Subfertility Clinical Trial
Official title:
Assessment of the Efficacy of Intralipid 20% in Management of Women With Unexplained Recurrent Implantation Failure in IVF Cycles: A Double Blinded Randomised Controlled Trial
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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