Intralipid for Recurrent Miscarriage

Study Overview
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Brief Summary
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Intralipid infusion can improve the outcome in NK cells positive females with history of recurrent miscarriages undergoing IVF/ICSI cycles.

Official Title
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The Role of Intralipid in Natural Killer Cell Positive Cases With Recurrent Miscarriages Undergoing IVF/ICSI Cycles: a Double Blind Randomized Controlled Trial

Conditions
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Abortion, Spontaneous, Abortion, Habitual

Intervention / Treatment
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* Drug: Intralipid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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%. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intralipid<br>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 | Drug: Intralipid<br>* 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<br>* Other names: intralipid 20%;|
| No Intervention: Control<br>No intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| chemical pregnancy rate | Positive pregnancy test in blood as measured by quantitative B- hCG level | 10 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical pregnancy rate, | Confirmed pregnancy at 7 weeks by ultrasound visualization of gestational sac and positive fetal pulsations | 10 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Recurrent miscarriage, Implantation failure, Intralipid, ICSI / IVF failure