InfertilityPhase 3NCT01916798
Intralipid Therapy for Women 35-40 Years With Positive Natural Killer Cells Undergoing Intracytoplasmic Sperm Injection (ICSI)
A Phase 3 study testing Intralipid infusion in people with Infertility, run by Cairo University at 1 site in Egypt.
Trial summary
Intralipid can suppress natural killer cells that are known to be involve in repeated implantation failure and recurrent miscarriages.Intralipid is made of purified soybean oil, egg phospholipids, glycerol and water. It provides essential fatty acids, linoleic acid, omega- 3 and 6 fatty acids and alpha-linolenic acid. Read more about this study
- Who is it for?
- Ages 35 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- Intralipid infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- May 2013to Feb 2015
- Phase
- Phase 3
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subfertile women aged 35-40 years with repeated implantation failure or recurrent miscarriage with positive natural killer cells undergoing Intracytoplasmic sperm injection (ICSI ) cycle.
Who cannot join
- women above 40years or less than 35 years
- Disturbances of normal fat metabolism such as pathologic hyperlipidemia,Lipoid nephrosis or acute pancreatitis with hyperlipidemia.
- Allergic to eggs, soybean oil, or safflower oil.
- Severe liver disease, kidney disease, lung disease, anemia, blood coagulation disorder.
- Uterine fibroid, endometrial polyp, endometriosis and hydrosalpinx.
- Antiphospholipid syndrome (lupus anticoagulant and/or anticardiolipin antibodies (Immunoglobulin G or M)[IgG or IgM]); other recognised thrombophilic conditions (testing according to usual clinic practice).
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- Intrauterine abnormalities (as assessed by ultrasound, hysterosonography, hysterosalpingogram, or hysteroscopy).
- Fibroids distorting uterine cavity.
- Abnormal parental karyotype.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intravenous Intralipid Therapy Among Women Aged 35-40 Years With Positive Peripheral Blood Natural Killer Cells Undergoing in Vitro Fertilization-Embryo Transfer: A Randomized Controlled Trial.
Intralipid can suppress natural killer cells that are known to be involve in repeated implantation failure and recurrent miscarriages.Intralipid is made of purified soybean oil, egg phospholipids, glycerol and water. It provides essential fatty acids, linoleic acid, omega- 3 and 6 fatty acids and alpha-linolenic acid. The effects of Intralipid in suppressing natural killer cell activity (NKa) were found to be comparable to intravenous immunoglobulin (IVIG) by laboratory experiments.We will study the effect of intralipid infusion on the pregnancy outcome of women aged 35-40 years with history of repeated implantation failure of miscarriage and who have positive peripheral blood natural killer cells
- Conditions
- Infertility
- Being tested
- Intralipid infusion
- Keywords
- Infertility, intralipid, invitro fertilization, repeated implantation failure, repeated miscarriage
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intralipid infusionDrug
IV infusion of 250 ml of intralipid 20% solution at the day of Ovum pick up \& another dose at the day of embryo Transfer.
| Study group | Role | What they receive |
|---|---|---|
| Intralipid infusion | Active comparator | 100 Subfertile women aged 35-40 years with repeated implantation failure or recurrent miscarriage with positive natural killer cells undergoing ICSI cycle. Receives: Drug: Intralipid infusion |
| Control group | No intervention | 100 Subfertile women aged 35-40 years with repeated implantation failure or recurrent miscarriage with positive natural killer cells undergoing ICSI cycle. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate
Intrauterine gestational sac with fatal pole and positive pulsation
Measured: 10 months
Secondary outcomes (5)
Chemical pregnancy
positive pregnancy test (serum BHCG) measured 16 days following embryo transfer
Measured: 10 months
implantation rate
the number of gestational sacs divided by the number of embryos transferred
Measured: 10 months
ongoing pregnancy rate
clinical pregnancy continue after 12 weeks gestational age
Measured: 10 months
Miscarriage rate
Measured: 12 months
Ectopic rate
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2013 (estimated)
- Study startMay 2013
- Primary completionJan 2015
- Study completionFeb 2015
Why it stopped: Not able to recruit the number required and due to financial difficulty to pay for intralipids
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Elkattan, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01916798
- Sponsor's protocol ID
- Protocol 300
- Status last verified
- Mar 2020
- First submitted
- 3 Aug 2013
- Last updated
- 1 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Coulam CB, Acacio B. Does immunotherapy for treatment of reproductive failure enhance live births? Am J Reprod Immunol. 2012 Apr;67(4):296-304. doi: 10.1111/j.1600-0897.2012.01111.x. Epub 2012 Feb 16.
