EmbryoGen/ Blastgen for Couples With Implantation Problems or Previous Miscarriage

Phase 4

Completed

• Conditions: Recurrent Miscarriage; Infertility
• Interventions: Device: Standard Cook sequential media; Device: EmbryoGen/ BlastGen media

• Registration Number: NCT02305420
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2014-11
• Study First Submitted: 2014-11-27
• Study First Submitted QC: 2014-11-27
• Study First Posted: 2014-12-02
• Primary Completion: 2017-06
• Study Completion: 2017-06-14
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-14
• Last Update Posted: 2018-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Control	Standard Cook sequential media	Standard Cook sequential media
EmbryoGen/BlastGen	EmbryoGen/ BlastGen media	EmbryoGen and BlasGen media containing GM-CSF 2ng/ml will be used in the experimental arm The intervention is to use EmbryoGen/BlastGen

Primary Outcome Measures

Name	Time	Method
Livebirth >20 weeks	9 months after closure of trial (18 +9 months)	Any delivery \>20 resulting in a livebirth

Secondary Outcome Measures

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

Trial Locations

Locations (1)

FertilitySA; 🇦🇺 Adelaide, South Australia, Australia