Reproductive MedicinePRECONCEPTIONCT02262117
Evaluate the Interest of the Pre-conceptional Endometrial Immune Profiling to Increase Birth Rates
A study testing specific treatment in people with Reproductive Medicine, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
A prospective, randomized, controlled, open two-arm study to evaluate the interest of the pre-conceptional endometrial immune profiling to increase birth rates. Read more about this study
- Who is it for?
- Ages 18 to 38 years, women only
- Conditions the study is for
- Reproductive Medicine
- What is being tested?
- specific treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 493 participants
- Where
- 1 siteFrance
- Study dates
- 30 Oct 2015to Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomized, Controlled, Two-arm Study to Evaluate the Interest of the Pre-conceptional Endometrial Immune Profiling to Increase Birth Rates Through a Care Personalization in Reproductive Medicine Before IVF
A prospective, randomized, controlled, open two-arm study to evaluate the interest of the pre-conceptional endometrial immune profiling to increase birth rates.
Read the 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.
- Conditions
- Reproductive Medicine
- Being tested
- standard care, specific treatment
- Keywords
- IVF, immune endometrial profile, treatment personalization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard careOther
No specific medical care
specific treatmentDrug
Regarding the immune endometrial profiling, medical care (personalization of treatment) should follow a step by step decision tree.
| Study group | Role | What they receive |
|---|---|---|
| standard care | Placebo comparator | No specific treatment (standard care) Receives: 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. Receives: Drug: specific treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live birth rate (without congenital abnormality or malformation)/transfer following the first (fresh) embryo transfer after uterine immune analysis
Live birth rate/transfer
Measured: up to 18 months
Secondary outcomes (12)
Ongoing pregnancy rate/transfer following the first embryo transfer at 12 weeks of amenorrhea
Ongoing pregnancy rate/transfer following the first embryo transfer
Measured: 12 amenorrhea weeks
Number of physiological pregnancies after personalization
Physiological pregnancies are defined by a normal growth of the fetus and a birth at term.
Measured: up to 18 months
Pregnancy rate/transfer following the first embryo transfer
Pregnancy rate/transfer following the first embryo transfer
Measured: 8 amenorrhea weeks
Number of embryo implanted/number of embryos replaced)
Implantation rate
Measured: at 8, 12 and 40 amenorrhea weeks
Number of early miscarriage in the first trimester
Number of early miscarriage in the first trimester
Measured: 12 amenorrhea weeks
Number of late miscarriage
Number of late miscarriage
Measured: between 13 and 24 amenorrhea weeks
Term of birth (for babies without congenital anormality or malformation)
Term of birth
Measured: up to 18 months
Weight at birth
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)
Measured: up to 18 months
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)
Number of prematurity (A birth below 37 weeks of amenorrhea)
Measured: between 28 and 37 amenorrhea weeks
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)
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)
Measured: up to 18 months
Number of pathologic pregnancy included stillbirth and congenital abnormality
Number of pathologic pregnancy included stillbirth and congenital abnormality
Measured: up to 18 months
Investigate if immunologic events studying on endometrial level have an impact on blood level or are independent.
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).
Measured: up to 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2014 (estimated)
- Study start30 Oct 2015
- Primary completion22 Mar 2024
- Study completionApr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Reproductive MedicineStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 493 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nathalie LEDEE, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02262117
- Sponsor's protocol ID
- P130929
- Acronym
- PRECONCEPTIO
- Status last verified
- Oct 2026
- First submitted
- 7 Oct 2014
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Ledee N, Habeichi NJ, Rahmati M, Dray G, Kerkhoven N, Vicaut E, Diallo A, Cassuto NG, Ruoso L, Prat-Ellenberg L, Petitbarat M. Using endometrial immune profiling in young IVF patients: implantation rates improved for morphologically sub-optimal embryos. Front Immunol. 2026 Mar 16;17:1706032. doi: 10.3389/fimmu.2026.1706032. eCollection 2026.
PubMed 41918753Ledee 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.
PubMed 40066441
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Controlled, Two-arm Study to Evaluate the Interest of the Pre-conceptional Endometrial Immune Profiling to Increase Birth Rates Through a Care Personalization in Reproductive Medicine Before IVF
- ClinicalTrials.gov ID
- NCT02262117
- Acronym / sponsor ID
- PRECONCEPTIO / P130929
- Conditions
- Reproductive Medicine
- Keywords
- IVF, immune endometrial profile, treatment personalization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 493 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 30 Oct 2015 (actual)
- Primary completion
- 22 Mar 2024 (actual)
- Study completion
- Apr 2024 (actual)
- First posted
- 10 Oct 2014 (estimated)
- 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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard care | Placebo comparator | Other: standard careNo specific treatment (standard care) |
| specific treatment | Experimental | Drug: specific treatmentAs 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. |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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 signed informed and consent form
- With medical insurance
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| standard careNo specific medical care | Other | standard care |
| specific treatmentRegarding the immune endometrial profiling, medical care (personalization of treatment) should follow a step by step decision tree. | Drug | specific treatment |
Primary outcome
Live birth rate (without congenital abnormality or malformation)/transfer following the first (fresh) embryo transfer after uterine immune analysis
Time frame: up to 18 months
Live birth rate/transfer
12 secondary outcomes
Ongoing pregnancy rate/transfer following the first embryo transfer at 12 weeks of amenorrhea
Time frame: 12 amenorrhea weeks
Number of physiological pregnancies after personalization
Time frame: up to 18 months
Pregnancy rate/transfer following the first embryo transfer
Time frame: 8 amenorrhea weeks
Number of embryo implanted/number of embryos replaced)
Time frame: at 8, 12 and 40 amenorrhea weeks
Number of early miscarriage in the first trimester
Time frame: 12 amenorrhea weeks
Number of late miscarriage
Time frame: between 13 and 24 amenorrhea weeks
Term of birth (for babies without congenital anormality or malformation)
Time frame: up to 18 months
Weight at birth
Time frame: up to 18 months
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)
Time frame: between 28 and 37 amenorrhea weeks
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)
Time frame: up to 18 months
Number of pathologic pregnancy included stillbirth and congenital abnormality
Time frame: up to 18 months
Investigate if immunologic events studying on endometrial level have an impact on blood level or are independent.
Time frame: up to 15 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Derived from this study: PubMed 41918753Ledee N, Habeichi NJ, Rahmati M, Dray G, Kerkhoven N, Vicaut E, Diallo A, Cassuto NG, Ruoso L, Prat-Ellenberg L, Petitbarat M. Using endometrial immune profiling in young IVF patients: implantation rates improved for morphologically sub-optimal embryos. Front Immunol. 2026 Mar 16;17:1706032. doi: 10.3389/fimmu.2026.1706032. eCollection 2026.
- Derived from this study: PubMed 40066441Ledee 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.
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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. This study is not recruiting at the moment.
Nathalie LEDEE, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing specific treatment in people with Reproductive Medicine, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. 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: finished, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Live birth rate (without congenital abnormality or malformation)/transfer following the first (fresh) embryo transfer after uterine immune analysis (time frame: up to 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02262117, which also lists 2 linked publications.
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 16 Oct 2026.