Assessment of Intralipid Efficacy in Women With Unexplained Recurrent Implantation Failure

NCT02487940 | Completed Phase 4 DMC

• 1 other identifier: ASUH1234
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study will include 100 women with unexplained recurrent implantation failure undergoing IVF/ICSI cycle. Patients fulfilling the inclusion criteria will be randomised into two groups. Study Group: This group will include 50 women with unexplained recurrent implantation failure undergoing a trial of IVF/ICSI. This group will receive intravenous infusion of intralipid 20%, on the day of oocyte retrieval, a second dose on/ the following day of positive pregnancy test and a final dose 2-3 weeks later when attending for pregnancy scan. Control Group: This group will include 50 women with unexplained recurrent implantation failure undergoing a trial of IVF/ICSI. This group will receive intravenous infusion of placebo, on the day of oocyte retrieval, a second dose on/ the following day of positive pregnancy test and a final dose 2-3 weeks later when attending for pregnancy scan.

Conditions

Subfertility

Keywords

Recurrent implantation failure; IVF; ICSI; Intralipid

Outcome Measures

Primary Outcomes (1)

• Live birth rates

  up to 40 weeks gestation

Secondary Outcomes (2)

• Clinical pregnancy rates

  6 weeks gestation (2 weeks following embryo transfer)

• side effects and tolerability of Intralipid

  up to 40 weeks gestation

Study Arms (2)

Intralipid

ACTIVE COMPARATOR

Women with RIF received intralipid 20% (at a dose of 9mg/mL of the total blood volume, corresponding to 2 mL intralipid diluted at 20% in 250 mL normal saline) given over 1-2 hours on the day of oocyte retrieval. Dose is repeated on/the following day of a positive pregnancy test, followed by a final dose 2-3 weeks later when attending for pregnancy scan.

Drug: Intralipid 20%

Placebo

PLACEBO COMPARATOR

Women with RIF received intravenous infusion of 250 mL physiological saline solution over 1-2 hours on the day of oocyte retrieval. Dose is repeated on/the following day of a positive pregnancy test, followed by a final dose 2-3 weeks later when attending for pregnancy scan.

Drug: Normal saline

Interventions

Intralipid 20% DRUG

Women with RIF received intralipid 20% (at a dose of 9mg/mL of the total blood volume, corresponding to 2 mL intralipid diluted at 20% in 250 mL normal saline) given over 1-2 hours on the day of oocyte retrieval. Dose is repeated on/the following day of a positive pregnancy test, followed by a final dose 2-3 weeks later when attending for pregnancy scan.

Also known as: Lipofundin 20%

Intralipid

Normal saline DRUG

Women with RIF received intravenous infusion of 250 mL physiological saline solution over 1-2 hours on the day of oocyte retrieval. Dose is repeated on/the following day of a positive pregnancy test, followed by a final dose 2-3 weeks later when attending for pregnancy scan.

Also known as: Solution of sodium chloride

Placebo

Eligibility Criteria

• Age: 20 Years - 38 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 20-38 years of age.
• Repeated implantation failure with 3 or more failed IVF cycles with good quality embryos.
• Normal trans-vaginal ultrasonography.
• Normal hysteroscopy.
• Normal male and female karyotyping.
• Normal anti cardiolipin antibody IGG, IGM and Lupus anticoagulant.
• Normal thrombophilia screen in the form of protein c, s, anti thrombin iii and factor v leiden.
• Written and signed informed consent by the patient to participate in the study.

You may not qualify if:

• Age more than 38 years.
• Less than 3 failed IVF cycles.
• Poor embryo quality.
• Expected poor ovarian response.
• Abnormal trans-vaginal ultrasound findings e.g. endometrial polyps or fibroids.
• Abnormal male or female karyotyping.
• Abnormal hysteroscopic finding e.g. endometrial polyps, endometrial hyperplasia, fibroid or congenital anomalies.
• Positive Anticardiolipin antibodies or Lupus anticoagulant.
• Positive thrombophilia screen.
• Allergy to soy oil, eggs, peanut, peanut-based products or any active ingredient in the infusion.
• Mental condition rendering the patients unable to understand the nature, scope and possible consequences of the study.

Sponsors & Collaborators

• Dar El Teb Institute: lead

MeSH Terms

Conditions

Infertility

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Mostafa Gomaa, MD

  Ain Shams univeristy hospitals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist registrar Obstetrics and Gynaecology

Study Record Dates

• First Submitted: June 30, 2015
• First Posted: July 2, 2015
• Study Start: October 1, 2012
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: December 29, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will share