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Intralipid for Repeated Implantation Failure

This study is currently recruiting participants.
Verified February 2012 by Cairo University
Sponsor:
Information provided by (Responsible Party):
Waleed El-khayat, Cairo University
ClinicalTrials.gov Identifier:
NCT01540591
First received: February 23, 2012
Last updated: February 28, 2012
Last verified: February 2012
History of Changes
  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
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Does Intralipid Infusion Improve the Implantation Rate in Repeated Implantation Failure: a Randomized Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Infertility
U.S. FDA Resources

Further study details as provided by Cairo University:

Primary Outcome Measures:
  • clinical pregnancy rate [ Time Frame: 10 month ] [ Designated as safety issue: No ]
    pregancy sac with fetal heart activity


Secondary Outcome Measures:
  • implantation rate [ Time Frame: 10 month ] [ Designated as safety issue: No ]
    the number of gestational sacs divided by the number of embryos transferred

  • ongoing pregnancy rate [ Time Frame: 14 month ] [ Designated as safety issue: No ]
    clinical pregnancy continue after 12 weeks gestational age


Estimated Enrollment: 200
Study Start Date: February 2012
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: control
no intervention
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

Ages Eligible for Study:   20 Years to 40 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01540591

Contacts
Contact: Waleed El-Khayat, M.D. 0100513542 ext +2 waleed_elkhyat@yahoo.com

Locations
Egypt
Kasr Al-ainy hospital Recruiting
Cairo, Egypt, 12211
Contact: Waleed El-khayat, M.D.     01005135542 ext +2     waleed_elkhyat@yahoo.com    
Principal Investigator: Waleed El-Khayat, M.D>            
Sponsors and Collaborators
Cairo University
Investigators
Principal Investigator: Waleed El-khayat, M.D. Faculty of medicine, Cairo University, Cairo, Egypt
  More Information

No publications provided

Responsible Party: Waleed El-khayat, Assisstant professor, Cairo University
ClinicalTrials.gov Identifier: NCT01540591     History of Changes
Other Study ID Numbers: 22012
Study First Received: February 23, 2012
Last Updated: February 28, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Cairo University:
repeated implantation failure
intralipid

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on June 18, 2013