Assessment of Intralipid Efficacy in Women With Unexplained Recurrent Implantation Failure

NCT ID: NCT02487940

Last Updated: 2016-12-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2015-04-30

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.

Detailed 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.

Conditions

Subfertility

Keywords

Recurrent implantation failure; IVF; ICSI; Intralipid

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Intralipid

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.

Group Type: ACTIVE_COMPARATOR

Intralipid 20%

Intervention Type: 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.

Placebo

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.

Group Type: PLACEBO_COMPARATOR

Normal saline

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

Lipofundin 20%; Solution of sodium chloride

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 38 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Dar El Teb Institute

OTHER

Sponsor Role: lead

Responsible Party

ISLAM GAMALELDIN

Specialist registrar Obstetrics and Gynaecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mostafa Gomaa, MD

Role: STUDY_DIRECTOR

Ain Shams univeristy hospitals

Other Identifiers

ASUH1234

Identifier Type: -

Identifier Source: org_study_id