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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
Vietnam National University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring GM-CSF, repeated implantation failure

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts 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

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

First Posted
September 23, 2014
Last Updated
September 23, 2014
Sponsor
Vietnam National University
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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

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Effects of Embryogen in RIF Patients

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