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

NCT03374163 | Completed Phase 2 FDA Drug

• 1 other identifier: 15-442
• Study Type: interventional
• Target: 142
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Infertility Due to Nonimplantation

Keywords

infertility , implantion failure, intracytoplasmic sperm injection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• miscarrage rate

  miscarrage before 20 week gestation

• live birth rate

  delivery after 28 week gestation

Study Arms (2)

treatment group who recived intralipid

EXPERIMENTAL

71 patients who recived intralipid on day of embryo transfer day, pregnancy day.

Drug: intralipid 20%

control group

NO INTERVENTION

71 patient not recived intralipid

Interventions

intralipid 20% DRUG

milky soulation for energey supplement.

treatment group who recived intralipid

Eligibility Criteria

• Age: 21 Years - 42 Years
• Gender Eligibility Details: biologicaly female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• age \< 42 years
• BMI \< 30 kg/m2
• history of 3 or more recurrent implantation failure undergoing Intracytoplasmic Sperm Injection (ICSI ) cycle.

You may not qualify if:

• 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 .

Sponsors & Collaborators

• King Fahad Medical City: lead

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• solaiman s alobaid, MD

  King Fahad Medical City

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: fellow

Model Details: 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.

Study Record Dates

• First Submitted: December 5, 2017
• First Posted: December 15, 2017
• Study Start: January 1, 2015
• Primary Completion: June 30, 2017
• Study Completion: June 30, 2017
• Last Updated: December 15, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will share