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NCT Number: NCT06503952

Impact of Uterine Immune Profiling and Personalized Treatments in Patients Receiving a Single Blastocyst: a Matched Controlled Study

A recent randomised controlled trial and previous large cohort studies have shown that the uterine immune environment is a crucial element in improving the performance of Assisted Reproductive therapy (ART). As previous studies mixed Day-3, Day-5, single or doble embryo transfer, the clear influence of the endometrial environment on the embryo itself and its type of transfer (fresh or freeze thawed) need further investigation.

To complement previous studies, the present matched- pair study aims to select the population who exclusively received a single Day-5 embryo transfer (SET) and benefitted of a uterine immune profiling between 1 January 2020 and 30 June 2023 before the SET Day-5.

This population will be matched to a population. who did not have uterine immune profiling in the nine months prior to the single Day 5 embryo transfer between 2018 and 2023.

The matching criteria are the maternal age (+/-1 year), the past history of ART (same number of previous oocytes pick-up, same number of previous embryo transfer) and the same type of transfer (IVF, ICSI, frozen transfer) and the same category of expansion of the blastocoel (B1-B2/ B3-B4/ B5-B6).

The primary end-point is the live birth rate (LBR) following the Day 5 SET in the population who benefited from pre-SET immune profiling versus the LBR following the Day 5 SET in the pair- matched population who did not benefit from pre-SET uterine immune profiling Secondary end point are the clinical pregnancy rate and miscarriage rate per SET in the two paired populations

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Key information

Age range

18 year–41 year

Sex eligibility

Female

Study type

Observational

Primary location

Hopital des Bluets- centre d'assistance medicale à la procreation, Paris, Ile de, France

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About this study

The PRECONCEPTIO software will be used to extract all the uterine immune profiles carried out between January 2020 and June 2023 for patients attending the two reproductive centres, Bluets and Diaconnesse.

In parallel, data will be extracted from the MEDIFIRST software selecting all patients who benefited from a single day 5 embryo transfer between January 2018 and March 2024.

The case group represents the selection of patients who had both uterine immune profiling prior to ET and Day 5 single embryo transfer within the nine months following uterine immune profiling.

Each patient in the treated group is matched to patients who had a single Day 5 ET without immune profiling in the nine months prior to ET.

Matching criteria will be maternal age (+/-1year) and, number of previous egg retrievals (including the ones without any transfer) and, number of previous ETs and technique used (IVF, ICSI, frozen embryo transfer) and degree of expansion of blastocoel (B1-B2/B3-B4/B5-B6) to reflect the quality of the embryo transferred The primary end-point is the live birth rate (LBR) following the Day 5 SET in the population who benefited from pre-SET immune profiling versus the LBR following the Day 5 SET in the pair- matched population who did not benefit from pre-SET uterine immune profiling Secondary end point are the clinical pregnancy rate and miscarriage rate per SET in the two paired populations

Impact of the uterine immune profiling on the live birth rate

  • In function of the type of embryo transfer (fresh or freezed thawed)
  • In function of the quality of the blastocyst transferred
  • In function of the range of embryo transfer

Who can participate

Healthy volunteers accepted: No

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

For case: Uterine immune profiling followed by a Day-5 fresh SET or day-5 or Day-6 freeze-thawed SET within the nine months following the uterine immune profiling between January 2020 and June 2023.

Will be excluded patients with no SET day-5, with uterine immune profiling more than nine months before, or with no matching pair For control: Blastocyst SET without uterine immune profiling within the year prior the embryo transfer matched to the case group between January 2018 on June 2023

  • maternal age (+/-1 year) and
  • the past history of ART (same number of previous oocytes pick-up, same number of previous embryo transfer) and
  • the same type of transfer (IVF, ICSI, frozen transfer) and
  • the same category of expansion of the blastocoel (B1-B2/ B3-B4/ B5-B6).

Treatment and study plan

Primary outcomes

  1. Live birth rate following the single Day-5 embryo transfer (ET)

    Time frame: 9 months after the ET

    Live birth rate following the Day-5 ET between the case and control groups

Secondary outcomes

  1. Implantation rate following the Day-5 ET

    Time frame: one month after ET

    Implantation rate following the Day-5 ET between the case and control groups

  2. Clinical pregnancy rate after the Day-5 ET

    Time frame: two weeks after ET

    Clinical pregnancy rate after the Day-5 ET between the case and control groups

  3. Ongoing PR after the day-5 ET

    Time frame: 12 weeks after ET

    Ongoing PR after the day-5 ET between the case and control groups

  4. Miscarriage rate after ET

    Time frame: 20 weeks after the ET

    Miscarriage rate after the Blastocyst SET in the case and the pair-matched group

Study contacts

Contact information is provided by the study sponsor or research team.

Nathalie LEDEE, MD, PhD

CONTACT

[email protected]

+33681560394

Nathalie Lédée, MD, PhD

CONTACT

[email protected]

33681560394

Sponsors and collaborators

Lead sponsor

Matricelab Innove

Other

Registry information

Official study title

Impact of Uterine Immune Profiling and Personalized Treatments on Subsequent Live Birth in Patients Receiving a Single Blastocyst: a Matched Controlled Study

Acronym: UTIMPROSET

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 16, 2024
Registry last updated
Dec 27, 2024

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.

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