Gcsf Injection in Women With Repeated Implantaiton Failure

NCT02149277 | Terminated Phase 3

• 1 other identifier: ovo-12-06
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Repeated Embryo Implantation Failure

Keywords

Infertility; IVF; Embryo transfer

Outcome Measures

Primary Outcomes (2)

• Dosage of G-CSF

  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

  up to 3 years

• Pregnancy and Implantation

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

  up to 3 years

Study Arms (2)

Filgrastim

ACTIVE COMPARATOR

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

Drug: Filgrastim

Sodium Chloride

PLACEBO COMPARATOR

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

Drug: Filgrastim

Interventions

Filgrastim DRUG

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.

Also known as: Neupogen

Filgrastim; Sodium Chloride

Eligibility Criteria

• Age: 18 Years - 37 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinique Ovo: lead

Study Sites (1)

Clinique Ovo

Montreal, Quebec, H4P 2S4, Canada

Location

MeSH Terms

Conditions

Infertility

Interventions

Filgrastim

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Jacques Kadoch, Md

  Clinique Ovo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2014
• First Posted: May 29, 2014
• Study Start: March 1, 2013
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: April 27, 2022

Record last verified: 2022-04

Locations

CA (1)