Abortion, SpontaneousPhase 4NCT01788540
Intralipid for Recurrent Miscarriage
A Phase 4 study testing Intralipid in people with Abortion, Spontaneous and Abortion, Habitual, run by Woman's Health University Hospital, Egypt at 1 site in Egypt.
Trial summary
Intralipid infusion can improve the outcome in NK cells positive females with history of recurrent miscarriages undergoing IVF/ICSI cycles. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Abortion, Spontaneous, Abortion, Habitual
- What is being tested?
- Intralipid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- Feb 2013to Sep 2016
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Couples with unexplained secondary infertility
- Three or more prior consecutive clinical miscarriages after either spontaneous pregnancy or after IVF/ICSI.
- Elevated natural killer (NK) cells CD16, CD56 and cells with both CD16/CD56 >12%.
Who cannot join
- Age above forty years old.
- Antiphospholipid syndrome (lupus anticoagulant and/or anticardiolipin antibodies [IgG or IgM]); other recognised thrombophilic conditions (testing according to usual clinic practice).
- Intrauterine abnormalities (as assessed by ultrasound, hysterosonography, hysterosalpingogram, or hysteroscopy).
- Abnormal parental karyotype.
- Other identifiable causes of recurrent miscarriages (tests initiated only if clinically indicated) e.g., diabetes, thyroid disease and systemic lupus erythematosus (SLE).
- Disturbances of normal fat metabolism such as pathologic hyperlipemia
- Allergic to it; or to eggs, soybean oil, or safflower oil.
- Severe liver disease, kidney disease, lung disease, anemia, blood clotting disorder.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Intralipid in Natural Killer Cell Positive Cases With Recurrent Miscarriages Undergoing IVF/ICSI Cycles: a Double Blind Randomized Controlled Trial
Intralipid infusion can improve the outcome in NK cells positive females with history of recurrent miscarriages undergoing IVF/ICSI cycles.
- Conditions
- Abortion, Spontaneous, Abortion, Habitual
- Being tested
- Intralipid
- Keywords
- Recurrent miscarriage, Implantation failure, Intralipid, ICSI / IVF failure
- Medical subject headings
- Abortion, Spontaneous, 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 20%
IV infusion of intralipid 20% is administrated on the day of vaginal egg collection in a dose of 9 mg/ml total blood volume corresponding to intralipid 2 ml 20% diluted in 250 ml saline over 30-60 minutes.the intralipid infusion is then repeated within the 1st week of positive pregnancy test and every 2 weeks till end of first trimester
| Study group | Role | What they receive |
|---|---|---|
| Intralipid | Experimental | IV infusion of intralipid 20% is administrated on the day of vaginal egg collection in a dose of 9 mg/ml total blood volume corresponding to intralipid 2 ml 20% diluted in 250 ml saline over 30-60 minutes.
the intralipid infusion is then repeated within the one week of positive pregnancy test and every 2 weeks till end of first trimester Receives: Drug: Intralipid |
| Control | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
chemical pregnancy rate
Positive pregnancy test in blood as measured by quantitative B- hCG level
Measured: 10 months
Secondary outcomes (1)
clinical pregnancy rate,
Confirmed pregnancy at 7 weeks by ultrasound visualization of gestational sac and positive fetal pulsations
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionAug 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Abortion, SpontaneousStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Woman's Health University Hospital, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Mohamed Refaat Dakhly, Woman's Health University Hospital, Egypt
- Investigators
- Dina M Dakhly, M.D., Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01788540
- Sponsor's protocol ID
- 12013
- Status last verified
- Jan 2018
- First submitted
- 7 Feb 2013
- Last updated
- 26 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Dakhly DM, Bayoumi YA, Sharkawy M, Gad Allah SH, Hassan MA, Gouda HM, Hashem AT, Hatem DL, Ahmed MF, El-Khayat W. Intralipid supplementation in women with recurrent spontaneous abortion and elevated levels of natural killer cells. Int J Gynaecol Obstet. 2016 Dec;135(3):324-327. doi: 10.1016/j.ijgo.2016.06.026. Epub 2016 Aug 30.
PubMed 27614789
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Intralipid in Natural Killer Cell Positive Cases With Recurrent Miscarriages Undergoing IVF/ICSI Cycles: a Double Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01788540
- Acronym / sponsor ID
- 12013
- Conditions
- Abortion, Spontaneous, Abortion, Habitual
- Keywords
- Recurrent miscarriage, Implantation failure, Intralipid, ICSI / IVF failure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Woman's Health University Hospital, EgyptUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Aug 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 11 Feb 2013 (estimated)
- 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.
Intralipid infusion can improve the outcome in NK cells positive females with history of recurrent miscarriages undergoing IVF/ICSI cycles.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intralipid | Experimental | Drug: IntralipidIV infusion of intralipid 20% is administrated on the day of vaginal egg collection in a dose of 9 mg/ml total blood volume corresponding to intralipid 2 ml 20% diluted in 250 ml saline over 30-60 minutes. the intralipid infusion is then repeated within the one week of positive pregnancy test and every 2 weeks till end of first trimester |
| Control | No intervention | –No intervention |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Couples with unexplained secondary infertility
- Three or more prior consecutive clinical miscarriages after either spontaneous pregnancy or after IVF/ICSI.
- Elevated natural killer (NK) cells CD16, CD56 and cells with both CD16/CD56 >12%.
Key exclusion criteria (8 listed)
- Age above forty years old.
- Antiphospholipid syndrome (lupus anticoagulant and/or anticardiolipin antibodies [IgG or IgM]); other recognised thrombophilic conditions (testing according to usual clinic practice).
- Intrauterine abnormalities (as assessed by ultrasound, hysterosonography, hysterosalpingogram, or hysteroscopy).
- Abnormal parental karyotype.
- Other identifiable causes of recurrent miscarriages (tests initiated only if clinically indicated) e.g., diabetes, thyroid disease and systemic lupus erythematosus (SLE).
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 20%IV infusion of intralipid 20% is administrated on the day of vaginal egg collection in a dose of 9 mg/ml total blood volume corresponding to intralipid 2 ml 20% diluted in 250 ml saline over 30-60 minutes.the intralipid infusion is then repeated within the 1st week of positive pregnancy test and every 2 weeks till end of first trimester | Drug | Intralipid |
Primary outcome
chemical pregnancy rate
Time frame: 10 months
Positive pregnancy test in blood as measured by quantitative B- hCG level
1 secondary outcome
clinical pregnancy rate,
Time frame: 10 months
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 26 Jan 2018.
- Derived from this study: PubMed 27614789Dakhly DM, Bayoumi YA, Sharkawy M, Gad Allah SH, Hassan MA, Gouda HM, Hashem AT, Hatem DL, Ahmed MF, El-Khayat W. Intralipid supplementation in women with recurrent spontaneous abortion and elevated levels of natural killer cells. Int J Gynaecol Obstet. 2016 Dec;135(3):324-327. doi: 10.1016/j.ijgo.2016.06.026. Epub 2016 Aug 30.
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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.
Dina M Dakhly, M.D. principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intralipid in people with Abortion, Spontaneous and Abortion, Habitual, run by Woman's Health University Hospital, 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 3 inclusion and 8 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 26 Jan 2018. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
chemical pregnancy rate (time frame: 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01788540, which also lists 1 linked publication.
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 26 Jan 2018.