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 Overview
=================
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.

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

Conditions
-----------------
Infertility Due to Nonimplantation

Intervention / Treatment
-----------------
* Drug: intralipid 20%


Participation Criteria
=================
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 .

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 42 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
infertility , implantion failure, intracytoplasmic sperm injection