Immunophenotypage of RIF and RM Patients and Intrauterine Administration of PBMC

Not Applicable

Withdrawn

• Conditions: Infertility, Female

• Registration Number: NCT04753736
• Lead Sponsor: Fertilys

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-11
• Study First Submitted QC: 2021-02-12
• Study First Posted: 2021-02-15
• Study Start: 2021-09-24
• Primary Completion: 2021-11-01
• Study Completion: 2021-11-01
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-15
• Last Update Posted: 2023-09-18

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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

Trial Locations

Locations (1)

Fertilys; 🇨🇦 Laval, Quebec, Canada