InfertilityNCT03666364
Magnetic Nanoparticle Sperm Separation for Teratozoospermia Male and Women Older Than 35 Years
A study testing Sperm preparation for ICSI in people with Infertility, run by Ibn Sina Hospital at 3 sites in Egypt.
Trial summary
Women over 35 years old are likely to suffer from impaired oocyte repair capacity. Teratozoospermia is a condition reflects morphological affection of sperm. These spermatozoa would add an extra burden on the oocyte after ICSI. Read more about this study
- Who is it for?
- Ages 35 to 42 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Sperm preparation for ICSI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,400 participants
- Where
- 3 sitesEgypt
- Study dates
- 17 Sep 2018to 1 Oct 2019
- 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 35 to 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- women indicated for ICSI but with teratozoospermia
Who cannot join
- Women not failing in this group
Trial locations and contacts
3 sites in 1 country.
Egypt3 sites
Banon Assiut
Asyut
Qena Fertility Center
Qina, Qena Governorate, 123456
IbnSina IVF Center
Sohag
About this study
Official title: Magnetic Nanoparticle Sperm Separation for ICSI Cycles With Teratozoospermia and Over 35 Years Old Women Age
Women over 35 years old are likely to suffer from impaired oocyte repair capacity. Teratozoospermia is a condition reflects morphological affection of sperm. These spermatozoa would add an extra burden on the oocyte after ICSI. Whether selecting mature sperm by magnetic nanoparticle protocol would provide a more competent sperm to a likely affected oocyte would improve ICSI outcomes is the question of this research.
- Conditions
- Infertility
- Being tested
- Sperm preparation for ICSI
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sperm preparation for ICSIOther
A new protocol for sperm preparation for ICSI cycles with teratozoospermia in over 35 years old women
| Study group | Role | What they receive |
|---|---|---|
| Magnetic nanoparticle selection for teratozoospermia | Experimental | Not described Receives: Other: Sperm preparation for ICSI |
| Density gradient centrifugation for teratozoospermia | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ongoing pregnancy rate
Measured: Twelve weeks of gestation
Secondary outcomes (1)
Embryo development after ICSI
Measured: Six days of culture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2018
- Study start17 Sep 2018
- Primary completion20 Sep 2019
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 1,400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ibn Sina Hospital
- Sponsor type
- Other government
- Collaborators
- Banon IVF Center Assiut, Egypt
- Responsible party
- Principal investigator, Muhammad Fawzy, Ibn Sina Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03666364
- Sponsor's protocol ID
- IbnSina-MNP
- Status last verified
- Nov 2019
- First submitted
- 9 Sep 2018
- Last updated
- 18 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Nanoparticle Sperm Separation for ICSI Cycles With Teratozoospermia and Over 35 Years Old Women Age
- ClinicalTrials.gov ID
- NCT03666364
- Acronym / sponsor ID
- IbnSina-MNP
- Conditions
- Infertility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,400 participants (actual)
- Lead sponsor
- Ibn Sina HospitalOther government
- Collaborators
- Banon IVF Center Assiut, Egypt
- Study start
- 17 Sep 2018 (actual)
- Primary completion
- 20 Sep 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 11 Sep 2018 (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.
Women over 35 years old are likely to suffer from impaired oocyte repair capacity. Teratozoospermia is a condition reflects morphological affection of sperm. These spermatozoa would add an extra burden on the oocyte after ICSI. Whether selecting mature sperm by magnetic nanoparticle protocol would provide a more competent sperm to a likely affected oocyte would improve ICSI outcomes is the question of this research.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magnetic nanoparticle selection for teratozoospermia | Experimental | Other: Sperm preparation for ICSI |
| Density gradient centrifugation for teratozoospermia | No intervention | – |
Who may qualify
- Ages
- 35 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- women indicated for ICSI but with teratozoospermia
Key exclusion criteria (1 listed)
- Women not failing in this group
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 preparation for ICSIA new protocol for sperm preparation for ICSI cycles with teratozoospermia in over 35 years old women | Other | Magnetic nanoparticle selection for teratozoospermia |
Primary outcome
Ongoing pregnancy rate
Time frame: Twelve weeks of gestation
1 secondary outcome
Embryo development after ICSI
Time frame: Six days of culture
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 18 Nov 2019.
- Individual participant dataSharing planned: No
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sperm preparation for ICSI in people with Infertility, run by Ibn Sina Hospital at 3 sites 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 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 18 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Ongoing pregnancy rate (time frame: Twelve weeks of gestation). 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 18 Nov 2019.