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Intralipid for Repeated Implantation Failure

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Waleed El-khayat, Cairo University
ClinicalTrials.gov Identifier:
NCT01540591
First received: February 23, 2012
Last updated: July 14, 2014
Last verified: July 2014
  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:


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


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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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: July 14, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Cairo University:
repeated implantation failure
intralipid

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

ClinicalTrials.gov processed this record on November 25, 2014