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Completed

NCT Number: NCT03374163

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

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

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Key information

Conditions

Infertility Due to Nonimplantation Genital Diseases Infertility Urogenital Diseases

Age range

21 year–42 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 .

Treatment and study plan

Intralipid 20%

Drug

milky soulation for energey supplement.

Primary outcomes

  1. 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.

Secondary outcomes

  1. miscarrage rate

    Time frame: miscarrage before 20 week gestation

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

  2. 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.

Sponsors and collaborators

Lead sponsor

King Fahad Medical City

Other Gov

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Dec 15, 2017
Registry last updated
Dec 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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