Back to resultsImmunophenotypage of RIF and RM Patients and Intrauterine Administration of PBMC
Primary Purpose
Infertility, Female
Status
Withdrawn
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Intrauterine administration of hCG-activated peripheral blood mononuclear cells
Sponsored by
About this trial
This is an interventional diagnostic trial for Infertility, Female
Eligibility Criteria
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.
Sites / Locations
- Fertilys
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
No recurrent implantation failure
Recurrent implantation failures
Recurrent miscarriage
Arm Description
Outcomes
Primary Outcome Measures
Embryo implantation rate (biochemical pregnancy)
Clinical pregnancy rate
Secondary Outcome Measures
Peripheral blood mononuclear cells populations (PBMC) distribution at Day 0
Peripheral blood mononuclear cells populations distribution at Day 2
Cytokines (LIF, IL-6, IL-10, TNFα, FGF-2, VEGF, IL-8) quantification by ELISA in PBMC culture medium at Day 2
Full Information
NCT ID
NCT04753736
First Posted
February 11, 2021
Last Updated
September 15, 2023
Sponsor
Fertilys
Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
1. Study Identification
Unique Protocol Identification Number
NCT04753736
Brief Title
Immunophenotypage of RIF and RM Patients and Intrauterine Administration of PBMC
Official Title
Intrauterine Administration and Immunophenotyping of Autologous Peripheral Blood Mononuclear Cells in Patients With Repeated Implantation Failures During Undergoing in Vitro Fertilization Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Withdrawn
Why Stopped
lack of staff
Study Start Date
September 24, 2021 (Actual)
Primary Completion Date
November 1, 2021 (Actual)
Study Completion Date
November 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fertilys
Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Female
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
No recurrent implantation failure
Arm Type
No Intervention
Arm Title
Recurrent implantation failures
Arm Type
Experimental
Arm Title
Recurrent miscarriage
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Intrauterine administration of hCG-activated peripheral blood mononuclear cells
Intervention Description
Intrauterine administration of hCG-activated peripheral blood mononuclear cells
Primary Outcome Measure Information:
Title
Embryo implantation rate (biochemical pregnancy)
Time Frame
Two weeks following embryo transfer or 3 weeks following intrauterine insemination
Title
Clinical pregnancy rate
Time Frame
Six to 8 weeks of gestation
Secondary Outcome Measure Information:
Title
Peripheral blood mononuclear cells populations (PBMC) distribution at Day 0
Time Frame
The day 0 of the patient's ovulation
Title
Peripheral blood mononuclear cells populations distribution at Day 2
Time Frame
After 48 hours of culture
Title
Cytokines (LIF, IL-6, IL-10, TNFα, FGF-2, VEGF, IL-8) quantification by ELISA in PBMC culture medium at Day 2
Time Frame
After 48 hours of culture
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Fertilys
City
Laval
State/Province
Quebec
ZIP/Postal Code
H7S1Z5
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Immunophenotypage of RIF and RM Patients and Intrauterine Administration of PBMC
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