NCT02262117

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 7, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 10, 2014

Completed
1.1 years until next milestone

Study Start

First participant enrolled

October 30, 2015

Completed
8.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 22, 2024

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

January 29, 2025

Status Verified

January 1, 2025

Enrollment Period

8.4 years

First QC Date

October 7, 2014

Last Update Submit

January 27, 2025

Conditions

Reproductive Medicine

Keywords

IVF, immune endometrial profile, treatment personalization

Outcome Measures

Primary Outcomes (1)

  • Live birth rate (without congenital abnormality or malformation)/transfer following the first (fresh) embryo transfer after uterine immune analysis

    Live birth rate/transfer

    up to 18 months

Secondary Outcomes (12)

  • Ongoing pregnancy rate/transfer following the first embryo transfer at 12 weeks of amenorrhea

    12 amenorrhea weeks

  • Number of physiological pregnancies after personalization

    up to 18 months

  • Pregnancy rate/transfer following the first embryo transfer

    8 amenorrhea weeks

  • Number of embryo implanted/number of embryos replaced)

    at 8, 12 and 40 amenorrhea weeks

  • Number of early miscarriage in the first trimester

    12 amenorrhea weeks

  • +7 more secondary outcomes

Study Arms (2)

standard care

PLACEBO COMPARATOR

No specific treatment (standard care)

Other: standard care

specific treatment

EXPERIMENTAL

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.

Drug: specific treatment

Interventions

standard careOTHER

No specific medical care

standard care
specific treatmentDRUG

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

specific treatment

Eligibility Criteria

Age18 Years - 38 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Saint-Louis - Laboratoire MatriceLAb Innove

Paris, 75010, France

Location

Related Publications (1)

  • Ledee N, Petitbarat M, Dray G, Chevrier L, Kazhalawi A, Rahmati M, Vicaut E, Diallo A, Cassuto NG, Ruoso L, Prat-Ellenberg L. Endometrial immune profiling and precision therapy increase live birth rate after embryo transfer: a randomised controlled trial. Front Immunol. 2025 Feb 24;16:1523871. doi: 10.3389/fimmu.2025.1523871. eCollection 2025.

    PMID: 40066441DERIVED

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Nathalie LEDEE, MD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2014

First Posted

October 10, 2014

Study Start

October 30, 2015

Primary Completion

March 22, 2024

Study Completion

April 1, 2024

Last Updated

January 29, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)