Intralipid for Recurrent Miscarriage

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2016-09-30

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.

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Detailed Description

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Conditions

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Abortion, Spontaneous Abortion, Habitual

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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

Group Type EXPERIMENTAL

Intralipid

Intervention Type DRUG

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

Control

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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intralipid 20%

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes