InfertilityPhase 2/3IntralipidNCT01540591
Intralipid for Repeated Implantation Failure
A Phase 2/3 study testing intralipid and Saline in people with Infertility, run by Cairo University at 1 site in Egypt.
Trial summary
Intralipid infusion can improve outcome in women with recurrent Intracytoplasmic sperm injection ( ICSI) failure due to elevated TH1 cytokine response. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- intralipid and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- Feb 2012to Jun 2014
- Phase
- Phase 2/3
- 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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Infertile patients undergoing ICSI cycle with history of repeated implantation failure
Who cannot join
- 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.
- Uterine fibroid, endometrial polyp, endometriosis and hydrosalpinx.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Intralipid Infusion Improve the Implantation Rate in Repeated Implantation Failure: a Randomized Controlled Trial
Intralipid infusion can improve outcome in women with recurrent Intracytoplasmic sperm injection ( ICSI) failure due to elevated TH1 cytokine response.
Read the detailed description
Infertile patients undergoing Intracytoplasmic Sperm Injection (ICSI) cycle with history of repeated implantation failure, intralipid will be given to the intervention group.
The primary outcome measure is the clinical pregnancy rate, secondary outcome measures implantation rate, ongoing pregnancy rate, abortion rate.
- Conditions
- Infertility
- Being tested
- intralipid, Saline
- Keywords
- repeated implantation failure, intralipid
- Medical subject headings
- Infertility
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% between day4 and 9 of ovarian stimulation \& another dose when got pregnant within the 1st week of positive pregnancy test
SalineDrug
Also called Saline 0.9%
Saline 0.9% IV infusion between day4 and 9 of ovarian stimulation \& another dose when got pregnant within the 1st week of positive pregnancy test
| Study group | Role | What they receive |
|---|---|---|
| control | Placebo comparator | Saline 0.9% IV infusion between day 4 and 9 of ovarian stimulation \& another dose when got pregnant within the 1st week of positive pregnancy test Receives: Drug: Saline |
| intralipid | Experimental | IV infusion of intralipid 20% between day4 and 9 of ovarian stimulation \& another dose when got pregnant within the 1st week of positive pregnancy test Receives: Drug: intralipid |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical pregnancy rate
pregancy sac with fetal heart activity
Measured: 10 month
Secondary outcomes (2)
implantation rate
the number of gestational sacs divided by the number of embryos transferred
Measured: 10 month
ongoing pregnancy rate
clinical pregnancy continue after 12 weeks gestational age
Measured: 14 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionSep 2013
- Study completionJun 2014
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.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Waleed El-khayat, Cairo University
- Investigators
- Waleed El-khayat, M.D., Principal investigator, Faculty of medicine, Cairo University, Cairo, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01540591
- Sponsor's protocol ID
- 22012
- Acronym
- Intralipid
- Status last verified
- Sep 2016
- First submitted
- 23 Feb 2012
- Last updated
- 16 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Intralipid Infusion Improve the Implantation Rate in Repeated Implantation Failure: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01540591
- Acronym / sponsor ID
- Intralipid / 22012
- Conditions
- Infertility
- Keywords
- repeated implantation failure, intralipid
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 29 Feb 2012 (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 outcome in women with recurrent Intracytoplasmic sperm injection ( ICSI) failure due to elevated TH1 cytokine response.
Detailed description
Infertile patients undergoing Intracytoplasmic Sperm Injection (ICSI) cycle with history of repeated implantation failure, intralipid will be given to the intervention group.
The primary outcome measure is the clinical pregnancy rate, secondary outcome measures implantation rate, ongoing pregnancy rate, abortion rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | Placebo comparator | Drug: SalineSaline 0.9% IV infusion between day 4 and 9 of ovarian stimulation \& another dose when got pregnant within the 1st week of positive pregnancy test |
| intralipid | Experimental | Drug: intralipidIV infusion of intralipid 20% between day4 and 9 of ovarian stimulation \& another dose when got pregnant within the 1st week of positive pregnancy test |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Infertile patients undergoing ICSI cycle with history of repeated implantation failure
Key exclusion criteria (4 listed)
- 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.
- 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 |
|---|---|---|
| intralipidAlso: intralipid 20%IV infusion of intralipid 20% between day4 and 9 of ovarian stimulation \& another dose when got pregnant within the 1st week of positive pregnancy test | Drug | intralipid |
| SalineAlso: Saline 0.9%Saline 0.9% IV infusion between day4 and 9 of ovarian stimulation \& another dose when got pregnant within the 1st week of positive pregnancy test | Drug | control |
Primary outcome
clinical pregnancy rate
Time frame: 10 month
pregancy sac with fetal heart activity
2 secondary outcomes
implantation rate
Time frame: 10 month
ongoing pregnancy rate
Time frame: 14 month
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 16 Sep 2016.
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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.
Waleed El-khayat, M.D. principal investigator
Faculty of medicine, Cairo University, Cairo, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing intralipid and Saline 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 4 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 16 Sep 2016. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 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?
clinical pregnancy rate (time frame: 10 month). 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 16 Sep 2016.