PubMed 22340745Shreeve N, Sadek K. Intralipid therapy for recurrent implantation failure: new hope or false dawn? J Reprod Immunol. 2012 Jan;93(1):38-40. doi: 10.1016/j.jri.2011.11.003. Epub 2011 Dec 21.
PubMed 22196107
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Intralipid Therapy Among Women Aged 35-40 Years With Positive Peripheral Blood Natural Killer Cells Undergoing in Vitro Fertilization-Embryo Transfer: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT01916798
- Acronym / sponsor ID
- Protocol 300
- Conditions
- Infertility
- Keywords
- Infertility, intralipid, invitro fertilization, repeated implantation failure, repeated miscarriage
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not able to recruit the number required and due to financial difficulty to pay for intralipids
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- May 2013 (actual)
- Primary completion
- Jan 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 6 Aug 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 can suppress natural killer cells that are known to be involve in repeated implantation failure and recurrent miscarriages.Intralipid is made of purified soybean oil, egg phospholipids, glycerol and water. It provides essential fatty acids, linoleic acid, omega- 3 and 6 fatty acids and alpha-linolenic acid. The effects of Intralipid in suppressing natural killer cell activity (NKa) were found to be comparable to intravenous immunoglobulin (IVIG) by laboratory experiments.We will study the effect of intralipid infusion on the pregnancy outcome of women aged 35-40 years with history of repeated implantation failure of miscarriage and who have positive peripheral blood natural killer cells
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intralipid infusion | Active comparator | Drug: Intralipid infusion100 Subfertile women aged 35-40 years with repeated implantation failure or recurrent miscarriage with positive natural killer cells undergoing ICSI cycle. |
| Control group | No intervention | –100 Subfertile women aged 35-40 years with repeated implantation failure or recurrent miscarriage with positive natural killer cells undergoing ICSI cycle. |
Who may qualify
- Ages
- 35 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Subfertile women aged 35-40 years with repeated implantation failure or recurrent miscarriage with positive natural killer cells undergoing Intracytoplasmic sperm injection (ICSI ) cycle.
Key exclusion criteria (9 listed)
- women above 40years or less than 35 years
- Disturbances of normal fat metabolism such as pathologic hyperlipidemia,Lipoid nephrosis or acute pancreatitis with hyperlipidemia.
- Allergic to eggs, soybean oil, or safflower oil.
- Severe liver disease, kidney disease, lung disease, anemia, blood coagulation disorder.
- Uterine fibroid, endometrial polyp, endometriosis and hydrosalpinx.
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 |
|---|---|---|
| Intralipid infusionIV infusion of 250 ml of intralipid 20% solution at the day of Ovum pick up \& another dose at the day of embryo Transfer. | Drug | Intralipid infusion |
Primary outcome
Clinical pregnancy rate
Time frame: 10 months
Intrauterine gestational sac with fatal pole and positive pulsation
5 secondary outcomes
Chemical pregnancy
Time frame: 10 months
implantation rate
Time frame: 10 months
ongoing pregnancy rate
Time frame: 10 months
Miscarriage rate
Time frame: 12 months
Ectopic rate
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Not able to recruit the number required and due to financial difficulty to pay for intralipids). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2020.
- Background: PubMed 22340745Coulam CB, Acacio B. Does immunotherapy for treatment of reproductive failure enhance live births? Am J Reprod Immunol. 2012 Apr;67(4):296-304. doi: 10.1111/j.1600-0897.2012.01111.x. Epub 2012 Feb 16.
- Background: PubMed 22196107Shreeve N, Sadek K. Intralipid therapy for recurrent implantation failure: new hope or false dawn? J Reprod Immunol. 2012 Jan;93(1):38-40. doi: 10.1016/j.jri.2011.11.003. Epub 2011 Dec 21.
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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 Phase 3 study testing Intralipid infusion in people with Infertility, run by Cairo University 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 1 inclusion and 9 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: stopped early, as of the sponsor's last update on 1 Apr 2020. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: Not able to recruit the number required and due to financial difficulty to pay for intralipids). 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?
Clinical 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 NCT01916798, which also lists 2 linked publications.
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 1 Apr 2020.