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Intralipid for Repeated Implantation Failure (Intralipid)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01540591
First Posted: February 29, 2012
Last Update Posted: September 16, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Waleed El-khayat, Cairo University
  Purpose
Intralipid infusion can improve outcome in women with recurrent Intracytoplasmic sperm injection ( ICSI) failure due to elevated TH1 cytokine response.

Condition Intervention Phase
Infertility Drug: intralipid Drug: Saline Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Does Intralipid Infusion Improve the Implantation Rate in Repeated Implantation Failure: a Randomized Controlled Trial

Further study details as provided by Waleed El-khayat, Cairo University:

Primary Outcome Measures:
  • clinical pregnancy rate [ Time Frame: 10 month ]
    pregancy sac with fetal heart activity


Secondary Outcome Measures:
  • implantation rate [ Time Frame: 10 month ]
    the number of gestational sacs divided by the number of embryos transferred

  • ongoing pregnancy rate [ Time Frame: 14 month ]
    clinical pregnancy continue after 12 weeks gestational age


Enrollment: 200
Study Start Date: February 2012
Study Completion Date: June 2014
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: control
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
Drug: 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
Other Name: Saline 0.9%
Experimental: 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
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
Other Name: intralipid 20%

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01540591


Locations
Egypt
Kasr Al-ainy hospital
Cairo, Egypt, 12211
Sponsors and Collaborators
Cairo University
Investigators
Principal Investigator: Waleed El-khayat, M.D. Faculty of medicine, Cairo University, Cairo, Egypt
  More Information

Responsible Party: Waleed El-khayat, Assisstant professor, Cairo University
ClinicalTrials.gov Identifier: NCT01540591     History of Changes
Other Study ID Numbers: 22012
First Submitted: February 23, 2012
First Posted: February 29, 2012
Last Update Posted: September 16, 2016
Last Verified: September 2016

Keywords provided by Waleed El-khayat, Cairo University:
repeated implantation failure
intralipid

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Soybean oil, phospholipid emulsion
Fat Emulsions, Intravenous
Parenteral Nutrition Solutions
Pharmaceutical Solutions


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