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Immunophenotypage of RIF and RM Patients and Intrauterine Administration of PBMC

F

Fertilys

Status

Withdrawn

Conditions

Infertility, Female

Treatments

Procedure: Intrauterine administration of hCG-activated peripheral blood mononuclear cells

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT04753736
Immunophenotypage RIF and RM

Details and patient eligibility

About

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

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 3 patient groups

No recurrent implantation failure
No Intervention group
Recurrent implantation failures
Experimental group
Treatment:
Procedure: Intrauterine administration of hCG-activated peripheral blood mononuclear cells
Recurrent miscarriage
Experimental group
Treatment:
Procedure: Intrauterine administration of hCG-activated peripheral blood mononuclear cells

Trial contacts and locations

1

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Central trial contact

Fabien Joao, M.Sc; Cyntia Duval, PhD

Data sourced from clinicaltrials.gov

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