Clinical trial 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Infertility Due to Nonimplantation
Keywords: infertility , implantion failure, intracytoplasmic sperm injection
Lead sponsor: King Fahad Medical City
Sponsor class: OTHER_GOV
First posted: 2017-12-15
Enrollment: 142
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.

Eligibility 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 .

Primary outcomes:
measure: pregnancy rate
timeFrame: 14 day post embryo transfer day
Secondary outcomes:
measure: miscarrage rate
timeFrame: miscarrage before 20 week gestation
measure: live birth rate
timeFrame: delivery after 28 week gestation
Other outcomes:
Locations:
Study officials:
affiliation: King Fahad Medical City
name: solaiman s alobaid, MD
role: PRINCIPAL_INVESTIGATOR
References: