Infertility, FemaleNCT03186170
Comparison of in Vitro Fertilization Rates of Oocytes and Embryo Development Using Two Techniques of Semen Processing
A study testing SSA sperm selection in people with Infertility, Female, run by University of Campinas, Brazil at 1 site in Brazil.
Trial summary
The investigators propose to assess one method of sperm selection based on the characteristics of spermatozoa recently introduced: Sperm Selection Assay, which used a gradient of concentration of progesterone to act as chemoatractant of spermatozoa of better quality. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Female
- What is being tested?
- SSA sperm selection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jun 2017to 15 Jul 2017
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- infertile women who will partcipate in an IVF programme
Who cannot join
- male factor of infertility
Trial locations and contacts
1 site in 1 country.
About this study
The investigators propose to assess one method of sperm selection based on the characteristics of spermatozoa recently introduced: Sperm Selection Assay, which used a gradient of concentration of progesterone to act as chemoatractant of spermatozoa of better quality. We will assess in vitro fertilization with two techniques (SSSA versus traditional technique of swin up) as well as embryo development.
Read the detailed description
The project is a RCT follow the orientation of CONSORT. The investigators propose to assess one method of sperm selection based on the characteristics of spermatozoa recently introduced: Sperm Selection Assay, which used a gradient of concentration of progesterone to act as chemoatractant of spermatozoa of better quality. We will assess in vitro fertilization with two techniques (SSSA versus traditional technique of swin up) as well as embryo development.
- Conditions
- Infertility, Female
- Being tested
- SSA sperm selection
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SSA sperm selectionOther
The investigators propose to assess one method of sperm selection based on the characteristics of spermatozoa recently introduced: Sperm Selection Assay, which used a gradient of concentration of progesterone to act as chemoatractant of spermatozoa of better quality. We will assess in vitro fertilization with two techniques (SSSA versus traditional technique of swin up) as well as embryo development.
| Study group | Role | What they receive |
|---|---|---|
| SSA | Experimental | The investigators propose to assess one method of sperm selection based on the characteristics of spermatozoa recently introduced: Sperm Selection Assay, which used a gradient of concentration of progesterone to act as chemoatractant of spermatozoa of better quality. We will assess in vitro fertilization with two techniques (SSA versus traditional technique of swin up) as well as embryo development.
In this arm, the sperm selection for IVF will be performed by the new proposed technique of Sperm Selection Assay which consist to expose spermatozoa a progesterone quemoatractant Sperm selection via SSA technique Receives: Other: SSA sperm selection |
| control | Active comparator | The investigators propose to assess one method of sperm selection based on the characteristics of spermatozoa recently introduced: Sperm Selection Assay, which used a gradient of concentration of progesterone to act as chemoatractant of spermatozoa of better quality. We will assess in vitro fertilization with two techniques (SSSA versus traditional technique of swin up for sperm selection) as well as embryo development.
In this arm, the sperm selection for IVF will be the traditional swin up technique with different Percoll gradient Sperm selection via traditional swin-up Receives: Other: SSA sperm selection |
What is being measured
The primary outcome is the main question the study is designed to answer.
In vitro fertilization: Rate of embryo fertilizated
we will asses the rate of embryo fertilizated
Measured: two weeks
Secondary outcomes (1)
Embryo development after IVF: Rate of embryo development
we will asses the rate of embryo development
Measured: two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start1 Jun 2017
- Primary completion15 Jul 2017
- Study completion15 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies 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
- Model description
- We propose to assess one method of sperm selection based on the characteristics of spermatozoa recently introduced: Sperm Selection Assay, which used a gradient of concentration of progesterone to act as chemoatractant of spermatozoa of better quality. We will assess in vitro fertilization with two techniques (SSSA versus traditional technique of swin up) as well as embryo development.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campinas, Brazil
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luis Bahamondes, University of Campinas, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03186170
- Sponsor's protocol ID
- Unicamp/2016/LB
- Status last verified
- Jul 2017
- First submitted
- 22 May 2017
- Last updated
- 25 Jul 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of in Vitro Fertilization Rates of Oocytes and Embryo Development Using Two Techniques of Semen Processing
- ClinicalTrials.gov ID
- NCT03186170
- Acronym / sponsor ID
- Unicamp/2016/LB
- Conditions
- Infertility, Female
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 15 Jul 2017 (actual)
- Study completion
- 15 Jul 2017 (actual)
- First posted
- 14 Jun 2017 (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 investigators propose to assess one method of sperm selection based on the characteristics of spermatozoa recently introduced: Sperm Selection Assay, which used a gradient of concentration of progesterone to act as chemoatractant of spermatozoa of better quality. We will assess in vitro fertilization with two techniques (SSSA versus traditional technique of swin up) as well as embryo development.
Detailed description
The project is a RCT follow the orientation of CONSORT. The investigators propose to assess one method of sperm selection based on the characteristics of spermatozoa recently introduced: Sperm Selection Assay, which used a gradient of concentration of progesterone to act as chemoatractant of spermatozoa of better quality. We will assess in vitro fertilization with two techniques (SSSA versus traditional technique of swin up) as well as embryo development.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- We propose to assess one method of sperm selection based on the characteristics of spermatozoa recently introduced: Sperm Selection Assay, which used a gradient of concentration of progesterone to act as chemoatractant of spermatozoa of better quality. We will assess in vitro fertilization with two techniques (SSSA versus traditional technique of swin up) as well as embryo development.
| Arm | Type | Receives |
|---|---|---|
| SSA | Experimental | Other: SSA sperm selectionThe investigators propose to assess one method of sperm selection based on the characteristics of spermatozoa recently introduced: Sperm Selection Assay, which used a gradient of concentration of progesterone to act as chemoatractant of spermatozoa of better quality. We will assess in vitro fertilization with two techniques (SSA versus traditional technique of swin up) as well as embryo development. In this arm, the sperm selection for IVF will be performed by the new proposed technique of Sperm Selection Assay which consist to expose spermatozoa a progesterone quemoatractant Sperm selection via SSA technique |
| control | Active comparator | Other: SSA sperm selectionThe investigators propose to assess one method of sperm selection based on the characteristics of spermatozoa recently introduced: Sperm Selection Assay, which used a gradient of concentration of progesterone to act as chemoatractant of spermatozoa of better quality. We will assess in vitro fertilization with two techniques (SSSA versus traditional technique of swin up for sperm selection) as well as embryo development. In this arm, the sperm selection for IVF will be the traditional swin up technique with different Percoll gradient Sperm selection via traditional swin-up |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- infertile women who will partcipate in an IVF programme
Key exclusion criteria (1 listed)
- male factor of infertility
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 |
|---|---|---|
| SSA sperm selectionThe investigators propose to assess one method of sperm selection based on the characteristics of spermatozoa recently introduced: Sperm Selection Assay, which used a gradient of concentration of progesterone to act as chemoatractant of spermatozoa of better quality. We will assess in vitro fertilization with two techniques (SSSA versus traditional technique of swin up) as well as embryo development. | Other | SSA, control |
Primary outcome
In vitro fertilization: Rate of embryo fertilizated
Time frame: two weeks
we will asses the rate of embryo fertilizated
1 secondary outcome
Embryo development after IVF: Rate of embryo development
Time frame: two weeks
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 25 Jul 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SSA sperm selection in people with Infertility, Female, run by University of Campinas, Brazil at 1 site in Brazil.
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: finished, as of the sponsor's last update on 25 Jul 2017. 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 Brazil. 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?
In vitro fertilization: Rate of embryo fertilizated (time frame: two weeks). 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 25 Jul 2017.