Effects of Embryogen in RIF Patients (RIF)
Primary Purpose
Infertility
Status
Completed
Phase
Phase 4
Locations
Vietnam
Study Type
Interventional
Intervention
GM-CSF
Sponsored by
About this trial
This is an interventional treatment trial for Infertility focused on measuring GM-CSF, repeated implantation failure
Eligibility 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
Sites / Locations
- An Sinh Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
GM-CSF
Arm Description
Injected oocytes were cultured in GM-CSF supplemented media until day of transfer
Outcomes
Primary Outcome Measures
ongoing pregnancy rate
Secondary Outcome Measures
Implantation rate
clinical pregnancy rate
top quality embryo rate
Full Information
NCT ID
NCT02250768
First Posted
September 23, 2014
Last Updated
September 23, 2014
Sponsor
Vietnam National University
1. Study Identification
Unique Protocol Identification Number
NCT02250768
Brief Title
Effects of Embryogen in RIF Patients
Acronym
RIF
Official Title
Effects of Granulocyte - Macrophage Colony - Stimulating Factor (GM-CSF) Supplementation in Embryo Culture in Patients With Repeated Implantation Failure
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vietnam National University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
GM-CSF, repeated implantation failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GM-CSF
Arm Type
Experimental
Arm Description
Injected oocytes were cultured in GM-CSF supplemented media until day of transfer
Intervention Type
Biological
Intervention Name(s)
GM-CSF
Intervention Description
2ng/ml of GM-CSF supplemented into culture media
Primary Outcome Measure Information:
Title
ongoing pregnancy rate
Time Frame
12 week of gestation
Secondary Outcome Measure Information:
Title
Implantation rate
Time Frame
7 week of gestation
Title
clinical pregnancy rate
Time Frame
7 week of gestation
Title
top quality embryo rate
Time Frame
44 hours after insemination
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vinh Q Dang, Dr
Organizational Affiliation
Research Center for Genetics and Reproductive Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
An Sinh Hospital
City
Ho Chi Minh
Country
Vietnam
12. IPD Sharing Statement
Learn more about this trial
Effects of Embryogen in RIF Patients
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