Effect Of Intravenous IntralipidTherapyon Pregnancy Outcome in Women With History of Recurrent Implantation Failure Undergoing Intracytoplasmic Sperm Injection-Embryo Transfer Cycle: A Randomized Controlled Trial

King Fahad Medical City142 enrolled

Overview

To evaluate the effect ofempiricintralipidinfusion therapy on pregnancy outcomes in patient withunexplained recurrentimplantation failure (RIF) undergoIntracytoplasmic sperm injection (ICSI).

the aim to evaluate the effect ofempiricintralipidinfusion therapy on pregnancy outcomes in patient withunexplained recurrentimplantation failure (RIF) undergoIntracytoplasmic sperm injection (ICSI). A total of 142 patients with history of unexplained RIF3 or more cycles were included in the study. Patient were randomized into two groups, study group (n=71) and control group (n=71). The study groupreceivedintralipid 20%infusionon the day of embryo transfer (ET) and a second dose on the day of pregnancy test. The control group underwent ET without intralipidinfusion.Allpatientswereclosely monitored for any side effectsincluding allergic reactions.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

142

Conditions

Infertility Due to Nonimplantation

Interventions

intralipid 20%DRUG

milky soulation for energey supplement.

Eligibility

Sex: FEMALEMin age: 21 YearsMax age: 42 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * age \< 42 years * BMI \< 30 kg/m2 * history of 3 or more recurrent implantation failure undergoing Intracytoplasmic Sperm Injection (ICSI ) cycle. exclusion criteria * women with medical contraindications of intralipidinfusion. * uterine fibroid. * endometrial polyp. * endometriosis,hydrosalpinx. * intrauterine adhesion and uterine anomalies. * Women with positive thrombophilia screen. * diminished ovarian reserve. * severe male factor infertility . * chronic medical illnesses which may contribute in impaired chance of pregnancy .

Outcomes

Primary Outcomes

pregnancy rate

number of patient with positive b-hcg level 14 day post embryo transfer day.over the study population number in study period.

Time frame: 14 day post embryo transfer day

Secondary Outcomes

miscarrage rate

number of patient with miscarrage over study population number in study period

Time frame: miscarrage before 20 week gestation

live birth rate

number of patient with delivery after 28 week gestation over study population number in study period.

Time frame: delivery after 28 week gestation

Data from ClinicalTrials.gov

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