Assisted Reproductive TechnologyNCT05113225
Sperm Micro-swim up Technique; Process and Select in the Same Dish: a Sibling-oocyte-split Design
A study testing Micro-swim up technique in people with Assisted Reproductive Technology and Infertility, run by Royal Fertility Center, Egypt at 1 site in Egypt.
Trial summary
A sibling-Oocyte-split design will be conducted on oocytes before denudation and divided into two groups : control group (MII oocytes will be injected using sperm processed by Density gradient method) and sample group ( MII oocytes will be injected by sperm processed using micro-swim up technique) Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Assisted Reproductive Technology, Infertility
- What is being tested?
- Micro-swim up technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Oct 2021to 30 Dec 2021
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- The normal \& high responders were selected according to :
- age: 18 - 40 years
- anti-Müllerian hormone (AMH): > 1.0 ng/ml
- number of aspirated oocytes:more than or equal 8
- BMI < 34
Who cannot join
- Age > 40 years;
- AMH < 1.0 ng/mL;
- aspirated oocytes < 8.
- severe male factor
- Testicular aspirated sperm
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sperm Micro-swim up; a Novel Technique to Process and Select in the Same Dish:a Sibling-oocyte-split Design)
A sibling-Oocyte-split design will be conducted on oocytes before denudation and divided into two groups : control group (MII oocytes will be injected using sperm processed by Density gradient method) and sample group ( MII oocytes will be injected by sperm processed using micro-swim up technique)
Read the detailed description
In This study investigators compare a novel sperm processing and selection method which is (fast, cheap and safe) with the well known processing method of sperm "Density gradient (DG)"
The dishes will be prepared with droplets of handling medium for oocytes (droplet volume 10 μL), and an H pattern using PVP will be produced, finally, all the droplets will be overlaid with mineral oil.
Control group : Oocytes will be injected using sperm after processing with DG and will be selected from control PVP microdroplets
Sample group: Sperm will be directly loaded in specific ICSI dishes where is the PVP microdroplets is prepared on "H" Pattern and will be selected from the far point from the deposition point and will be injected into the oocytes from the sample group All injected MII oocytes from both groups will then be cultured, with each group demarcated in separate place in the culture dish then according to the randomisation embryo transfer will be selected from one of both groups then the quality of the embryos will be reported and the pregnancy rate
- Conditions
- Assisted Reproductive Technology, Infertility
- Being tested
- Micro-swim up technique
- Keywords
- Sperm, micro-swim up, ICSI, Semen processing, density gradient
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micro-swim up techniqueProcedure or surgery
processing and selection of the sperm for ICSI in the same dish
| Study group | Role | What they receive |
|---|---|---|
| DG-ICSI | Active comparator | Oocytes of this arm will be injected using sperm previously processed by DG method and located in the commonly used ICSI dishes with the common PVP microdroplets Receives: Procedure: Micro-swim up technique |
| H pattern-ICSI | Experimental | Oocytes of this arm will be injected using sperm that directly located in a specific H pattern PVP droplets in a commonly used ICSI dishes without pre-processing of the semen Receives: Procedure: Micro-swim up technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of top quality embryos
the number of best embryos in each arm in Day 4 or Day 5
Measured: 4 or 5 days after ICSI procedure day
Secondary outcomes (2)
Early Cleavage rate
The early cleavage rate of oocytes from overall injected oocytes
Measured: 2 days after ICSI procedure day
chemical pregnancy rate
the quantitative serum HCG level that indicates positive pregnancy test for cases from over all cases
Measured: 14 days after embryo transfer day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study start10 Oct 2021
- Primary completion25 Dec 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Assisted Reproductive TechnologyStudies 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
- Single group
- Model description
- Single group of patients will be recruited in the study and each patient's oocytes will be divided into two groups and each group of patients will be injected with sperm processed by normal DG or H pattern micro- swim up technique. The PVP was used to produce the H pattern (length of about 2 cm from one side of the plate to the middle of the disk, total volume 10 μL). A small amount of semen (3 μL) was placed on one side of the H, and some time was allowed for it to migrate to the other side where the sperm was then collected. The dishes were incubated for three minutes allowing sperm migration along the outer perimeter of the H. After the completion of sperm migration, the plate was turned before the upload to avoid the contamination of the injection pipette by the sample.The injection pipette was introduced into the H-ICSI™ and used to immobilize a single sperm by crushing the membrane of its tail.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Fertility Center, Egypt
- Sponsor type
- University, hospital or other
- Collaborators
- Hawaa Fertility Center
- Responsible party
- Sponsor
- Investigators
- Sahar SA Eissa, PHD, Study director, research team leaderEngy EA Abdallah, MSC, Study chair, investigator & researcher
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05113225
- Sponsor's protocol ID
- 002
- Status last verified
- Oct 2021
- First submitted
- 8 Oct 2021
- Last updated
- 23 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study protocols and outcome
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sperm Micro-swim up; a Novel Technique to Process and Select in the Same Dish:a Sibling-oocyte-split Design)
- ClinicalTrials.gov ID
- NCT05113225
- Acronym / sponsor ID
- 002
- Conditions
- Assisted Reproductive Technology, Infertility
- Keywords
- Sperm, micro-swim up, ICSI, Semen processing, density gradient
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Royal Fertility Center, EgyptUniversity, hospital or other
- Collaborators
- Hawaa Fertility Center
- Study start
- 10 Oct 2021 (actual)
- Primary completion
- 25 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 9 Nov 2021 (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.
