Assessment of Intralipid Efficacy in Women With Unexplained Recurrent Implantation Failure (NCT02487940) | Clinical Trial Compass
CompletedPhase 4
Assessment of Intralipid Efficacy in Women With Unexplained Recurrent Implantation Failure
100 participantsStarted 2012-10
Plain-language summary
The study will include 100 women with unexplained recurrent implantation failure undergoing IVF/ICSI cycle.
Patients fulfilling the inclusion criteria will be randomised into two groups.
Study Group:
This group will include 50 women with unexplained recurrent implantation failure undergoing a trial of IVF/ICSI. This group will receive intravenous infusion of intralipid 20%, on the day of oocyte retrieval, a second dose on/ the following day of positive pregnancy test and a final dose 2-3 weeks later when attending for pregnancy scan.
Control Group:
This group will include 50 women with unexplained recurrent implantation failure undergoing a trial of IVF/ICSI. This group will receive intravenous infusion of placebo, on the day of oocyte retrieval, a second dose on/ the following day of positive pregnancy test and a final dose 2-3 weeks later when attending for pregnancy scan.
Who can participate
Age range
20 Years – 38 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 20-38 years of age.
* Repeated implantation failure with 3 or more failed IVF cycles with good quality embryos.
* Normal trans-vaginal ultrasonography.
* Normal hysteroscopy.
* Normal male and female karyotyping.
* Normal anti cardiolipin antibody IGG, IGM and Lupus anticoagulant.
* Normal thrombophilia screen in the form of protein c, s, anti thrombin iii and factor v leiden.
* Written and signed informed consent by the patient to participate in the study.
Exclusion Criteria:
* Age more than 38 years.
* Less than 3 failed IVF cycles.
* Poor embryo quality.
* Expected poor ovarian response.
* Abnormal trans-vaginal ultrasound findings e.g. endometrial polyps or fibroids.
* Abnormal male or female karyotyping.
* Abnormal hysteroscopic finding e.g. endometrial polyps, endometrial hyperplasia, fibroid or congenital anomalies.
* Positive Anticardiolipin antibodies or Lupus anticoagulant.
* Positive thrombophilia screen.
* Allergy to soy oil, eggs, peanut, peanut-based products or any active ingredient in the infusion.
* Mental condition rendering the patients unable to understand the nature, scope and possible consequences of the study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.