Fertility IssuesNCT06156722
The Combination of Sperm Selection by IMSI and Hyaluronic Acid Binding Assay May Improve ICSI Outcome.
A study testing Sperm selection by IMSI and Sperm selection by IMSI and spermslow in people with Fertility Issues, run by Meir Medical Center at 1 site in Israel.
Trial summary
In this prospective randomized sibling-oocytes blinded study, investigators examine the combination of two sperm selection methods that logically seem to complete each other, and potentially may improve ICSI outcomes. Read more about this study
- Who is it for?
- Ages 18 to 38 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fertility Issues
- What is being tested?
- Sperm selection by IMSI and Sperm selection by IMSI and spermslow
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 189 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Mar 2019to 1 Feb 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 38 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- females ages 38 or younger retrieval of at least 5 mature oocytes and fresh ejaculate samples
Who cannot join
- frozen embryos surgically extracted sperm preparations embryo-biopsy cycles
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Combination of Sperm Selection by IMSI and Hyaluronic Acid Binding Assay Improves ICSI Outcomes: A Randomized Prospective Sibling-oocytes Study
In this prospective randomized sibling-oocytes blinded study, investigators examine the combination of two sperm selection methods that logically seem to complete each other, and potentially may improve ICSI outcomes.
The methods include the selection of the optimal spermatozoa based on its morphology by IMSI, together with its physiological function of binding to HA by Spermslow (SS).
The current study compared a group of ET after sperm selection by IMSI with SS to a group of ET after sperm selection by IMSI-only without SS, and to a mixed ET group where two embryos were transferred, one after IMSI-only and the other one after IMSI with SS.
- Conditions
- Fertility Issues
- Being tested
- Sperm selection by IMSI, Sperm selection by IMSI and spermslow
- Keywords
- IMSI, SpermSlow, Sperm selection, ICSI outcome, Sibling-oocytes study
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sperm selection by IMSIProcedure or surgery
Intracytoplasmic morphologically selected sperm injection (IMSI) is a sperm selection method used in intracytoplasmic sperm injection (ICSI)
Sperm selection by IMSI and spermslowProcedure or surgery
Intracytoplasmic morphologically selected sperm injection (IMSI) is a sperm selection method used in intracytoplasmic sperm injection (ICSI) + spermslow
| Study group | Role | What they receive |
|---|---|---|
| The IMSI-only group | Active comparator | The IMSI-only group Receives: Procedure: Sperm selection by IMSI |
| IMSI with SpermSlow group | Active comparator | IMSI with SpermSlow group Receives: Procedure: Sperm selection by IMSI and spermslow |
| Mixed embryo group | No intervention | Mixed embryo group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy and delivery rates
Pregnancy and delivery rates
Measured: Within up to 10 month from treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2023
- Study start1 Mar 2019
- Primary completion1 Feb 2024 (estimated)
- Study completion1 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fertility IssuesStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Assuta Medical Center, Tel Aviv University
- Responsible party
- Principal investigator, Yael Yagur, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06156722
- Sponsor's protocol ID
- MEIRIMSIRCT
- Status last verified
- Dec 2023
- First submitted
- 2 Nov 2023
- Last updated
- 19 Dec 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 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Combination of Sperm Selection by IMSI and Hyaluronic Acid Binding Assay Improves ICSI Outcomes: A Randomized Prospective Sibling-oocytes Study
- ClinicalTrials.gov ID
- NCT06156722
- Acronym / sponsor ID
- MEIRIMSIRCT
- Conditions
- Fertility Issues
- Keywords
- IMSI, SpermSlow, Sperm selection, ICSI outcome, Sibling-oocytes study
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 189 participants (actual)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Collaborators
- Assuta Medical Center, Tel Aviv University
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 5 Dec 2023 (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.
In this prospective randomized sibling-oocytes blinded study, investigators examine the combination of two sperm selection methods that logically seem to complete each other, and potentially may improve ICSI outcomes.
The methods include the selection of the optimal spermatozoa based on its morphology by IMSI, together with its physiological function of binding to HA by Spermslow (SS).
The current study compared a group of ET after sperm selection by IMSI with SS to a group of ET after sperm selection by IMSI-only without SS, and to a mixed ET group where two embryos were transferred, one after IMSI-only and the other one after IMSI with SS.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| The IMSI-only group | Active comparator | Procedure: Sperm selection by IMSIThe IMSI-only group |
| IMSI with SpermSlow group | Active comparator | Procedure: Sperm selection by IMSI and spermslowIMSI with SpermSlow group |
| Mixed embryo group | No intervention | –Mixed embryo group |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- females ages 38 or younger retrieval of at least 5 mature oocytes and fresh ejaculate samples
Key exclusion criteria (1 listed)
- frozen embryos surgically extracted sperm preparations embryo-biopsy cycles
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 |
|---|---|---|
| Sperm selection by IMSIIntracytoplasmic morphologically selected sperm injection (IMSI) is a sperm selection method used in intracytoplasmic sperm injection (ICSI) | Procedure or surgery | The IMSI-only group |
| Sperm selection by IMSI and spermslowIntracytoplasmic morphologically selected sperm injection (IMSI) is a sperm selection method used in intracytoplasmic sperm injection (ICSI) + spermslow | Procedure or surgery | IMSI with SpermSlow group |
Primary outcome
Pregnancy and delivery rates
Time frame: Within up to 10 month from treatment
Pregnancy and delivery rates
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 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.
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 Sperm selection by IMSI and Sperm selection by IMSI and spermslow in people with Fertility Issues, run by Meir Medical Center at 1 site in Israel.
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 19 Dec 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 Israel. 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?
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?
Pregnancy and delivery rates (time frame: Within up to 10 month from treatment). 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 19 Dec 2023.