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

Not Applicable

Completed

• Conditions: Reproductive Medicine
• Interventions: Other: standard care; Drug: specific treatment

• Registration Number: NCT02262117
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2014-10-07
• Study First Submitted QC: 2014-10-09
• Study First Posted: 2014-10-10
• Study Start: 2015-10-30
• Primary Completion: 2024-03-22
• Study Completion: 2024-04
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-27
• Last Update Posted: 2025-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard care	standard care	No specific treatment (standard care)
specific treatment	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.

Primary Outcome Measures

Name	Time	Method
Live birth rate (without congenital abnormality or malformation)/transfer following the first (fresh) embryo transfer after uterine immune analysis	up to 18 months	Live birth rate/transfer

Secondary Outcome Measures

Name	Time	Method
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)	between 28 and 37 amenorrhea weeks	Number of prematurity (A birth below 37 weeks of amenorrhea)
Ongoing pregnancy rate/transfer following the first embryo transfer at 12 weeks of amenorrhea	12 amenorrhea weeks	Ongoing pregnancy rate/transfer following the first embryo transfer
Number of physiological pregnancies after personalization	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	8 amenorrhea weeks	Pregnancy rate/transfer following the first embryo transfer
Number of embryo implanted/number of embryos replaced)	at 8, 12 and 40 amenorrhea weeks	Implantation rate
Number of late miscarriage	between 13 and 24 amenorrhea weeks	Number of late miscarriage
Weight at birth	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 pathologic pregnancy included stillbirth and congenital abnormality	up to 18 months	Number of pathologic pregnancy included stillbirth and congenital abnormality
Number of early miscarriage in the first trimester	12 amenorrhea weeks	Number of early miscarriage in the first trimester
Term of birth (for babies without congenital anormality or malformation)	up to 18 months	Term of birth
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)	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)
Investigate if immunologic events studying on endometrial level have an impact on blood level or are independent.	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).

Trial Locations

Locations (1)

Hôpital Saint-Louis - Laboratoire MatriceLAb Innove; 🇫🇷 Paris, France