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Study aim
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Investigating intravenous(IV) intralipid administration in people with recurrent implantation failure(RIF) during IVF/ICSI cycles.
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Design
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Clinical trial with a control group, with parallel groups, single-blind, randomized, phase 3 on 70 patients. The rand function of Excel software was used for randomization.
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Settings and conduct
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70 infertile patients with a history of frequent unexplained implantation failure referred to the infertility department of Taleghani Hospital of Tehran who were candidates for frozen embryos were randomly divided into two interventions.
control groups and the intervention group received intralipid on the first day of progesterone, positive pregnancy test, and 5 weeks after embryo transfer.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: embryos in ≤35 years and or at least 4 Day-3 embryos≥ 35 years old with Idiopathic RIF and: normal hormonal profile of FSH, LH , TSH, PRL, and AMH; normal uterine cavity by hysteroscopy; body mass index 20–32 kg/m2; normal oocytes and embryos(grade A;B).
Exclusion criteria:
Women with recurrent miscarriages; with obvious reasons for IVF failure such as fibroids or polyps as assessed by hysteroscopy, age over 40 years, women undergoing donor egg IVF, low-quality embryos, severe endometriosis; contraindications for coagulation disorders, high cholesterol, liver disease, sickle cell disease; allergic to egg, lecithin or soy products.
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Intervention groups
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The intervention group receiving IV intralipid in patients with a history of RIF who are candidates for frozen embryo transfer(FET) and investigating pregnancy outcomes.
The control group without receiving intralipid in patients with a history of RIF who are candidates for FET and investigation of pregnancy outcomes in them.
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Main outcome variables
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Implantation rate, Biochemical pregnancy rate, Clinical pregnancy rate, Ongoing pregnancy rate.