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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02250768

Acronym

RIF

Enrollment

Registered

2014-09-26

Start date

2013-07-31

Completion date

2014-08-31

Last updated

2014-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

Keywords

GM-CSF, repeated implantation failure

Brief 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.

Interventions

BIOLOGICALGM-CSF

2ng/ml of GM-CSF supplemented into culture media

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

Healthy volunteers

Yes

Inclusion criteria

* Normal ovarian reserve (AMH \> 1.1 ng/ml) * Regular menstrual cycle (25 - 34 days) * Clear informations about at least 3 latest IVF/ET * Fresh embryo transfer in this cycle * Endometrial thickness of 10 mm or more

Exclusion criteria

* Undergo oocyte donation or in vitro maturation (IVM) cycles * Using frozen or surgically retrieved sperm * Adenomyosis, Uterine anomaly, uterine fibroid, hydrosalpinges * In participation in other studies/interventions

Design outcomes

Primary

Measure	Time frame
ongoing pregnancy rate	12 week of gestation

Secondary

Measure	Time frame
Implantation rate	7 week of gestation
clinical pregnancy rate	7 week of gestation
top quality embryo rate	44 hours after insemination

Countries

Vietnam

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026