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Intralipid infusion can improve outcome in women with recurrent Intracytoplasmic sperm injection ( ICSI) failure due to elevated TH1 cytokine response.
Infertile patients undergoing Intracytoplasmic Sperm Injection (ICSI) cycle with history of repeated implantation failure, intralipid will be given to the intervention group.
The primary outcome measure is the clinical pregnancy rate, secondary outcome measures implantation rate, ongoing pregnancy rate, abortion rate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control | Placebo Comparator | Saline 0.9% IV infusion between day 4 and 9 of ovarian stimulation & another dose when got pregnant within the 1st week of positive pregnancy test |
|
| intralipid | Experimental | IV infusion of intralipid 20% between day4 and 9 of ovarian stimulation & another dose when got pregnant within the 1st week of positive pregnancy test |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intralipid | Drug | IV infusion of intralipid 20% between day4 and 9 of ovarian stimulation & another dose when got pregnant within the 1st week of positive pregnancy test |
|
| Measure | Description | Time Frame |
|---|---|---|
| clinical pregnancy rate | pregancy sac with fetal heart activity | 10 month |
| Measure | Description | Time Frame |
|---|---|---|
| implantation rate | the number of gestational sacs divided by the number of embryos transferred | 10 month |
| ongoing pregnancy rate | clinical pregnancy continue after 12 weeks gestational age |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Waleed El-khayat, M.D. | Faculty of medicine, Cairo University, Cairo, Egypt | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kasr Al-ainy hospital | Cairo | 12211 | Egypt |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| C545823 | soybean oil, phospholipid emulsion |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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|
| Saline | Drug | Saline 0.9% IV infusion between day4 and 9 of ovarian stimulation & another dose when got pregnant within the 1st week of positive pregnancy test |
|
|
| 14 month |
| D017670 |
| Sodium Compounds |