Assessment of Intralipid Efficacy in Women With Unexplained Recurrent Implantation Failure
Condition: Subfertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      The study will include 100 women with unexplained recurrent implantation failure undergoing
      IVF/ICSI cycle.

      Randomisation:

      Patients fulfilling the inclusion criteria will randomised to 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.

      Random allocation sequence generation:

      A computer generated list will be used, assigning each participant number to either study
      groups.

      Allocation Concealment:

      Assignment will be done by sequentially numbered, otherwise identical, sealed envelopes
      (SNOSE), each containing a 2-inch by 2-inch paper with a written code designating the
      assigned group. These papers will be placed in a folded sheet of aluminium foil fitted inside
      the envelope. Effort will be taken to assure absence of any detectable differences in size or
      weight between intervention and control envelopes. Envelopes will be chosen to be opaque and
      lined inside with carbon paper. Envelopes will be opened sequentially only after writing the
      subject's tracking information on the envelope so that the carbon paper served as an audit
      trail.

      Blinding:

      Both drug with active ingredient and placebo will be provided by the hospital pharmacy in
      identical sealed opaque containers, equal in weight, similar in appearance, and tamper-proof.
      The drug with the active ingredient containers will be labeled either Group A or Group B by
      the head pharmacist and the assignment kept secret to be revealed after the end of the study.

      Drugs will be administered to patients by a sealed opaque infusion drip.

      IVF/ICSI cycle will be done using the standard LLP in both groups.

      Primary outcome will be Live birth rates.

      Secondary outcomes will be clinical pregnancy rates and side effects/tolerability of
      Intralipid infusion.
    

Intervention name(s): Intralipid 20%; Normal saline
Intervention type(s): Drug; Drug
Intervention description(s): 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.; 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.
Other intervention name(s): Lipofundin 20%; Solution of sodium chloride
Intervention MeSH terms: Soybean oil, phospholipid emulsion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Recurrent implantation failure; IVF; ICSI; Intralipid