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

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ClinicalTrials.gov Identifier: NCT02305420
Recruitment Status : Completed
First Posted : December 2, 2014
Last Update Posted : February 16, 2018
Sponsor:
Collaborator:
University of Adelaide
Information provided by (Responsible Party):
FertilitySA

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.


Condition or disease Intervention/treatment Phase
Recurrent Miscarriage Infertility Device: EmbryoGen/ BlastGen media Device: Standard Cook sequential media Phase 4

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  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Randomised control trial comparing EmbryoGen/ BlastGen media use with standard media in IVF
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: EmbryoGen/ Blastgen for Couples With Implantation Problems or Previous Miscarriage
Actual Study Start Date : November 2014
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 14, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Miscarriage

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

Device: EmbryoGen/ BlastGen media
Embryos will be cultured in media containing Gm-CSF (EmbryoGen/ BlastGen media)
Other Name: GM-CSF containing media

Active Comparator: Control
Standard Cook sequential media
Device: Standard Cook sequential media
Standard Cook IVF media will be used in the control arm




Primary Outcome Measures :
  1. Livebirth >20 weeks [ Time Frame: 9 months after closure of trial (18 +9 months) ]
    Any delivery >20 resulting in a livebirth


Secondary Outcome Measures :
  1. Congenital Anomaly Rate [ Time Frame: 9 months after closure of trial (18 +9 months) ]
    number of liveborns with a congenital anomaly

  2. 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

  3. Number of embryos reaching blastocyst stage [ Time Frame: 18 months ]
    Number of blastocysts per cycle

  4. Day 3 and day 5 embryo scores [ Time Frame: 18 months ]
    grade of day 3 and day 5 embryos

  5. Cryopreservation outcomes [ Time Frame: 18 months ]
    Number of Frozen blastocysts



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Ages Eligible for Study:   25 Years to 41 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02305420


Locations
Australia, South Australia
FertilitySA
Adelaide, South Australia, Australia, 5006
Sponsors and Collaborators
FertilitySA
University of Adelaide

Responsible Party: FertilitySA
ClinicalTrials.gov Identifier: NCT02305420     History of Changes
Other Study ID Numbers: 8114
First Posted: December 2, 2014    Key Record Dates
Last Update Posted: February 16, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Infertility
Abortion, Spontaneous
Abortion, Habitual
Genital Diseases, Male
Genital Diseases, Female
Pregnancy Complications