NCT02250768

Effects of Embryogen in RIF Patients

Effects of Granulocyte - Macrophage Colony - Stimulating Factor (GM-CSF) Supplementation in Embryo Culture in Patients With Repeated Implantation Failure

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Vietnam National University · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study was to investigate the potential effects of Granulocyte-Macrophage Stimulating-Colony Factor (GM-CSF) supplementation in embryo culture for patients with repeated implantation failure (RIF)

Detailed description

60 patients with repeated implantation failure were involved. RIF was defined as patients failed to conceive (beta-hCG \< 5 mIU/mL) after at least 03 embryo transfers (fresh and frozen) with 06 top quality embryos or more. Ovarian stimulation was performed using GnRH antagonist protocol. All matured oocytes were inseminated by ICSI. Injected oocytes were cultured in medium supplemented with 2ng/ml of GM-CSF (Embryogen, Origio) until day of transfer. Embryo evaluation was performed at fixed time points of 18 and 44 hour after fertilization. Embryo transfer was performed 2 days after ovum retrieval. Luteal-phase support was provided using progesterone gel (Crinone 8% 90 mg, twice a day; Merck Serono) and estradiol per os (Valiera 2mg, twice a day; Laboratorios Recalcine). Serum hCG was measured 16 days after oocyte retrieval, and if positive, an ultrasound scan was performed at gestational weeks 7 and 12.

Conditions

• Infertility

Interventions

Type	Name	Description
BIOLOGICAL	GM-CSF	2ng/ml of GM-CSF supplemented into culture media

Timeline

• Start date: 2013-07-01
• Primary completion: 2014-03-01
• Completion: 2014-08-01
• First posted: 2014-09-26
• Last updated: 2014-09-26

Locations

2 sites across 1 country: Vietnam