Immunophenotypage of RIF and RM Patients and Intrauterine Administration of PBMC

NCT04753736 | Withdrawn

• 1 other identifier: Immunophenotypage RIF and RM
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Infertility, Female

Outcome Measures

Primary Outcomes (2)

• Embryo implantation rate (biochemical pregnancy)

  Two weeks following embryo transfer or 3 weeks following intrauterine insemination

• Clinical pregnancy rate

  Six to 8 weeks of gestation

Secondary Outcomes (3)

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

  The day 0 of the patient's ovulation

• Peripheral blood mononuclear cells populations distribution at Day 2

  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

  After 48 hours of culture

Study Arms (3)

No recurrent implantation failure

NO INTERVENTION

Recurrent implantation failures

EXPERIMENTAL

Procedure: Intrauterine administration of hCG-activated peripheral blood mononuclear cells

Recurrent miscarriage

EXPERIMENTAL

Procedure: Intrauterine administration of hCG-activated peripheral blood mononuclear cells

Interventions

Intrauterine administration of hCG-activated peripheral blood mononuclear cells PROCEDURE

Intrauterine administration of hCG-activated peripheral blood mononuclear cells

Recurrent implantation failures; Recurrent miscarriage

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fertilys: lead
• Centre hospitalier de l'Université de Montréal (CHUM): collaborator

Study Sites (1)

Fertilys

Laval, Quebec, H7S1Z5, Canada

Location

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2021
• First Posted: February 15, 2021
• Study Start: September 24, 2021
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2021
• Last Updated: September 18, 2023

Record last verified: 2023-09

Locations

CA (1)