TerminatedPhase 3

Intralipid Therapy for Women 35-40 Years With Positive Natural Killer Cells Undergoing Intracytoplasmic Sperm Injection (ICSI)

Stopped: Not able to recruit the number required and due to financial difficulty to pay for intralipids

Egypt200 participantsStarted 2013-05

Plain-language 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. 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

Who can participate

Age range

35 Years – 40 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: Subfertile women aged 35-40 years with repeated implantation failure or recurrent miscarriage with positive natural killer cells undergoing Intracytoplasmic sperm injection (ICSI ) cycle. Exclusion Criteria: * 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). * Intrauterine abnormalities (as assessed by ultrasound, hysterosonography, hysterosalpingogram, or hysteroscopy). * Fibroids distorting uterine cavity. * Abnormal parental karyotype.

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.

What they're measuring

Clinical pregnancy rate

Timeframe: 10 months

Trial details

NCT IDNCT01916798

SponsorCairo University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-01

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