gynecology Clinic
Marousi, 151 23
Alexandra Spyrou, +302106184030, alex.spy.17@gmail.com
Eftychia Sklavolia
About this study
Official title: Does Adding Medium to Fresh Semen Samples Increase Motility After Preparation?
The aim of this study is to investigate if adding a fixed volume of a physiological solution to a freshly produced sperm sample will affect sperm characteristics.
- Conditions
- Infertility, Male
- Being tested
- G-IVF PLUS
- Keywords
- Sperm motility, Sperm preparation, Osmolarity
- Medical subject headings
- Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
G-IVF PLUSDevice
Experimental
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Control |
| G-IVF PLUS | Experimental | G-IVF PLUS Receives: Device: G-IVF PLUS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of progressive motile sperm (%)
Proportion of progressive motile sperm after sample preparation
Measured: 10 minutes of assessment will be used to count the motile sperm for each sample.
Secondary outcomes (1)
Sperm yield (%)
Percentage of total number of motile sperm after sperm preperation
Measured: 10 minutes used to assess motilty (as for primary outcome)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2022
- Study startOct 2023 (estimated)
- Primary completionMar 2024 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, MaleStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vitrolife
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05597631
- Sponsor's protocol ID
- 2022-GR-GIVFSP
- Status last verified
- Aug 2023
- First submitted
- 24 Oct 2022
- Last updated
- 30 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Adding Medium to Fresh Semen Samples Increase Motility After Preparation?
- ClinicalTrials.gov ID
- NCT05597631
- Acronym / sponsor ID
- 2022-GR-GIVFSP
- Conditions
- Infertility, Male
- Keywords
- Sperm motility, Sperm preparation, Osmolarity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- VitrolifeIndustry (pharma, biotech, devices)
- Study start
- Oct 2023 (estimated)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 28 Oct 2022 (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.
The aim of this study is to investigate if adding a fixed volume of a physiological solution to a freshly produced sperm sample will affect sperm characteristics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Control |
| G-IVF PLUS | Experimental | Device: G-IVF PLUSG-IVF PLUS |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients producing a pre-clinical semen sample at the clinic
Key exclusion criteria (2 listed)
- Patients with known azoospermia
- Patients who have had a vasectomy
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 |
|---|---|---|
| G-IVF PLUSExperimental | Device | G-IVF PLUS |
Primary outcome
Proportion of progressive motile sperm (%)
Time frame: 10 minutes of assessment will be used to count the motile sperm for each sample.
Proportion of progressive motile sperm after sample preparation
1 secondary outcome
Sperm yield (%)
Time frame: 10 minutes used to assess motilty (as for primary outcome)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
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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 G-IVF PLUS in people with Infertility, Male, run by Vitrolife at 1 site in Greece.
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 2 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 30 Aug 2023. 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 Greece. 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 Susanna Apter, PhL (+46701648828, sapter@vitrolife.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of progressive motile sperm (%) (time frame: 10 minutes of assessment will be used to count the motile sperm for each sample.). 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 30 Aug 2023.