Immunophenotypage of RIF and RM Patients and Intrauterine Administration of PBMC

Intrauterine Administration and Immunophenotyping of Autologous Peripheral Blood Mononuclear Cells in Patients With Repeated Implantation Failures During Undergoing in Vitro Fertilization Treatment

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 Overview

• Status: Withdrawn
• Conditions: Infertility, Female
• Intervention / Treatment: Procedure: Intrauterine administration of hCG-activated peripheral blood mononuclear cells

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fabien Joao, M.Sc; Phone Number: 218 4509349146; Email: fabien.joao@fertilys.org
• Study Contact Backup: Name: Cyntia Duval, PhD; Phone Number: 218 4509349146; Email: cyntia.duval@fertilys.org

Study Locations

• Canada
  • Quebec
    • Laval, Quebec, Canada, H7S1Z5
      • Fertilys
      • Contact: Fabien Joao, M.Sc; Phone Number: 218 4509349146; Email: fabien.joao@fertilys.org
      • Contact: Cyntia Duval, PhD; Phone Number: 218 4509349146; Email: cyntia.duval@fertilys.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No recurrent implantation failure
Experimental: Recurrent implantation failures	Procedure: Intrauterine administration of hCG-activated peripheral blood mononuclear cells; Intrauterine administration of hCG-activated peripheral blood mononuclear cells
Experimental: Recurrent miscarriage	Procedure: Intrauterine administration of hCG-activated peripheral blood mononuclear cells; Intrauterine administration of hCG-activated peripheral blood mononuclear cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Clinical pregnancy rate	Six to 8 weeks of gestation
Embryo implantation rate (biochemical pregnancy)	Two weeks following embryo transfer or 3 weeks following intrauterine insemination

Secondary Outcome Measures

Outcome Measure	Time Frame
Peripheral blood mononuclear cells populations distribution at Day 2	After 48 hours of culture
Peripheral blood mononuclear cells populations (PBMC) distribution at Day 0	The day 0 of the patient's ovulation
Cytokines (LIF, IL-6, IL-10, TNFα, FGF-2, VEGF, IL-8) quantification by ELISA in PBMC culture medium at Day 2	After 48 hours of culture

Collaborators and Investigators

• Sponsor: Fertilys
• Collaborators: Centre hospitalier de l'Université de Montréal (CHUM)

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2021
• Primary Completion (Actual): November 1, 2021
• Study Completion (Actual): November 1, 2021

Study Registration Dates

• First Submitted: February 11, 2021
• First Submitted That Met QC Criteria: February 12, 2021
• First Posted (Actual): February 15, 2021

Study Record Updates

• Last Update Posted (Actual): September 18, 2023
• Last Update Submitted That Met QC Criteria: September 15, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Infertility; Infertility, Female
• Other Study ID Numbers: Immunophenotypage RIF and RM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No