InfertilityUTIMPROSETNCT06503952
Impact of Uterine Immune Profiling and Personalized Treatments in Patients Receiving a Single Blastocyst: a Matched Controlled Study
An observational study of Infertility and Success Rate of Assisted Reproductive Therapy, run by Matricelab Innove at 2 sites in France.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 41 years, women only
- Conditions the study is for
- Infertility, Success Rate of Assisted Reproductive Therapy, Single Embryo Transfer
- How many people
- 340 participants
- Where
- 2 sitesFrance
- Study dates
- 15 Jan 2025to 30 May 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 41 years
- Women only
- No healthy volunteers
- Adult
Study population: Patients with a single embryo transfer at Day-5 case group: With an immune profile within the nine month before ET Control group: without immune profiling performed
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).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites
Hopital des Bluets- centre d'assistance medicale à la procreation
Paris, Ile de, 75012
Nathalie Lédée, MD, PhD, 33681560394, nathalie-ledee@orange.fr
Laura Prat-Ellenberg, MD, +330669580724, laura.prat-ellenberg@bluets.org
Hopital des diaconnesse- Centre d'assistance medicale a la procreation
Paris, Île-de-France Region, 75012
Gwenola KEROMNES, MD, +33662106322, gkeromnes@hopital-dcss.org
Gwenola Keromnes, MD
About this study
Official title: Impact of Uterine Immune Profiling and Personalized Treatments on Subsequent Live Birth 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.
Read more
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
Read the detailed description
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
- Conditions
- Infertility, Success Rate of Assisted Reproductive Therapy, Single Embryo Transfer, Pregnancy Outcomes, Immunological Tolerance, Immune System
- Keywords
- infertility, success rate of assisted reproductibve therapy, Single embryo transfer, uterine immune profiling, personalized care, Live birth rate
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| case group | Case group: All the patients who would have benefitted (with informed consent) of a uterine immune profile and a fresh Day-5 SET or a day-5 or-6 SET between January 2020 and march 2024 would be enrolled | |
| control group | Pair-matched group: Group without uterine immune profile before the SET 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live birth rate following the single Day-5 embryo transfer (ET)
Live birth rate following the Day-5 ET between the case and control groups
Measured: 9 months after the ET
Secondary outcomes (4)
Implantation rate following the Day-5 ET
Implantation rate following the Day-5 ET between the case and control groups
Measured: one month after ET
Clinical pregnancy rate after the Day-5 ET
Clinical pregnancy rate after the Day-5 ET between the case and control groups
Measured: two weeks after ET
Ongoing PR after the day-5 ET
Ongoing PR after the day-5 ET between the case and control groups
Measured: 12 weeks after ET
Miscarriage rate after ET
Miscarriage rate after the Blastocyst SET in the case and the pair-matched group
Measured: 20 weeks after the ET
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start15 Jan 2025 (estimated)
- Primary completion30 Apr 2025 (estimated)
- Study completion30 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Matricelab Innove
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Nathalie Lédée, Matricelab Innove
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06503952
- Sponsor's protocol ID
- MatriceLab Innove
- Acronym
- UTIMPROSET
- Status last verified
- Dec 2024
- First submitted
- 10 Jul 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Uterine Immune Profiling and Personalized Treatments on Subsequent Live Birth in Patients Receiving a Single Blastocyst: a Matched Controlled Study
- ClinicalTrials.gov ID
- NCT06503952
- Acronym / sponsor ID
- UTIMPROSET / MatriceLab Innove
- Conditions
- Infertility, Success Rate of Assisted Reproductive Therapy, Single Embryo Transfer, Pregnancy Outcomes, Immunological Tolerance, Immune System
- Keywords
- infertility, success rate of assisted reproductibve therapy, Single embryo transfer, uterine immune profiling, personalized care, Live birth rate
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- Matricelab InnoveUniversity, hospital or other
- Study start
- 15 Jan 2025 (estimated)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 16 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| case group | – | –Case group: All the patients who would have benefitted (with informed consent) of a uterine immune profile and a fresh Day-5 SET or a day-5 or-6 SET between January 2020 and march 2024 would be enrolled |
| control group | – | –Pair-matched group: Group without uterine immune profile before the SET 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 |
Who may qualify
- Ages
- 18 to 41 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with a single embryo transfer at Day-5 case group: With an immune profile within the nine month before ET Control group: without immune profiling performed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
4 secondary outcomes
Implantation rate following the Day-5 ET
Time frame: one month after ET
Clinical pregnancy rate after the Day-5 ET
Time frame: two weeks after ET
Ongoing PR after the day-5 ET
Time frame: 12 weeks after ET
Miscarriage rate after ET
Time frame: 20 weeks after the ET
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- review on uterine immune profilingLink provided by the sponsor.
- cohort study on uterine immune profilingLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility and Success Rate of Assisted Reproductive Therapy, run by Matricelab Innove at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nathalie Lédée, MD, PhD (33681560394, nathalie.ledee@matricelabinnove.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Live birth rate following the single Day-5 embryo transfer (ET) (time frame: 9 months after the ET). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.