Infertility Due to Nonimplantation
Conditions
Keywords
infertility , implantion failure, intracytoplasmic sperm injection
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.
Interventions
DRUGintralipid 20%
milky soulation for energey supplement.
Sponsors
King Fahad Medical City
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 42 Years
Healthy volunteers
Yes
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 .
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pregnancy rate | 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
| Measure | Time frame | Description |
|---|---|---|
| miscarrage rate | miscarrage before 20 week gestation | number of patient with miscarrage over study population number in study period |
| live birth rate | delivery after 28 week gestation | number of patient with delivery after 28 week gestation over study population number in study period. |
Outcome results
None listed