Abortion, Habitual, Abortion, Spontaneous
Conditions
Keywords
Recurrent miscarriage, Implantation failure, Intralipid, ICSI / IVF failure
Brief summary
Intralipid infusion can improve the outcome in NK cells positive females with history of recurrent miscarriages undergoing IVF/ICSI cycles.
Interventions
DRUGIntralipid
IV infusion of intralipid 20% is administrated on the day of vaginal egg collection in a dose of 9 mg/ml total blood volume corresponding to intralipid 2 ml 20% diluted in 250 ml saline over 30-60 minutes.the intralipid infusion is then repeated within the 1st week of positive pregnancy test and every 2 weeks till end of first trimester
Sponsors
Woman's Health University Hospital, Egypt
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Couples with unexplained secondary infertility * Three or more prior consecutive clinical miscarriages after either spontaneous pregnancy or after IVF/ICSI. * Elevated natural killer (NK) cells CD16, CD56 and cells with both CD16/CD56 \>12%.
Exclusion criteria
* Age above forty years old. * Antiphospholipid syndrome (lupus anticoagulant and/or anticardiolipin antibodies \[IgG or IgM\]); other recognised thrombophilic conditions (testing according to usual clinic practice). * Intrauterine abnormalities (as assessed by ultrasound, hysterosonography, hysterosalpingogram, or hysteroscopy). * Abnormal parental karyotype. * Other identifiable causes of recurrent miscarriages (tests initiated only if clinically indicated) e.g., diabetes, thyroid disease and systemic lupus erythematosus (SLE). * Disturbances of normal fat metabolism such as pathologic hyperlipemia * Allergic to it; or to eggs, soybean oil, or safflower oil. * Severe liver disease, kidney disease, lung disease, anemia, blood clotting disorder.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| chemical pregnancy rate | 10 months | Positive pregnancy test in blood as measured by quantitative B- hCG level |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| clinical pregnancy rate, | 10 months | Confirmed pregnancy at 7 weeks by ultrasound visualization of gestational sac and positive fetal pulsations |
Other
| Measure | Time frame | Description |
|---|---|---|
| ongoing pregnancy rate | 10 months | clinical pregnancy continue after 12 weeks gestational age |
| abortion rate | 12 months | — |
Countries
Egypt
Outcome results
None listed