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Gcsf Injection in Women With Repeated Implantaiton Failure

Sponsor
Clinique Ovo (Industry)
Overall Status
Terminated
CT.gov ID
NCT02149277
Collaborator
(none)
15
Enrollment
1
Location
2
Arms
57
Actual Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the study is to see the impact of intrauterine injection of recombinant GCSF on pregnancy and implantation rate during IVF-ICSI (intracytoplasmic sperm injection) protocols as well as in frozen embryo transfer. In addition, following the injection, the level of G-CSF in the bloodstream will be verified.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

Recently, scientists have been interested in G-CSF (Granulocyte - Colony Stimulating Factor) and the latter has seen its use grow in reproductive pathology.

G -CSF, a true center pivot, would act concurrently on oocyte quality and endometrial receptivity, improving:

  • Immune tolerance

  • The self-healing of oocyte chromosome abnormalities

  • The adherence of the embryo

The injection of G-CSF molecule has been used in different circumstances. One of its uses, among others, is to help rebuild the immune system in patients undergoing chemotherapy. Some studies have been conducted in patients having embryo implantation problems; they have demonstrated improved rates of pregnancy and childbirth after treatment.

Study Design

Study Type:
Interventional
Actual Enrollment :
15 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Effects of Exogenous Recombinant GCSF in Patients With Repeated Implantation Failure - A Randomized Single-blind Trial
Actual Study Start Date :
Mar 1, 2013
Actual Primary Completion Date :
Dec 1, 2017
Actual Study Completion Date :
Dec 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Filgrastim

Injection Filgrastim 300 ug intravaginally during an IVF cycle or during an embryo transfer

Drug: Filgrastim
The fertility specialist will inject the study medication or its placebo on the 6th day of gonadotrophin stimulation for IVF subjects. For the subjects undergoing embryo transfer, the injection will be done once the endometrial lining measure more than 8mm.
Other Names:
  • Neupogen

    		•
    Placebo Comparator: Sodium Chloride

    Injection of 1 ml of Sodium Chloride intravaginally during an IVF cycle or during an embryo transfer cycle.

    Drug: Filgrastim
    The fertility specialist will inject the study medication or its placebo on the 6th day of gonadotrophin stimulation for IVF subjects. For the subjects undergoing embryo transfer, the injection will be done once the endometrial lining measure more than 8mm.
    Other Names:
  • Neupogen

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Dosage of G-CSF [up to 3 years]

      Measure dosage of G-CSF in the bloodstream on the day of oocyte retrieval and measure the implantation rate as well as pregnancy rate following the G-CSF injection

    2. Pregnancy and Implantation [up to 3 years]

      Measure the pregnancy and embryo implantation rate post G-CSF injection

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 37 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Women between the ages of 18 and 37

    • Indication of the Antagonist IVF protocol or indication of a substituted frozen embryo transfer

    • Subjects with repetitive embryo implantation failure meaning: a history of 3 embryos transferred including frozen embryo without a positive pregnancy test for women 35 years and younger

    • Subjects with repetitive embryo implantation failure meaning: a history of 4 embryos transferred including frozen embryo without a positive pregnancy test for women between the ages of 35 and 37.

    • Negative repetitive implantation failure work up

    Exclusion Criteria:

    • Renal failure or cardiac failure

    • Chronic neutropenia

    • Past or present cancer history

    • Sickle cell anemia

    • Lithium treatment

    • Voluntary withdrawal from the study

    • Use of concomitant medication: DHEA (dehydroepiandrosterone ), CoQ10 (coenzyme Q10), Growth Hormone and Viagra

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Clinique Ovo Montreal Quebec Canada H4P 2S4

    Sponsors and Collaborators

    • Clinique Ovo

    Investigators

    • Principal Investigator: Jacques Kadoch, Md, Clinique Ovo

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Clinique Ovo
    ClinicalTrials.gov Identifier:
    NCT02149277
    Other Study ID Numbers:
    • ovo-12-06
    First Posted:
    May 29, 2014
    Last Update Posted:
    Apr 27, 2022
    Last Verified:
    Apr 1, 2022
    Keywords provided by Clinique Ovo
    Infertility
    IVF
    Embryo transfer
    Additional relevant MeSH terms:
    Lenograstim

    Study Results

    No Results Posted as of Apr 27, 2022