Assessment of Intralipid Efficacy in Women With Unexplained Recurrent Implantation Failure

Subfertility Clinical Trial

Official title:

Assessment of the Efficacy of Intralipid 20% in Management of Women With Unexplained Recurrent Implantation Failure in IVF Cycles: A Double Blinded Randomised Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02487940
• Other study ID #: ASUH1234
• Status: Completed
• Phase: Phase 4
• First received: June 30, 2015
• Last updated: December 28, 2016
• Start date: October 2012
• Est. completion date: April 2015

Study information

• Verified date: December 2016
• Source: Dar El Teb Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial 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.

Description:

The study will include 100 women with unexplained recurrent implantation failure undergoing IVF/ICSI cycle.

Randomisation:

Patients fulfilling the inclusion criteria will randomised to 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.

Random allocation sequence generation:

A computer generated list will be used, assigning each participant number to either study groups.

Allocation Concealment:

Assignment will be done by sequentially numbered, otherwise identical, sealed envelopes (SNOSE), each containing a 2-inch by 2-inch paper with a written code designating the assigned group. These papers will be placed in a folded sheet of aluminium foil fitted inside the envelope. Effort will be taken to assure absence of any detectable differences in size or weight between intervention and control envelopes. Envelopes will be chosen to be opaque and lined inside with carbon paper. Envelopes will be opened sequentially only after writing the subject's tracking information on the envelope so that the carbon paper served as an audit trail.

Blinding:

Both drug with active ingredient and placebo will be provided by the hospital pharmacy in identical sealed opaque containers, equal in weight, similar in appearance, and tamper-proof. The drug with the active ingredient containers will be labeled either Group A or Group B by the head pharmacist and the assignment kept secret to be revealed after the end of the study.

Drugs will be administered to patients by a sealed opaque infusion drip.

IVF/ICSI cycle will be done using the standard LLP in both groups.

Primary outcome will be Live birth rates.

Secondary outcomes will be clinical pregnancy rates and side effects/tolerability of Intralipid infusion.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 38 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility
• Subfertility

Intervention

Drug:
• Intralipid 20%
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.
• Normal saline
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Dar El Teb Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Live birth rates		up to 40 weeks gestation	Yes
Secondary	Clinical pregnancy rates		6 weeks gestation (2 weeks following embryo transfer)	Yes
Secondary	side effects and tolerability of Intralipid		up to 40 weeks gestation	Yes