Immunophenotypage of RIF and RM Patients and Intrauterine Administration of PBMC

Fertilys

Overview

The purpose of this study is to identify a systemic immunological profile specific to patients with recurrent implantation failures (RIF) or miscarriages (RM) through blood immunophenotyping on the day of ovulation. This study also aims to determine whether the intrauterine administration of 5 million peripheral blood monocluear cells increases implantation and pregnancy rates in patients with RIF and decreases the risk of miscarriages in patients with RM, compared to what has already been published in the scientific literature

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Conditions

Infertility, Female

Interventions

Intrauterine administration of hCG-activated peripheral blood mononuclear cellsPROCEDURE

Intrauterine administration of hCG-activated peripheral blood mononuclear cells

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * All women aged 18 and over undergoing an IVF cycle with her partner's sperm at the Fertilys fertility center, without a RIF status, agreeing to participate in the study and having signed the consent form to participate in the study. * All women aged 18 and over undergoing an IVF cycle with her partner's sperm at the Fertilys fertility center, with a RIF or RM status, agreeing to participate in the study and having signed the consent form to participate in the study. Exclusion Criteria: * Women who need a gametes donor (eggs and / or sperm). * Women undergoing an IVF cycle with frozen sperm. * Women with autoimmune disease. * Women with diabetes. * Women with a history of chemotherapy treatment.

Locations (1)

Fertilys

Laval, Quebec, Canada

Outcomes

Primary Outcomes

Embryo implantation rate (biochemical pregnancy)

Time frame: Two weeks following embryo transfer or 3 weeks following intrauterine insemination

Clinical pregnancy rate

Time frame: Six to 8 weeks of gestation

Secondary Outcomes

Peripheral blood mononuclear cells populations (PBMC) distribution at Day 0

Time frame: The day 0 of the patient's ovulation

Peripheral blood mononuclear cells populations distribution at Day 2

Time frame: After 48 hours of culture

Cytokines (LIF, IL-6, IL-10, TNFα, FGF-2, VEGF, IL-8) quantification by ELISA in PBMC culture medium at Day 2

Time frame: After 48 hours of culture

Data from ClinicalTrials.gov

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