Abortion, Spontaneous Clinical Trial
Official title:
The Role of Intralipid in Natural Killer Cell Positive Cases With Recurrent Miscarriages Undergoing IVF/ICSI Cycles: a Double Blind Randomized Controlled Trial
Verified date | January 2018 |
Source | Woman's Health University Hospital, Egypt |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Intralipid infusion can improve the outcome in NK cells positive females with history of recurrent miscarriages undergoing IVF/ICSI cycles.
Status | Completed |
Enrollment | 300 |
Est. completion date | September 2016 |
Est. primary completion date | August 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Egypt | Kasr el ainy hospital | Cairo |
Lead Sponsor | Collaborator |
---|---|
Woman's Health University Hospital, Egypt |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | ongoing pregnancy rate | clinical pregnancy continue after 12 weeks gestational age | 10 months | |
Other | abortion rate | 12 months | ||
Primary | chemical pregnancy rate | Positive pregnancy test in blood as measured by quantitative B- hCG level | 10 months | |
Secondary | clinical pregnancy rate, | Confirmed pregnancy at 7 weeks by ultrasound visualization of gestational sac and positive fetal pulsations | 10 months |
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