EmbryoGen/ Blastgen for Couples With Implantation Problems or Previous Miscarriage (BlastGen)

February 14, 2018 updated by: FertilitySA

EmbryoGen and BlastGen contain the cytokine growth factor Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF), which has been documented to give significant benefit to this difficult group of patients.

Results showed a highly significant effect of 44% relative improvement in ongoing implantation rate (p=0.001) in women who have previously miscarried (Ziebe et al 2013).

We wish to undertake a randomised Controlled trial to determine if EmbryoGen/BlastGen media improves pregnancy outcomes in women with recurrent implantation failure, recurrent miscarriage and poor embryo development when compared to standard media.

Study Overview

Detailed Description

A randomised control pilot study will be undertaken for 100 women who have implantation failure (≥ 2 embryo transfers without a pregnancy) or at least 1 previous miscarriage and are having a further IVF cycle.

At oocyte retrieval each couple will be randomised using numbered envelopes containing pre randomised group allocations by a person uninvolved in the trial to:

  1. BlastGen Group (n=50): culturing their embryos in ORIGIO standard, sequential culture mediums for 3 days (EmbryoGen included) then BlastGen media (GM-CSF containing media) for remaining 2 days or
  2. Standard Media Group (n=50): culturing their embryos in Cook standard sequential medium for 5 days.

The best single embryo will be transferred on day 5.

The clinical staff and participating couple will be blinded as to whether BlastGen or standard media was used in culture to day 5. Fertility SA embryologists will not be blind as to which study group a couple is in and which media is being used. The embryos will be cultured using the usual methods and lab facilities by Fertility SA's current embryology staff members who will not be blind to the media being used.

Records on the outcome of the oocyte fertilisation, blastocyst development, implantation rate and pregnancy rates will be recorded, as is standard practice. Pregnancy scans will be carried out at 7 and 12 weeks. Live birth outcomes and any congenital anomalies will be recorded.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • South Australia
      • Adelaide, South Australia, Australia, 5006
        • FertilitySA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 41 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • women undertaking an IVF or ICSI cycle

    • aged between 25 and 41 years
    • 2 or more embryos transferred without a positive pregnancy outcome OR a history of at least 1 previous pregnancy loss, OR
    • Poor embryo development (<20% of embryo developing on time at Day 3 or no blastocyst above Grade 2 on Day 5)

Exclusion Criteria:

  • male partner requiring surgical retrieval of sperm except in cases of previous vasectomy
  • the use of another investigational drug within 30 days
  • any severe chronic disease that would significantly influence an IVF cycle
  • less than 3 follicles>14mm on ultrasound on the day of HCG trigger

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EmbryoGen/BlastGen

EmbryoGen and BlasGen media containing GM-CSF 2ng/ml will be used in the experimental arm

The intervention is to use EmbryoGen/BlastGen

Embryos will be cultured in media containing Gm-CSF (EmbryoGen/ BlastGen media)
Other Names:
  • GM-CSF containing media
Active Comparator: Control
Standard Cook sequential media
Standard Cook IVF media will be used in the control arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Livebirth >20 weeks
Time Frame: 9 months after closure of trial (18 +9 months)
Any delivery >20 resulting in a livebirth
9 months after closure of trial (18 +9 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Congenital Anomaly Rate
Time Frame: 9 months after closure of trial (18 +9 months)
number of liveborns with a congenital anomaly
9 months after closure of trial (18 +9 months)
Clinical pregnancy rates at 7 and 12 weeks gestation
Time Frame: 18 months
Fetal Heart Beat seen on Ultrasound scan at 7 and 12 weeks
18 months
Number of embryos reaching blastocyst stage
Time Frame: 18 months
Number of blastocysts per cycle
18 months
Day 3 and day 5 embryo scores
Time Frame: 18 months
grade of day 3 and day 5 embryos
18 months
Cryopreservation outcomes
Time Frame: 18 months
Number of Frozen blastocysts
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Collaborators

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2014

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

June 14, 2017

Study Registration Dates

First Submitted

November 27, 2014

First Submitted That Met QC Criteria

November 27, 2014

First Posted (Estimate)

December 2, 2014

Study Record Updates

Last Update Posted (Actual)

February 19, 2018

Last Update Submitted That Met QC Criteria

February 14, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 8114

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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