Effects of Embryogen in RIF Patients

Vietnam National University

Status and phase: Completed; Phase 4

Conditions: Infertility

Treatments: Biological: GM-CSF

Study type: Interventional

Funder types: Other

Identifiers

NCT02250768

CGRH-Embryogen

Details and patient eligibility

About

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)

Full 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.

Enrollment: 60 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

GM-CSF

Experimental group

Description:

Injected oocytes were cultured in GM-CSF supplemented media until day of transfer

Treatment:

Biological: GM-CSF