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EmbryoGen/ Blastgen for Couples With Implantation Problems or Previous Miscarriage

NCT02305420 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2018-02-19

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

EmbryoGen/ BlastGen media

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

DEVICE

Standard Cook sequential media

Standard Cook IVF media will be used in the control arm

Sponsors & Collaborators

  • University of Adelaide

    collaborator OTHER

  • FertilitySA

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
25 Years
Max Age
41 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2017-06-30
Completion
2017-06-14

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02305420 on ClinicalTrials.gov