Skip to main content
OpenTrials
Completed

NCT Number: NCT02262117

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Reproductive Medicine

Age range

18 year–38 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Saint-Louis - Laboratoire MatriceLAb Innove

Paris, 75010, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard care

Other

No specific medical care

specific treatment

Drug

Regarding the immune endometrial profiling, medical care (personalization of treatment) should follow a step by step decision tree.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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.

  3. Pregnancy rate/transfer following the first embryo transfer

    Time frame: 8 amenorrhea weeks

    Pregnancy rate/transfer following the first embryo transfer

  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

    Number of early miscarriage in the first trimester

  6. Number of late miscarriage

    Time frame: between 13 and 24 amenorrhea weeks

    Number of late miscarriage

  7. Term of birth (for babies without congenital anormality or malformation)

    Time frame: up to 18 months

    Term of birth

  8. 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)

  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

    Number of prematurity (A birth below 37 weeks of amenorrhea)

  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 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)

  11. Number of pathologic pregnancy included stillbirth and congenital abnormality

    Time frame: up to 18 months

    Number of pathologic pregnancy included stillbirth and congenital abnormality

  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).

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study 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

Acronym: PRECONCEPTIO

Important dates

Study start
2015
Primary completion
2024
Study completion
2024
First posted
Oct 10, 2014
Registry last updated
Jan 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.