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

Phase 2

Completed

• Conditions: Infertility Due to Nonimplantation
• Interventions: Drug: intralipid 20%

• Registration Number: NCT03374163
• Lead Sponsor: King Fahad Medical City

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2015-01-01
• Primary Completion: 2017-06-30
• Study Completion: 2017-06-30
• Status Verified: 2017-12
• Study First Submitted: 2017-12-05
• Study First Submitted QC: 2017-12-11
• Last Update Submitted: 2017-12-11
• Study First Posted: 2017-12-15
• Last Update Posted: 2017-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 142

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 .

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
treatment group who recived intralipid	intralipid 20%	71 patients who recived intralipid on day of embryo transfer day, pregnancy day.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
miscarrage rate	miscarrage before 20 week gestation	number of patient with miscarrage over study population number in study period
live birth rate	delivery after 28 week gestation	number of patient with delivery after 28 week gestation over study population number in study period.