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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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04753736
Enrollment
0
Registered
2021-02-15
Start date
2021-09-24
Completion date
2021-11-01
Last updated
2023-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility, Female

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

Interventions

Intrauterine administration of hCG-activated peripheral blood mononuclear cells

Sponsors

Centre hospitalier de l'Université de Montréal (CHUM)
CollaboratorOTHER
Fertilys
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Embryo implantation rate (biochemical pregnancy)Two weeks following embryo transfer or 3 weeks following intrauterine insemination
Clinical pregnancy rateSix to 8 weeks of gestation

Secondary

MeasureTime frame
Peripheral blood mononuclear cells populations (PBMC) distribution at Day 0The day 0 of the patient's ovulation
Peripheral blood mononuclear cells populations distribution at Day 2After 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 2After 48 hours of culture

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026