Intralipid for Recurrent Miscarriage

Phase 4

Completed

• Conditions: Abortion, Habitual; Abortion, Spontaneous
• Interventions: Drug: Intralipid

• Registration Number: NCT01788540
• Lead Sponsor: Woman's Health University Hospital, Egypt

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-02-07
• Study First Submitted QC: 2013-02-08
• Study First Posted: 2013-02-11
• Primary Completion: 2016-08
• Study Completion: 2016-09
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-24
• Last Update Posted: 2018-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intralipid	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

Primary Outcome Measures

Name	Time	Method
chemical pregnancy rate	10 months	Positive pregnancy test in blood as measured by quantitative B- hCG level

Secondary Outcome Measures

Name	Time	Method
clinical pregnancy rate,	10 months	Confirmed pregnancy at 7 weeks by ultrasound visualization of gestational sac and positive fetal pulsations

Trial Locations

Locations (1)

Kasr el ainy hospital; 🇪🇬 Cairo, Egypt