Immunophenotypage of RIF and RM Patients and Intrauterine Administration of PBMC

Study Overview
=================
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

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

Conditions
-----------------
Infertility, Female

Intervention / Treatment
-----------------
* Procedure: Intrauterine administration of hCG-activated peripheral blood mononuclear cells


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No recurrent implantation failure<br> | |
| Experimental: Recurrent implantation failures<br> | Procedure: Intrauterine administration of hCG-activated peripheral blood mononuclear cells<br>* Intrauterine administration of hCG-activated peripheral blood mononuclear cells<br>|
| Experimental: Recurrent miscarriage<br> | Procedure: Intrauterine administration of hCG-activated peripheral blood mononuclear cells<br>* Intrauterine administration of hCG-activated peripheral blood mononuclear cells<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Embryo implantation rate (biochemical pregnancy) |  | Two weeks following embryo transfer or 3 weeks following intrauterine insemination | 
| Clinical pregnancy rate |  | Six to 8 weeks of gestation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peripheral blood mononuclear cells populations (PBMC) distribution at Day 0 |  | The day 0 of the patient's ovulation | 
| Peripheral blood mononuclear cells populations distribution at Day 2 |  | After 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 2 |  | After 48 hours of culture |