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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT02250768
Date of registration: 23/09/2014
Prospective Registration: No
Primary sponsor: Vietnam National University
Public title: Effects of Embryogen in RIF Patients RIF
Scientific title: Effects of Granulocyte - Macrophage Colony - Stimulating Factor (GM-CSF) Supplementation in Embryo Culture in Patients With Repeated Implantation Failure
Date of first enrolment: July 2013
Target sample size: 60
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT02250768
Study type:  Interventional
Study design:  Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment  
Phase:  Phase 4
Countries of recruitment
Vietnam
Contacts
Name:     Vinh Q Dang, Dr
Address: 
Telephone:
Email:
Affiliation:  Research Center for Genetics and Reproductive Health
Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 40 Years
Gender: Female
Health Condition(s) or Problem(s) studied
Infertility
Intervention(s)
Biological: GM-CSF
Primary Outcome(s)
ongoing pregnancy rate [Time Frame: 12 week of gestation]
Secondary Outcome(s)
clinical pregnancy rate [Time Frame: 7 week of gestation]
Implantation rate [Time Frame: 7 week of gestation]
top quality embryo rate [Time Frame: 44 hours after insemination]
Secondary ID(s)
CGRH-Embryogen
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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