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Completed

NCT Number: NCT01540591

Intralipid for Repeated Implantation Failure

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

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Kasr Al-ainy hospital

Cairo, 12211, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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

Other names: intralipid 20%

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

Other names: Saline 0.9%

Primary outcomes

  1. clinical pregnancy rate

    Time frame: 10 month

    pregancy sac with fetal heart activity

Secondary outcomes

  1. implantation rate

    Time frame: 10 month

    the number of gestational sacs divided by the number of embryos transferred

  2. ongoing pregnancy rate

    Time frame: 14 month

    clinical pregnancy continue after 12 weeks gestational age

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Acronym: Intralipid

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Feb 29, 2012
Registry last updated
Sep 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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