Subfertility Clinical Trial
Official title:
Effect of Intralipid Infusion in Patients With Recurrent Implantation Failure (A Randomized Controlled Trial)
The aim of present study is to evaluate the effect of intralipid 20% infusion, once between days 4 and 9 of the ovarian stimulation, and again within 7 days of a positive pregnancy test on clinical pregnancy rates in women with unexplained recurrent implantation failure.
The study will include 300 women with unexplained recurrent implantation failure undergoing
IVF/ICSI cycle.
Randomization:
Patients fulfilling the inclusion criteria will be randomized to two groups.
Study Group:
This group will include 160 women with unexplained recurrent implantation failure undergoing
a trial of IVF/ICSI. This group will receive intravenous infusion of intralipid 20%, once
between days 4 and 9 of the ovarian stimulation, and again within 7 days of a positive
pregnancy test.
Control Group:
This group will include 160 women with unexplained recurrent implantation failure undergoing
a trial of IVF/ICSI. This group will receive intravenous infusion of placebo, once between
days 4 and 9 of the ovarian stimulation, and again within 7 days of a positive pregnancy
test.
Random allocation sequence generation:
A computer generated list via MedCalc ® Software, version 13.2.2 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 aluminum 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.
An endometrial biopsy (Wallach endocell sampler ® ) will be taken during the luteal phase of
the menstrual cycle and put in formalin. The biopsy will be embedded in paraffin, cut into
sections and immunohistochemistry will be used to identify uNK cells using an antibody to
CD56 and CD16 (NCL-CD56-16; Novacastra ® ). A cut-off of normality of 5% uNK cell density
will be used.
IVF/ICSI cycle will be done using the standard LLP in both groups.
primary outcome will be Live birth rate.
secondary outcomes will be biochemical and clinical pregnancy rates.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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