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

Sponsor

Cairo University (Other)

Overall Status

Terminated

CT.gov ID

NCT01916798

Collaborator

(none)

200

Enrollment

Location

Arms

21.1

Actual Duration (Months)

9.5

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

Actual 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.

Actual Study Start Date :

May 1, 2013

Actual Primary Completion Date :

Jan 1, 2015

Actual Study Completion Date :

Feb 1, 2015

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Clinical pregnancy rate [10 months]
Intrauterine gestational sac with fatal pole and positive pulsation

Secondary Outcome Measures

Chemical pregnancy [10 months]
positive pregnancy test (serum BHCG) measured 16 days following embryo transfer
implantation rate [10 months]
the number of gestational sacs divided by the number of embryos transferred
ongoing pregnancy rate [10 months]
clinical pregnancy continue after 12 weeks gestational age
Miscarriage rate [12 months]
Ectopic rate [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.