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Trial record 70 of 179 for:    Phospholipids

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

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ClinicalTrials.gov Identifier: NCT01916798
Recruitment Status : Unknown
Verified December 2014 by Eman Elkattan, Cairo University.
Recruitment status was:  Recruiting
First Posted : August 6, 2013
Last Update Posted : December 30, 2014
Sponsor:
Information provided by (Responsible Party):
Eman Elkattan, Cairo University

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, 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

Condition or disease Intervention/treatment Phase
Infertility Drug: Intralipid infusion Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intravenous Intralipid Therapy Among Women Aged 35-40 Years With Positive Peripheral Blood Natural Killer Cells Undergoing in Vitro Fertilization-Embryo Transfer: A Randomized Controlled Trial.
Study Start Date : May 2013
Estimated Primary Completion Date : January 2015
Estimated Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

Arm Intervention/treatment
Active Comparator: Intralipid infusion
100 Subfertile women aged 35-40 years with repeated implantation failure or recurrent miscarriage with positive natural killer cells undergoing ICSI cycle.
Drug: 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.

No Intervention: Control group
100 Subfertile women aged 35-40 years with repeated implantation failure or recurrent miscarriage with positive natural killer cells undergoing ICSI cycle.



Primary Outcome Measures :
  1. Clinical pregnancy rate [ Time Frame: 10 months ]
    Intrauterine gestational sac with fatal pole and positive pulsation


Secondary Outcome Measures :
  1. Chemical pregnancy [ Time Frame: 10 months ]
    positive pregnancy test (serum BHCG) measured 16 days following embryo transfer

  2. implantation rate [ Time Frame: 10 months ]
    the number of gestational sacs divided by the number of embryos transferred

  3. ongoing pregnancy rate [ Time Frame: 10 months ]
    clinical pregnancy continue after 12 weeks gestational age

  4. Miscarriage rate [ Time Frame: 12 months ]
  5. Ectopic rate [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01916798


Contacts
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Contact: Eman Elkattan, M.D,MRCOG 00201222854159 emyelkattan@gmail.com

Locations
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Egypt
Cairo University Recruiting
Cairo, Egypt
Contact: Eman Elkattan, M.D,M.R.C.O.G    00201222854159    emyelkattan@gmail.com   
Sponsors and Collaborators
Cairo University

Publications:
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Responsible Party: Eman Elkattan, Dr., Cairo University
ClinicalTrials.gov Identifier: NCT01916798     History of Changes
Other Study ID Numbers: Protocol 300
First Posted: August 6, 2013    Key Record Dates
Last Update Posted: December 30, 2014
Last Verified: December 2014

Keywords provided by Eman Elkattan, Cairo University:
Infertility
intralipid
invitro fertilization
repeated implantation failure
repeated miscarriage

Additional relevant MeSH terms:
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Infertility
Genital Diseases, Male
Genital Diseases, Female
Soybean oil, phospholipid emulsion
Fat Emulsions, Intravenous
Parenteral Nutrition Solutions
Pharmaceutical Solutions