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

Fertilys1 site in 1 countrySeptember 24, 2021

ConditionsInfertility, Female

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Infertility, Female
Sponsor: Fertilys
Locations: 1
Primary Endpoint: Clinical pregnancy rate
Status: Withdrawn
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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

Registry

clinicaltrials.gov

Start Date

September 24, 2021

End Date

November 1, 2021

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Fertilys

Responsible Party

Sponsor

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.

Outcomes

Primary Outcomes

Clinical pregnancy rate

Time Frame: Six to 8 weeks of gestation

Embryo implantation rate (biochemical pregnancy)

Time Frame: Two weeks following embryo transfer or 3 weeks following intrauterine insemination

Secondary Outcomes

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)