Gcsf Injection in Women With Repeated Implantaiton Failure

Repeated Embryo Implantation Failure Clinical Trial

Official title:

Effects of Exogenous Recombinant GCSF in Patients With Repeated Implantation Failure - A Randomized Single-blind Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02149277
• Other study ID #: ovo-12-06
• Status: Terminated
• Phase: Phase 3
• Start date: March 2013
• Est. completion date: December 2017

Study information

• Verified date: April 2022
• Source: Clinique Ovo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 37 Years

Eligibility

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

Related Conditions & MeSH terms

• Repeated Embryo Implantation Failure

Intervention

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.

Locations

Country	Name	City	State
Canada	Clinique Ovo	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Clinique Ovo

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Pregnancy and Implantation	Measure the pregnancy and embryo implantation rate post G-CSF injection	up to 3 years