A sibling-Oocyte-split design will be conducted on oocytes before denudation and divided into two groups : control group (MII oocytes will be injected using sperm processed by Density gradient method) and sample group ( MII oocytes will be injected by sperm processed using micro-swim up technique)
Detailed description
In This study investigators compare a novel sperm processing and selection method which is (fast, cheap and safe) with the well known processing method of sperm "Density gradient (DG)"
The dishes will be prepared with droplets of handling medium for oocytes (droplet volume 10 μL), and an H pattern using PVP will be produced, finally, all the droplets will be overlaid with mineral oil.
Control group : Oocytes will be injected using sperm after processing with DG and will be selected from control PVP microdroplets
Sample group: Sperm will be directly loaded in specific ICSI dishes where is the PVP microdroplets is prepared on "H" Pattern and will be selected from the far point from the deposition point and will be injected into the oocytes from the sample group All injected MII oocytes from both groups will then be cultured, with each group demarcated in separate place in the culture dish then according to the randomisation embryo transfer will be selected from one of both groups then the quality of the embryos will be reported and the pregnancy rate
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Single group of patients will be recruited in the study and each patient's oocytes will be divided into two groups and each group of patients will be injected with sperm processed by normal DG or H pattern micro- swim up technique. The PVP was used to produce the H pattern (length of about 2 cm from one side of the plate to the middle of the disk, total volume 10 μL). A small amount of semen (3 μL) was placed on one side of the H, and some time was allowed for it to migrate to the other side where the sperm was then collected. The dishes were incubated for three minutes allowing sperm migration along the outer perimeter of the H. After the completion of sperm migration, the plate was turned before the upload to avoid the contamination of the injection pipette by the sample.The injection pipette was introduced into the H-ICSI™ and used to immobilize a single sperm by crushing the membrane of its tail.
| Arm | Type | Receives |
|---|---|---|
| DG-ICSI | Active comparator | Procedure: Micro-swim up techniqueOocytes of this arm will be injected using sperm previously processed by DG method and located in the commonly used ICSI dishes with the common PVP microdroplets |
| H pattern-ICSI | Experimental | Procedure: Micro-swim up techniqueOocytes of this arm will be injected using sperm that directly located in a specific H pattern PVP droplets in a commonly used ICSI dishes without pre-processing of the semen |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- The normal \& high responders were selected according to :
Key exclusion criteria (5 listed)
- Age > 40 years;
- AMH < 1.0 ng/mL;
- aspirated oocytes < 8.
- severe male factor
- Testicular aspirated sperm
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 |
|---|---|---|
| Micro-swim up techniqueprocessing and selection of the sperm for ICSI in the same dish | Procedure or surgery | DG-ICSI, H pattern-ICSI |
Primary outcome
Number of top quality embryos
Time frame: 4 or 5 days after ICSI procedure day
the number of best embryos in each arm in Day 4 or Day 5
2 secondary outcomes
Early Cleavage rate
Time frame: 2 days after ICSI procedure day
chemical pregnancy rate
Time frame: 14 days after embryo transfer day
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 23 Jun 2022.
- Individual participant dataSharing planned: No. Study protocols and outcome
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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.
Sahar SA Eissa, PHD study director
research team leader
Engy EA Abdallah, MSC study chair
investigator & researcher
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Micro-swim up technique in people with Assisted Reproductive Technology and Infertility, run by Royal Fertility Center, Egypt 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 5 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 23 Jun 2022. 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?
Number of top quality embryos (time frame: 4 or 5 days after ICSI procedure day). 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 23 Jun 2022.