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

NCT ID: NCT03374163

Last Updated: 2017-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

142 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-01

Study Completion Date

2017-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Infertility Due to Nonimplantation

Keywords

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infertility , implantion failure, intracytoplasmic sperm injection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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treatment group who recived intralipid

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

Group Type EXPERIMENTAL

intralipid 20%

Intervention Type DRUG

milky soulation for energey supplement.

control group

71 patient not recived intralipid

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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intralipid 20%

milky soulation for energey supplement.

Intervention Type DRUG

Eligibility Criteria

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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 .
Minimum Eligible Age

21 Years

Maximum Eligible Age

42 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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King Fahad Medical City

OTHER_GOV

Sponsor Role lead

Responsible Party

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jawharah ali alzebidi

fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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solaiman s alobaid, MD

Role: PRINCIPAL_INVESTIGATOR

King Fahad Medical City

Other Identifiers

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15-442

Identifier Type: -

Identifier Source: org_study_id