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

Infertility Due to Nonimplantation Clinical 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03374163
• Other study ID #: 15-442
• Status: Completed
• Phase: Phase 2
• First received: December 5, 2017
• Last updated: December 11, 2017
• Start date: January 1, 2015
• Est. completion date: June 30, 2017

Study information

• Verified date: December 2017
• Source: King Fahad Medical City
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: June 30, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 42 Years

Eligibility

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 .

Related Conditions & MeSH terms

• Infertility
• Infertility Due to Nonimplantation

Intervention

Drug:
• intralipid 20%
milky soulation for energey supplement.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
King Fahad Medical City

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	miscarrage rate	number of patient with miscarrage over study population number in study period	miscarrage before 20 week gestation
Secondary	live birth rate	number of patient with delivery after 28 week gestation over study population number in study period.	delivery after 28 week gestation