NCT02250768

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2013

Shorter than P25 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 26, 2014

Completed
Last Updated

September 26, 2014

Status Verified

September 1, 2014

Enrollment Period

8 months

First QC Date

September 23, 2014

Last Update Submit

September 23, 2014

Conditions

Infertility

Keywords

GM-CSF, repeated implantation failure

Outcome Measures

Primary Outcomes (1)

  • ongoing pregnancy rate

    12 week of gestation

Secondary Outcomes (3)

  • Implantation rate

    7 week of gestation

  • clinical pregnancy rate

    7 week of gestation

  • top quality embryo rate

    44 hours after insemination

Study Arms (1)

GM-CSF

EXPERIMENTAL

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

Biological: GM-CSF

Interventions

GM-CSFBIOLOGICAL

2ng/ml of GM-CSF supplemented into culture media

GM-CSF

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

An Sinh Hospital

Ho Chi Minh City, Ho Chi Minh, Vietnam

Location

An Sinh Hospital

Ho Chi Minh City, Vietnam

Location

MeSH Terms

Conditions

Infertility

Interventions

Granulocyte-Macrophage Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Vinh Q Dang, Dr

    Research Center for Genetics and Reproductive Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

September 23, 2014

First Posted

September 26, 2014

Study Start

July 1, 2013

Primary Completion

March 1, 2014

Study Completion

August 1, 2014

Last Updated

September 26, 2014

Record last verified: 2014-09

Locations

VN(2)