Gcsf Injection in Women With Repeated Implantaiton Failure

NCT ID: NCT02149277

Last Updated: 2022-04-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2017-12-31

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.

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.

Conditions

Repeated Embryo Implantation Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Filgrastim

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

Group Type: ACTIVE_COMPARATOR

Filgrastim

Intervention Type: 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.

Sodium Chloride

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

Group Type: PLACEBO_COMPARATOR

Filgrastim

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Neupogen

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 37 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Clinique Ovo

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jacques Kadoch, Md

Role: PRINCIPAL_INVESTIGATOR

Clinique Ovo

Locations

Clinique Ovo

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

ovo-12-06

Identifier Type: -

Identifier Source: org_study_id