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Assessment of Intralipid Efficacy in Women With Unexplained Recurrent Implantation Failure

NCT02487940 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2016-12-29

No results posted yet for this study

Summary

The study will include 100 women with unexplained recurrent implantation failure undergoing IVF/ICSI cycle.

Patients fulfilling the inclusion criteria will be randomised into two groups.

Study Group:

This group will include 50 women with unexplained recurrent implantation failure undergoing a trial of IVF/ICSI. This group will receive intravenous infusion of intralipid 20%, on the day of oocyte retrieval, a second dose on/ the following day of positive pregnancy test and a final dose 2-3 weeks later when attending for pregnancy scan.

Control Group:

This group will include 50 women with unexplained recurrent implantation failure undergoing a trial of IVF/ICSI. This group will receive intravenous infusion of placebo, on the day of oocyte retrieval, a second dose on/ the following day of positive pregnancy test and a final dose 2-3 weeks later when attending for pregnancy scan.

Conditions

  • Subfertility

Interventions

DRUG

Intralipid 20%

Women with RIF received intralipid 20% (at a dose of 9mg/mL of the total blood volume, corresponding to 2 mL intralipid diluted at 20% in 250 mL normal saline) given over 1-2 hours on the day of oocyte retrieval. Dose is repeated on/the following day of a positive pregnancy test, followed by a final dose 2-3 weeks later when attending for pregnancy scan.

DRUG

Normal saline

Women with RIF received intravenous infusion of 250 mL physiological saline solution over 1-2 hours on the day of oocyte retrieval. Dose is repeated on/the following day of a positive pregnancy test, followed by a final dose 2-3 weeks later when attending for pregnancy scan.

Sponsors & Collaborators

  • Dar El Teb Institute

    lead OTHER

Principal Investigators

  • Mostafa Gomaa, MD · Ain Shams univeristy hospitals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
38 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2015-04-30
Completion
2015-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02487940 on ClinicalTrials.gov