Infertility
Conditions
Keywords
Infertility, intralipid, invitro fertilization, repeated implantation failure, repeated miscarriage
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
Interventions
IV infusion of 250 ml of intralipid 20% solution at the day of Ovum pick up & another dose at the day of embryo Transfer.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
35 Years to 40 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical pregnancy rate | 10 months | Intrauterine gestational sac with fatal pole and positive pulsation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
Egypt
Outcome results
None listed