EmbryoGen/ Blastgen for Couples With Implantation Problems or Previous Miscarriage

Infertility Clinical Trial

— BlastGen  

Official title:

EmbryoGen/ Blastgen for Couples With Implantation Problems or Previous Miscarriage

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02305420
• Other study ID #: 8114
• Status: Completed
• Phase: Phase 4
• First received: November 27, 2014
• Last updated: February 14, 2018
• Start date: November 2014
• Est. completion date: June 14, 2017

Study information

• Verified date: February 2018
• Source: FertilitySA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 14, 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 41 Years

Eligibility

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

Related Conditions & MeSH terms

• Abortion, Habitual
• Abortion, Spontaneous
• Infertility
• Recurrent Miscarriage

Intervention

Device:
• EmbryoGen/ BlastGen media
Embryos will be cultured in media containing Gm-CSF (EmbryoGen/ BlastGen media)
• Standard Cook sequential media
Standard Cook IVF media will be used in the control arm

Locations

Country	Name	City	State
Australia	FertilitySA	Adelaide	South Australia

Sponsors (2)

Lead Sponsor	Collaborator
FertilitySA	University of Adelaide

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Livebirth >20 weeks	Any delivery >20 resulting in a livebirth	9 months after closure of trial (18 +9 months)
Secondary	Congenital Anomaly Rate	number of liveborns with a congenital anomaly	9 months after closure of trial (18 +9 months)
Secondary	Clinical pregnancy rates at 7 and 12 weeks gestation	Fetal Heart Beat seen on Ultrasound scan at 7 and 12 weeks	18 months
Secondary	Number of embryos reaching blastocyst stage	Number of blastocysts per cycle	18 months
Secondary	Day 3 and day 5 embryo scores	grade of day 3 and day 5 embryos	18 months
Secondary	Cryopreservation outcomes	Number of Frozen blastocysts	18 months