NCT02305420

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2014

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

November 27, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 2, 2014

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 14, 2017

Completed
Last Updated

February 19, 2018

Status Verified

February 1, 2018

Enrollment Period

2.6 years

First QC Date

November 27, 2014

Last Update Submit

February 14, 2018

Conditions

Recurrent MiscarriageInfertility

Outcome Measures

Primary Outcomes (1)

  • Livebirth >20 weeks

    Any delivery \>20 resulting in a livebirth

    9 months after closure of trial (18 +9 months)

Secondary Outcomes (5)

  • Congenital Anomaly Rate

    9 months after closure of trial (18 +9 months)

  • Clinical pregnancy rates at 7 and 12 weeks gestation

    18 months

  • Number of embryos reaching blastocyst stage

    18 months

  • Day 3 and day 5 embryo scores

    18 months

  • Cryopreservation outcomes

    18 months

Study Arms (2)

EmbryoGen/BlastGen

EXPERIMENTAL

EmbryoGen and BlasGen media containing GM-CSF 2ng/ml will be used in the experimental arm The intervention is to use EmbryoGen/BlastGen

Device: EmbryoGen/ BlastGen media

Control

ACTIVE COMPARATOR

Standard Cook sequential media

Device: Standard Cook sequential media

Interventions

EmbryoGen/ BlastGen mediaDEVICE

Embryos will be cultured in media containing Gm-CSF (EmbryoGen/ BlastGen media)

Also known as: GM-CSF containing media
EmbryoGen/BlastGen
Standard Cook sequential mediaDEVICE

Standard Cook IVF media will be used in the control arm

Control

Eligibility Criteria

Age25 Years - 41 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • women undertaking an IVF or ICSI cycle
  • aged between 25 and 41 years
  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

FertilitySA

Adelaide, South Australia, 5006, Australia

Location

Related Publications (1)

  • Rose RD, Barry MF, Dunstan EV, Yuen SM, Cameron LP, Knight EJ, Norman RJ, Hull ML. The BlastGen study: a randomized controlled trial of blastocyst media supplemented with granulocyte-macrophage colony-stimulating factor. Reprod Biomed Online. 2020 May;40(5):645-652. doi: 10.1016/j.rbmo.2020.01.011. Epub 2020 Jan 23.

    PMID: 32220517DERIVED

MeSH Terms

Conditions

Abortion, HabitualInfertility

Condition Hierarchy (Ancestors)

Abortion, SpontaneousPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Randomised control trial comparing EmbryoGen/ BlastGen media use with standard media in IVF
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2014

First Posted

December 2, 2014

Study Start

November 1, 2014

Primary Completion

June 1, 2017

Study Completion

June 14, 2017

Last Updated

February 19, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)