Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02262117
Recruitment Status : Recruiting
First Posted : October 10, 2014
Last Update Posted : May 28, 2021
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date  ICMJE October 7, 2014
First Posted Date  ICMJE October 10, 2014
Last Update Posted Date May 28, 2021
Actual Study Start Date  ICMJE February 20, 2015
Estimated Primary Completion Date August 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 17, 2020)
Live birth rate (without congenital abnormality or malformation)/transfer following the first (fresh) embryo transfer after uterine immune analysis [ Time Frame: up to 18 months ]
Live birth rate/transfer
Original Primary Outcome Measures  ICMJE
 (submitted: October 9, 2014)
Live birth rate/transfer following the first embryo transfer [ Time Frame: up to 15 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 17, 2020)
  • Ongoing pregnancy rate/transfer following the first embryo transfer at 12 weeks of amenorrhea [ Time Frame: 12 amenorrhea weeks ]
    Ongoing pregnancy rate/transfer following the first embryo transfer
  • Number of physiological pregnancies after personalization [ Time Frame: up to 18 months ]
    Physiological pregnancies are defined by a normal growth of the fetus and a birth at term.
  • Pregnancy rate/transfer following the first embryo transfer [ Time Frame: 8 amenorrhea weeks ]
    Pregnancy rate/transfer following the first embryo transfer
  • Number of embryo implanted/number of embryos replaced) [ Time Frame: at 8, 12 and 40 amenorrhea weeks ]
    Implantation rate
  • Number of early miscarriage in the first trimester [ Time Frame: 12 amenorrhea weeks ]
    Number of early miscarriage in the first trimester
  • Number of late miscarriage [ Time Frame: between 13 and 24 amenorrhea weeks ]
    Number of late miscarriage
  • Term of birth (for babies without congenital anormality or malformation) [ Time Frame: up to 18 months ]
    Term of birth
  • Weight at birth [ Time Frame: up to 18 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)
  • 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 ]
    Number of prematurity (A birth below 37 weeks of amenorrhea)
  • 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 18 months ]
    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)
  • Number of pathologic pregnancy included stillbirth and congenital abnormality [ Time Frame: up to 18 months ]
    Number of pathologic pregnancy included stillbirth and congenital abnormality
  • 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: October 9, 2014)
  • Ongoing pregnancy rate/transfer following the first embryo transfer at 12 weeks of amenorrhea [ Time Frame: 12 amenorrhea weeks ]
  • 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.
  • Pregnancy rate/transfer following the first embryo transfer [ Time Frame: 8 amenorrhea weeks ]
  • Number of embryo implanted/number of embryos replaced) [ Time Frame: at 8, 12 and 40 amenorrhea weeks ]
    Implantation rate
  • Number of early miscarriage in the first trimester [ Time Frame: 12 amenorrhea weeks ]
  • Number of late miscarriage [ Time Frame: between 13 and 24 amenorrhea weeks ]
  • Term of birth (for babies without congenital anormality or malformation) [ Time Frame: up to 15 months ]
  • 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)
  • 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 ]
  • Number of pre-eclampsia (defined as the association of hypertension over 14/9 mm of hg with proteinury occuring during the pregnancy- this pathology is related to insufiscient invasion during the first trimester) [ Time Frame: up to 15 months ]
  • Number of pathologic pregnancy included stillbirth and congenital abnormality [ Time Frame: up to 15 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluate the Interest of the Pre-conceptional Endometrial Immune Profiling to Increase Birth Rates
Official Title  ICMJE 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
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Reproductive Medicine
Intervention  ICMJE
  • Other: standard care
    No specific medical care
  • Drug: specific treatment
    Regarding the immune endometrial profiling, medical care (personalization of treatment) should follow a step by step decision tree.
Study Arms  ICMJE
  • Placebo Comparator: standard care
    No specific treatment (standard care)
    Intervention: Other: standard 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.
    Intervention: Drug: specific treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 9, 2014)
400
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2024
Estimated Primary Completion Date August 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 38 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Nathalie LEDEE, MD 06 41 67 46 25 nathalie-ledee@orange.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02262117
Other Study ID Numbers  ICMJE P130929
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nathalie LEDEE, MD Assistance Publique - Hôpitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP