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

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Reproductive Medicine

Treatments: Drug: specific treatment; Other: standard care

Study type: Interventional

Funder types: Other

Identifiers

NCT02262117

P130929

Details and patient eligibility

About

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

Full 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.

Enrollment: 400 estimated patients

Sex: Female

Ages: 18 to 38 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups, including a placebo group

standard care

Placebo Comparator group

Description:

No specific treatment (standard care)

Treatment:

Other: standard care

specific treatment

Experimental group

Description:

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.

Treatment:

Drug: specific treatment