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Cell Therapy
Intrauterine administration of hCG-activated peripheral blood mononuclear cells for Female Infertility
N/A
Waitlist Available
Research Sponsored by Fertilys
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after 48 hours of culture
Awards & highlights
Study Summary
This trial is testing whether giving extra immune cells to people with fertility issues can help them get pregnant and carry to term.
Eligible Conditions
- Female Infertility
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ after 48 hours of culture
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after 48 hours of culture
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinical pregnancy rate
Embryo implantation rate (biochemical pregnancy)
Secondary outcome measures
Cytokines (LIF, IL-6, IL-10, TNFα, FGF-2, VEGF, IL-8) quantification by ELISA in PBMC culture medium at Day 2
Peripheral blood mononuclear cells populations (PBMC) distribution at Day 0
Peripheral blood mononuclear cells populations distribution at Day 2
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Recurrent miscarriageExperimental Treatment1 Intervention
Group II: Recurrent implantation failuresExperimental Treatment1 Intervention
Group III: No recurrent implantation failureActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intrauterine administration of hCG-activated peripheral blood mononuclear cells
2017
N/A
~430
Find a Location
Who is running the clinical trial?
Centre hospitalier de l'Université de Montréal (CHUM)OTHER
370 Previous Clinical Trials
129,869 Total Patients Enrolled
FertilysLead Sponsor
3 Previous Clinical Trials
675 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Women who require donated eggs or sperm to become pregnant.Women with a condition where their immune system attacks their own body.Women who have diabetes.
Research Study Groups:
This trial has the following groups:- Group 1: Recurrent miscarriage
- Group 2: Recurrent implantation failures
- Group 3: No recurrent implantation failure
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Female Infertility Patient Testimony for trial: Trial Name: NCT04753736 — N/A
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