Intralipid infusion can improve the outcome in NK cells positive females with history of recurrent miscarriages undergoing IVF/ICSI cycles.
Full Title of Study: “The Role of Intralipid in Natural Killer Cell Positive Cases With Recurrent Miscarriages Undergoing IVF/ICSI Cycles: a Double Blind Randomized Controlled Trial”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Double (Participant, Investigator)
- Study Primary Completion Date: August 2016
- Drug: Intralipid
- 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
Arms, Groups and Cohorts
- Experimental: Intralipid
- 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
- No Intervention: Control
- No intervention
Clinical Trial Outcome Measures
- chemical pregnancy rate
- Time Frame: 10 months
- Positive pregnancy test in blood as measured by quantitative B- hCG level
- clinical pregnancy rate,
- Time Frame: 10 months
- Confirmed pregnancy at 7 weeks by ultrasound visualization of gestational sac and positive fetal pulsations
Participating in This Clinical Trial
- 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%.
- 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.
Gender Eligibility: Female
Minimum Age: 18 Years
Maximum Age: 40 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
- Lead Sponsor
- Woman’s Health University Hospital, Egypt
- Provider of Information About this Clinical Study
- Principal Investigator: Dina Mohamed Refaat Dakhly, M.D. – Woman’s Health University Hospital, Egypt
- Overall Official(s)
- Dina M Dakhly, M.D., Principal Investigator, Cairo University
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