Immunophenotypage of RIF and RM Patients and Intrauterine Administration of PBMC

Infertility, Female Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04753736
• Other study ID #: Immunophenotypage RIF and RM
• Status: Withdrawn
• Phase: N/A
• Start date: September 24, 2021
• Est. completion date: November 1, 2021

Study information

• Verified date: September 2023
• Source: Fertilys
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 1, 2021
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Infertility
• Infertility, Female

Intervention

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

Locations

Country	Name	City	State
Canada	Fertilys	Laval	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Fertilys	Centre hospitalier de l'Université de Montréal (CHUM)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Embryo implantation rate (biochemical pregnancy)		Two weeks following embryo transfer or 3 weeks following intrauterine insemination
Primary	Clinical pregnancy rate		Six to 8 weeks of gestation
Secondary	Peripheral blood mononuclear cells populations (PBMC) distribution at Day 0		The day 0 of the patient's ovulation
Secondary	Peripheral blood mononuclear cells populations distribution at Day 2		After 48 hours of culture
Secondary	Cytokines (LIF, IL-6, IL-10, TNFa, FGF-2, VEGF, IL-8) quantification by ELISA in PBMC culture medium at Day 2		After 48 hours of culture