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Not able to recruit the number required and due to financial difficulty to pay for intralipids
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intralipid infusion | Active Comparator | 100 Subfertile women aged 35-40 years with repeated implantation failure or recurrent miscarriage with positive natural killer cells undergoing ICSI cycle. |
|
| Control group | No Intervention | 100 Subfertile women aged 35-40 years with repeated implantation failure or recurrent miscarriage with positive natural killer cells undergoing ICSI cycle. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intralipid infusion | Drug | IV infusion of 250 ml of intralipid 20% solution at the day of Ovum pick up & another dose at the day of embryo Transfer. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical pregnancy rate | Intrauterine gestational sac with fatal pole and positive pulsation | 10 months |
| Measure | Description | Time Frame |
|---|---|---|
| Chemical pregnancy | positive pregnancy test (serum BHCG) measured 16 days following embryo transfer | 10 months |
| implantation rate | the number of gestational sacs divided by the number of embryos transferred |
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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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo University | Cairo | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22340745 | Background | Coulam CB, Acacio B. Does immunotherapy for treatment of reproductive failure enhance live births? Am J Reprod Immunol. 2012 Apr;67(4):296-304. doi: 10.1111/j.1600-0897.2012.01111.x. Epub 2012 Feb 16. | |
| 22196107 | Background | Shreeve N, Sadek K. Intralipid therapy for recurrent implantation failure: new hope or false dawn? J Reprod Immunol. 2012 Jan;93(1):38-40. doi: 10.1016/j.jri.2011.11.003. Epub 2011 Dec 21. |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| 10 months |
| ongoing pregnancy rate | clinical pregnancy continue after 12 weeks gestational age | 10 months |
| Miscarriage rate | 12 months |
| Ectopic rate | 12 months |