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 City

Status and phase: Completed; Phase 2

Conditions: Infertility Due to Nonimplantation

Treatments: Drug: intralipid 20%

Study type: Interventional

Funder types: Other

Identifiers

NCT03374163

15-442

Details and patient eligibility

About

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

Full description

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.

Enrollment: 142 patients

Sex: Female

Ages: 21 to 42 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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 .

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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142 participants in 2 patient groups

treatment group who recived intralipid

Experimental group

Description:

71 patients who recived intralipid on day of embryo transfer day, pregnancy day.

Treatment:

Drug: intralipid 20%

control group

No Intervention group

Description:

71 patient not recived intralipid