Intralipid Therapy for Women 35-40 Years With Positive Natural Killer Cells Undergoing Intracytoplasmic Sperm Injection (ICSI)

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

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2015-02-28

Brief Summary

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Intralipid can suppress natural killer cells that are known to be involve in repeated implantation failure and recurrent miscarriages.Intralipid is made of purified soybean oil, egg phospholipids, glycerol and water. It provides essential fatty acids, linoleic acid, omega- 3 and 6 fatty acids and alpha-linolenic acid. The effects of Intralipid in suppressing natural killer cell activity (NKa) were found to be comparable to intravenous immunoglobulin (IVIG) by laboratory experiments.We will study the effect of intralipid infusion on the pregnancy outcome of women aged 35-40 years with history of repeated implantation failure of miscarriage and who have positive peripheral blood natural killer cells

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Detailed Description

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Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intralipid infusion

100 Subfertile women aged 35-40 years with repeated implantation failure or recurrent miscarriage with positive natural killer cells undergoing ICSI cycle.

Group Type ACTIVE_COMPARATOR

Intralipid infusion

Intervention Type DRUG

IV infusion of 250 ml of intralipid 20% solution at the day of Ovum pick up \& another dose at the day of embryo Transfer.

Control group

100 Subfertile women aged 35-40 years with repeated implantation failure or recurrent miscarriage with positive natural killer cells undergoing ICSI cycle.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Intralipid infusion

IV infusion of 250 ml of intralipid 20% solution at the day of Ovum pick up \& another dose at the day of embryo Transfer.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Subfertile women aged 35-40 years with repeated implantation failure or recurrent miscarriage with positive natural killer cells undergoing Intracytoplasmic sperm injection (ICSI ) cycle.

Exclusion Criteria

* women above 40years or less than 35 years
* Disturbances of normal fat metabolism such as pathologic hyperlipidemia,Lipoid nephrosis or acute pancreatitis with hyperlipidemia.
* Allergic to eggs, soybean oil, or safflower oil.
* Severe liver disease, kidney disease, lung disease, anemia, blood coagulation disorder.
* Uterine fibroid, endometrial polyp, endometriosis and hydrosalpinx.
* Antiphospholipid syndrome (lupus anticoagulant and/or anticardiolipin antibodies (Immunoglobulin G or M)\[IgG or IgM\]); other recognised thrombophilic conditions (testing according to usual clinic practice).
* Intrauterine abnormalities (as assessed by ultrasound, hysterosonography, hysterosalpingogram, or hysteroscopy).
* Fibroids distorting uterine cavity.
* Abnormal parental karyotype.

Minimum Eligible Age

35 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes