Gcsf Injection in Women With Repeated Implantaiton Failure

Phase 3

Terminated

• Conditions: Repeated Embryo Implantation Failure
• Interventions: Drug: Filgrastim

• Registration Number: NCT02149277
• Lead Sponsor: Clinique Ovo

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.

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2014-03-19
• Study First Submitted QC: 2014-05-26
• Study First Posted: 2014-05-29
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-25
• Last Update Posted: 2022-04-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Filgrastim	Filgrastim	Injection Filgrastim 300 ug intravaginally during an IVF cycle or during an embryo transfer
Sodium Chloride	Filgrastim	Injection of 1 ml of Sodium Chloride intravaginally during an IVF cycle or during an embryo transfer cycle.

Primary Outcome Measures

Name	Time	Method
Pregnancy and Implantation	up to 3 years	Measure the pregnancy and embryo implantation rate post G-CSF injection
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

Trial Locations

Locations (1)

Clinique Ovo; 🇨🇦 Montreal, Quebec, Canada