Status:

TERMINATED

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

Lead Sponsor:

Cairo University

Conditions:

Infertility

Eligibility:

FEMALE

35-40 years

Phase:

PHASE3

Brief Summary

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, gly...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

May 1 2013

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

February 1 2015

Estimated Enrollment :

200 Patients enrolled

Trial Details

Trial ID

NCT01916798

Start Date

May 1 2013

End Date

February 1 2015

Last Update

April 1 2020

Active Locations (1)

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1

Cairo University

Cairo, Egypt