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Intralipid for Repeated Implantation Failure

Does Intralipid Infusion Improve the Implantation Rate in Repeated Implantation Failure: a Randomized Controlled Trial

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01540591
Acronym
Intralipid
Enrollment
200
Registered
2012-02-29
Start date
2012-02-29
Completion date
2014-06-30
Last updated
2016-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

Keywords

repeated implantation failure, intralipid

Brief summary

Intralipid infusion can improve outcome in women with recurrent Intracytoplasmic sperm injection ( ICSI) failure due to elevated TH1 cytokine response.

Detailed description

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.

Interventions

DRUGintralipid

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

DRUGSaline

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

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

* Infertile patients undergoing ICSI cycle with history of repeated implantation failure

Exclusion criteria

1. Disturbances of normal fat metabolism such as pathologic hyperlipemia 2. Allergic to it; or to eggs, soybean oil, or safflower oil. 3. Severe liver disease, kidney disease, lung disease, anemia, blood clotting disorder. 4. Uterine fibroid, endometrial polyp, endometriosis and hydrosalpinx.

Design outcomes

Primary

MeasureTime frameDescription
clinical pregnancy rate10 monthpregancy sac with fetal heart activity

Secondary

MeasureTime frameDescription
implantation rate10 monththe number of gestational sacs divided by the number of embryos transferred
ongoing pregnancy rate14 monthclinical pregnancy continue after 12 weeks gestational age

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026