Gcsf Injection in Women With Repeated Implantaiton Failure

Ovo Clinic

Status and phase: Terminated; Phase 3

Conditions: Repeated Embryo Implantation Failure

Treatments: Drug: Filgrastim

Study type: Interventional

Funder types: Industry

Identifiers

NCT02149277

ovo-12-06

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: Female

Ages: 18 to 37 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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15 participants in 2 patient groups, including a placebo group

Filgrastim

Active Comparator group

Description:

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

Treatment:

Drug: Filgrastim

Sodium Chloride

Placebo Comparator group

Description:

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

Treatment:

Drug: Filgrastim