Intralipid for Recurrent Miscarriage

Woman's Health University Hospital, Egypt

Status and phase: Completed; Phase 4

Conditions: Abortion, Spontaneous; Abortion, Habitual

Treatments: Drug: Intralipid

Study type: Interventional

Funder types: Other

Identifiers

NCT01788540

12013

Details and patient eligibility

About

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

Enrollment: 300 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 2 patient groups

Intralipid

Experimental group

Description:

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

Treatment:

Drug: Intralipid

Control

No Intervention group

Description:

No intervention