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Evaluate the Interest of the Pre-conceptional Endometrial Immune Profiling to Increase Birth Rates (PRECONCEPTIO)

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ClinicalTrials.gov Identifier: NCT02262117
Recruitment Status : Unknown
Verified August 2016 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was:  Recruiting
First Posted : October 10, 2014
Last Update Posted : August 19, 2016
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:
A prospective, randomized, controlled, open two-arm study to evaluate the interest of the pre-conceptional endometrial immune profiling to increase birth rates.

Condition or disease Intervention/treatment Phase
Reproductive Medicine Other: standard care Drug: specific treatment Not Applicable

Detailed Description:

Birth rates following an embryo transfer with a mean of two embryos transferred stagnate around 23% per transfer (annual report of the Agency of Biomedicine). Some estimates that half of infertile patients treated are partially or totally concerned by problem of inadequate uterine receptivity.

The investigators' hypothesis is that a pre-conceptional immune endometrial evaluation may increase significantly birth rates since successful implantation results from both the matching of a competent embryo within a competent endometrium.

The identification of endometrial biomarkers documenting the immune uterine environment during the implantation window would be able to improve the efficacy of ART through a personalization of treatment accordingly to the ability of the patients to receive their embryos. All patients with all inclusion criteria and no exclusion criteria will be included. Only patients with a deregulation (immune analysis) will be randomized.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Controlled, Two-arm Study to Evaluate the Interest of the Pre-conceptional Endometrial Immune Profiling to Increase Birth Rates Through a Care Personalization in Reproductive Medicine Before IVF
Study Start Date : February 2015
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : April 2018

Arm Intervention/treatment
Placebo Comparator: standard care
No specific treatment (standard care)
Other: standard care
No specific medical care

Experimental: specific treatment
As a deregulation has been diagnosed by immune analysis, a personalization of the medical care for this IVF/ICSI attempt will be dispensed Personalization of treatment should follow a step-to step decision tree.
Drug: specific treatment
Regarding the immune endometrial profiling, medical care (personalization of treatment) should follow a step by step decision tree.




Primary Outcome Measures :
  1. Live birth rate (without congenital abnormality or malformation)/transfer following the first (fresh) embryo transfer after uterine immune analysis [ Time Frame: up to 15 months ]

Secondary Outcome Measures :
  1. Ongoing pregnancy rate/transfer following the first embryo transfer at 12 weeks of amenorrhea [ Time Frame: 12 amenorrhea weeks ]
  2. Number of physiological pregnancies after personalization [ Time Frame: up to 15 months ]
    Physiological pregnancies are defined by a normal growth of the fetus and a birth at term.

  3. Pregnancy rate/transfer following the first embryo transfer [ Time Frame: 8 amenorrhea weeks ]
  4. Number of embryo implanted/number of embryos replaced) [ Time Frame: at 8, 12 and 40 amenorrhea weeks ]
    Implantation rate

  5. Number of early miscarriage in the first trimester [ Time Frame: 12 amenorrhea weeks ]
  6. Number of late miscarriage [ Time Frame: between 13 and 24 amenorrhea weeks ]
  7. Term of birth (for babies without congenital anormality or malformation) [ Time Frame: up to 15 months ]
  8. Weight at birth [ Time Frame: up to 15 months ]
    A weight of birth below the 10 percentile according to the table of reference with distribution of birth weight in function of the term of birth in the overall population define the intrauterine growth retardation (for babies without congenital anormality or malformation)

  9. Number of prematurity (A birth below 37 weeks of amenorrhea defines the premature birth and before 28 weeks of amenorrhea the severe preterm birth) (for babies without congenital anormality or malformation) [ Time Frame: between 28 and 37 amenorrhea weeks ]
  10. Number of pre-eclampsia (defined as the association of hypertension over 14/9 mm of hg with proteinuria occuring during the pregnancy- this pathology is related to insufiscient invasion during the first trimester) [ Time Frame: up to 15 months ]
  11. Number of pathologic pregnancy included stillbirth and congenital abnormality [ Time Frame: up to 15 months ]
  12. Investigate if immunologic events studying on endometrial level have an impact on blood level or are independent. [ Time Frame: up to 15 months ]
    Quantification by flow cytometry of circulating NK cells (CD56 +/CD16 -), T regulatory T cells (FoxP3) with study of the repretory of circulating and uterine NK receptors (NPp46, Nkp30, NKp44).



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Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Infertile patients will be included at the beginning of their medical care in reproduction once the indication to perform either an IVF with or without ICSI has been established. The indication for IVF will be: tubal infertility, endometriosis, ovarian dysovulation with failure of intra-uterine insemination, idiopathic infertility The indication for ICSI will be: male infertility (oligo-astheno-teratospermia), previous failure of oocytes fertilization in IVF
  • Patients should be younger than 38 years old (Age < 38)

    • with a normal ovarian reserve (AMH>1.5ng/ml, FSH<10 IU/l on day-3, antral follicles count (AFC) over 6 on day-3 of the cycle by ultrasound)
    • The range of the IVF or ICSI attempt should be lower than 3 or equal at 2 (first or second IVF/ICSI). If a live birth occurred in the past by IVF/ICSI, the range of the new attempt is 1.
  • With a signed informed and consent form
  • With medical insurance

Exclusion Criteria:

  • Azoospermia or cryptozoospermia (Patient's partner)
  • IVF/ICSI attempt scheduled in another ART unit
  • Contraindication to any experimental treatment (Cortancyl, Intralipids, Human Chorionic Gonadotropin)
  • Maternal serology positive for hepatite C or B

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02262117


Contacts
Contact: Nathalie LEDEE, MD 06 41 67 46 25 nathalie-ledee@orange.fr

Locations
France
Hôpital Saint-Louis - Laboratoire MatriceLAb Innove Recruiting
Paris, France, 75010
Contact: Nathalie LEDEE, MD    06 41 67 46 25    nathalie-ledee@orange.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Nathalie LEDEE, MD Assistance Publique - Hôpitaux de Paris

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02262117     History of Changes
Other Study ID Numbers: P130929
First Posted: October 10, 2014    Key Record Dates
Last Update Posted: August 19, 2016
Last Verified: August 2016

Keywords provided by Assistance Publique - Hôpitaux de Paris:
IVF, pregnancy, immune endometrial profile, personalization of treatment