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

December 11, 2017 updated by: jawharah ali alzebidi, King Fahad Medical City
To evaluate the effect ofempiricintralipidinfusion therapy on pregnancy outcomes in patient withunexplained recurrentimplantation failure (RIF) undergoIntracytoplasmic sperm injection (ICSI).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

142

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 42 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 .

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: treatment group who recived intralipid
71 patients who recived intralipid on day of embryo transfer day, pregnancy day.
Drug: intralipid 20%
milky soulation for energey supplement.
No Intervention: control group
71 patient not recived intralipid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pregnancy rate
Time Frame: 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.
14 day post embryo transfer day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
miscarrage rate
Time Frame: miscarrage before 20 week gestation
number of patient with miscarrage over study population number in study period
miscarrage before 20 week gestation
live birth rate
Time Frame: delivery after 28 week gestation
number of patient with delivery after 28 week gestation over study population number in study period.
delivery after 28 week gestation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Fahad Medical City

Investigators

  • Principal Investigator: solaiman s alobaid, MD, King Fahad Medical City

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

June 30, 2017

Study Completion (Actual)

June 30, 2017

Study Registration Dates

First Submitted

December 5, 2017

First Submitted That Met QC Criteria

December 11, 2017

First Posted (Actual)

December 15, 2017

Study Record Updates

Last Update Posted (Actual)

December 15, 2017

Last Update Submitted That Met QC Criteria

December 11, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-442

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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