Intralipid for Repeated Implantation Failure

Phase 2

Completed

• Conditions: Infertility
• Interventions: Drug: Saline; Drug: intralipid

• Registration Number: NCT01540591
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-02-23
• Study First Submitted QC: 2012-02-28
• Study First Posted: 2012-02-29
• Primary Completion: 2013-09
• Study Completion: 2014-06
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-14
• Last Update Posted: 2016-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control	Saline	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	intralipid	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

Primary Outcome Measures

Name	Time	Method
clinical pregnancy rate	10 month	pregancy sac with fetal heart activity

Secondary Outcome Measures

Name	Time	Method
implantation rate	10 month	the number of gestational sacs divided by the number of embryos transferred
ongoing pregnancy rate	14 month	clinical pregnancy continue after 12 weeks gestational age

Trial Locations

Locations (1)

Kasr Al-ainy hospital; 🇪🇬 Cairo, Egypt