Recurrent MiscarriagePhase 1NCT03132779
Intralipid Related Effect on NKcells in Patients With Unexplained Recurrent Spontaneous Abortion
A Phase 1 study testing Intralipid in people with Recurrent Miscarriage, run by Ahmed Mohamed Bahaa Eldin Ahmed.
Trial summary
Evaluating the effect of intralipid on the natural killer cells 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
- Recurrent Miscarriage
- What is being tested?
- Intralipid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2017to 20 Feb 2018
- Phase
- Phase 1
- 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
- All women icluded having recurrent spontaneous abortions equal or more than twice.
- Alittle women having increased NKCELLS activity.
Who cannot join
- Any other diseases causing miscarriage as autoimmune (lupus erythematosus or antiphospholipid antibodies syndrome )or endocrinopathy (diabetes mellitus, thyroid disorders and hyperprolactinaemia)or thrombophilia (factor v leiden mutation, protein c or s deficiency, prothrombin G20210A mutation, antithrombin III deficiency ) or abnormal karyotyping to one or both of parents or previous history of hormonal contraception or intrauterine device usage at last 3 months or any contraindications for intralipid usage.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Intralipid Related Effect on NKcells in Patients With Unexplained Recurrent Spontaneous Abortions
Evaluating the effect of intralipid on the natural killer cells
Read the detailed description
This study will done on women with recurrent spontaneous abortions having increased NKCELLS activity and evaluate the effect of Intralipid on them after re-estimation of NKcells activity again after one week of Intralipid adminstration
- Conditions
- Recurrent Miscarriage
- Being tested
- Intralipid
- Keywords
- Intralipid, NK cells, Recurrent miscarriage
- Medical subject headings
- Abortion, Habitual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IntralipidDrug
Also called Intralipid 18 mg
Adose of intralipid given and rechecking NKcells activity
| Study group | Role | What they receive |
|---|---|---|
| One armed | Experimental | One group of patient will take Intralipid for all Receives: Drug: Intralipid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in NK cells activity after injection of intralipid
NK cells is measured before and after injection of intralipid and is noticed for change in activity
Measured: One week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2017
- Study start1 May 2017 (estimated)
- Primary completion20 Jan 2018 (estimated)
- Study completion20 Feb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent MiscarriageStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Women with unexplained recurrent spontaneous abortions having increased NKcells activity
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ahmed Mohamed Bahaa Eldin Ahmed
- Sponsor type
- University, hospital or other
- Collaborators
- Ain Shams Maternity Hospital
- Responsible party
- Sponsor-investigator, Ahmed Mohamed Bahaa Eldin Ahmed, Ain Shams Maternity Hospital
- Investigators
- Hassan T Khairy, Professor, Study director, Hassan Tawfik office
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03132779
- Sponsor's protocol ID
- Intralipid
- Status last verified
- Apr 2017
- First submitted
- 16 Apr 2017
- Last updated
- 28 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intralipid Related Effect on NKcells in Patients With Unexplained Recurrent Spontaneous Abortions
- ClinicalTrials.gov ID
- NCT03132779
- Acronym / sponsor ID
- Intralipid
- Conditions
- Recurrent Miscarriage
- Keywords
- Intralipid, NK cells, Recurrent miscarriage
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Ahmed Mohamed Bahaa Eldin AhmedUniversity, hospital or other
- Collaborators
- Ain Shams Maternity Hospital
- Study start
- 1 May 2017 (estimated)
- Primary completion
- 20 Jan 2018 (estimated)
- Study completion
- 20 Feb 2018 (estimated)
- First posted
- 28 Apr 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.
Evaluating the effect of intralipid on the natural killer cells
Detailed description
This study will done on women with recurrent spontaneous abortions having increased NKCELLS activity and evaluate the effect of Intralipid on them after re-estimation of NKcells activity again after one week of Intralipid adminstration
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Women with unexplained recurrent spontaneous abortions having increased NKcells activity
| Arm | Type | Receives |
|---|---|---|
| One armed | Experimental | Drug: IntralipidOne group of patient will take Intralipid for all |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- All women icluded having recurrent spontaneous abortions equal or more than twice.
- Alittle women having increased NKCELLS activity.
Key exclusion criteria (1 listed)
- Any other diseases causing miscarriage as autoimmune (lupus erythematosus or antiphospholipid antibodies syndrome )or endocrinopathy (diabetes mellitus, thyroid disorders and hyperprolactinaemia)or thrombophilia (factor v leiden mutation, protein c or s deficiency, prothrombin G20210A mutation, antithrombin III deficiency ) or abnormal karyotyping to one or both of parents or previous history of hormonal contraception or intrauterine device usage at last 3 months or any contraindications for intralipid usage.
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 |
|---|---|---|
| IntralipidAlso: Intralipid 18 mgAdose of intralipid given and rechecking NKcells activity | Drug | One armed |
Primary outcome
Change in NK cells activity after injection of intralipid
Time frame: One week
NK cells is measured before and after injection of intralipid and is noticed for change in activity
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2017.
- Individual participant dataSharing planned: Undecided
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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.
Hassan T Khairy, Professor study director
Hassan Tawfik office
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Intralipid in people with Recurrent Miscarriage, run by Ahmed Mohamed Bahaa Eldin Ahmed.
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 2 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 28 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Sobhy R Mohammed, MBBCH (01003815460 ext. 002, Garavandya@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in NK cells activity after injection of intralipid (time frame: One week). 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 28 Apr 2017.