Effects of Embryogen in RIF Patients

Phase 4

Completed

• Conditions: Infertility
• Interventions: Biological: GM-CSF

• Registration Number: NCT02250768
• Lead Sponsor: Vietnam National University

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.

Study Timeline

• Study Start: 2013-07
• Primary Completion: 2014-03
• Study Completion: 2014-08
• Status Verified: 2014-09
• Study First Submitted: 2014-09-23
• Study First Submitted QC: 2014-09-23
• Last Update Submitted: 2014-09-23
• Study First Posted: 2014-09-26
• Last Update Posted: 2014-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
ongoing pregnancy rate	12 week of gestation

Secondary Outcome Measures

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

Trial Locations

Locations (1)

An Sinh Hospital; 🇻🇳 Ho Chi Minh, Vietnam