Intralipid for Repeated Implantation Failure

Infertility Clinical Trial

— Intralipid  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01540591
• Other study ID #: 22012
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: February 23, 2012
• Last updated: September 14, 2016
• Start date: February 2012
• Est. completion date: June 2014

Study information

• Verified date: September 2016
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 2014
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• 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
• Saline
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

Locations

Country	Name	City	State
Egypt	Kasr Al-ainy hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical pregnancy rate	pregancy sac with fetal heart activity	10 month	No
Secondary	implantation rate	the number of gestational sacs divided by the number of embryos transferred	10 month	No
Secondary	ongoing pregnancy rate	clinical pregnancy continue after 12 weeks gestational age	14 month	No