Clinical trial NCT02262117: Evaluate the Interest of the Pre-conceptional Endometrial Immune Profiling to Increase Birth Rates
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Reproductive Medicine
Keywords: IVF, immune endometrial profile, treatment personalization
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2014-10-10
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Live birth rate (without congenital abnormality or malformation)/transfer following the first (fresh) embryo transfer after uterine immune analysis
timeFrame: up to 18 months
Secondary outcomes:
measure: Ongoing pregnancy rate/transfer following the first embryo transfer at 12 weeks of amenorrhea
timeFrame: 12 amenorrhea weeks
measure: Number of physiological pregnancies after personalization
timeFrame: up to 18 months
measure: Pregnancy rate/transfer following the first embryo transfer
timeFrame: 8 amenorrhea weeks
measure: Number of embryo implanted/number of embryos replaced)
timeFrame: at 8, 12 and 40 amenorrhea weeks
measure: Number of early miscarriage in the first trimester
timeFrame: 12 amenorrhea weeks
measure: Number of late miscarriage
timeFrame: between 13 and 24 amenorrhea weeks
measure: Term of birth (for babies without congenital anormality or malformation)
timeFrame: up to 18 months
measure: Weight at birth
timeFrame: up to 18 months
measure: 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)
timeFrame: between 28 and 37 amenorrhea weeks
measure: 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)
timeFrame: up to 18 months
measure: Number of pathologic pregnancy included stillbirth and congenital abnormality
timeFrame: up to 18 months
measure: Investigate if immunologic events studying on endometrial level have an impact on blood level or are independent.
timeFrame: up to 15 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Saint-Louis - Laboratoire MatriceLAb Innove
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Nathalie LEDEE, MD
role: PRINCIPAL_INVESTIGATOR
References: