Intralipid for Repeated Implantation Failure

Cairo University (CU)

Status and phase: Completed; Phase 3; Phase 2

Conditions: Infertility

Treatments: Drug: Saline; Drug: intralipid

Study type: Interventional

Funder types: Other

Identifiers

NCT01540591

22012

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups, including a placebo group

control

Placebo Comparator group

Description:

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

Treatment:

Drug: Saline

intralipid

Experimental group

Description:

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

Treatment:

Drug: intralipid