Recurrent Implantation FailureIMERRNCT07265505
Study of Endometrial Immune and Microbiological Modifications in Cases of Recurrent Implantation Failure and/or Recurrent Pregnancy Loss
A study testing Endometrial Biopsy, Vaginal Swab and Blood sample in people with Recurrent Implantation Failure and Recurrent Pregnancy Loss, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The IMERR study aims to improve understanding of certain causes of infertility related to recurrent implantation failure (RIF) and/or recurrent pregnancy loss (RPL), conditions that affect many women undergoing assisted reproductive technology (ART). Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Recurrent Implantation Failure, Recurrent Pregnancy Loss, Infertility, Female
- What is being tested?
- Endometrial Biopsy, Vaginal Swab and Blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2026to Apr 2031
- Phase
- Interventional
- 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 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female aged ≥18 and <36 years
- Undergoing assisted reproductive technology (ART) in a fertility center
- Covered by the French national health insurance system
- Belonging to one of two groups:
- Study group: history of recurrent implantation failure (RIF) and/or recurrent pregnancy loss (RPL)
- Control group: no history of RIF or RPL
Who cannot join
- Pregnant at inclusion
- Refusal to provide written informed consent
- Antibiotic use within one month prior to endometrial biopsy Positive serology for hepatitis B, hepatitis C or HIV
- Uterine anatomical abnormalities (e.g., polyps, cavity-distorting fibroids, untreated hydrosalpinx)
- Known chromosomal abnormality in either partner
- Known autoimmune disease, thrombophilia, or antiphospholipid antibody syndrome
- Persons under legal protection (e.g., guardianship, curatorship)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Marie Benhammani-Godard contact
France1 site
Service de Gynécologie Obstétrique II et Médecine de la Reproduction - Cochin Hospital
Paris, IDF, 75014
Mathilde Bourdon, MD, PhD, 00331 58 41 35 51, marie.godard@aphp.fr
Pietro Santulli, MD, PhD, pietro.santulli@aphp.fr
About this study
Official title: Study of Immune and Microbiological Modifications of the Endometrium in Cases of Recurrent Implantation Failure and/or Recurrent Pregnancy Loss
The IMERR study aims to improve understanding of certain causes of infertility related to recurrent implantation failure (RIF) and/or recurrent pregnancy loss (RPL), conditions that affect many women undergoing assisted reproductive technology (ART). Despite medical advances, some patients repeatedly fail to achieve pregnancy, or experience repeated miscarriages. These situations may be linked to subtle immune or microbial disturbances in the uterus. This study seeks to identify immune and microbiological profiles in the endometrium during the implantation window-a crucial period when the embryo attaches to the uterine wall. We will compare women who have experienced RIF and/or RPL with women who have had no such history. Blood and uterine samples will be analyzed to investigate whether certain immune or microbial features are associated with these reproductive failures. The ultimate goal is to uncover predictive factors that may explain why some women experience implantation failure or pregnancy loss, and to lay the foundation for future personalized treatments to improve reproductive outcomes.
Read the detailed description
The IMERR study is a prospective, monocentric, controlled interventional study aiming to identify immune and microbiological signatures in the eutopic endometrium of women undergoing ART (IVF/ICSI), with and without a history of recurrent implantation failure (RIF) and/or recurrent pregnancy loss (RPL). RIF is defined as the absence of clinical pregnancy after at least three embryo transfers of good-quality blastocysts, and RPL as two or more consecutive pregnancy losses before 24 weeks of gestation.
Participants will be divided into two groups: a study group (with RIF and/or RPL) and a control group (without RIF or RPL). Endometrial biopsies will be collected during the implantation window, alongside peripheral blood and vaginal samples. These samples will undergo immunological and microbiological analyses, including histology, immunophenotyping, and microbiota profiling.
The study aims to (i) Characterize immune cell populations in the endometrium and blood, (ii) Investigate the endometrial microbiome and its potential dysbiosis, (iii) Explore associations between these biological profiles and clinical features such as endometriosis, adenomyosis, chronic endometritis, or uterine contractility disorders.
The study includes 100 participants and spans a total duration of 60 months (36 months for inclusion and 24 months of follow-up). A subgroup analysis will assess the association between immuno-microbiological profiles and clinical outcomes after embryo transfer within the 24-month post-inclusion period.
By identifying predictive markers of RIF and RPL, this study may help establish new diagnostic tools and personalized treatment strategies in reproductive medicine.
- Conditions
- Recurrent Implantation Failure, Recurrent Pregnancy Loss, Infertility, Female, Endometrial Diseases, Endometritis, Endometriosis
- Being tested
- Endometrial Biopsy, Vaginal Swab, Blood sample, Pelvic ultrasound (±pelvic MRI)
- Keywords
- Uterine Immune Profile, Endometrial Receptivity, Infertility, Recurrent Miscarriage, IVF Failure, Implantation Window, Reproductive Immunology, Endometrial Microbiome, Chronic Endometritis, Adenomyosis, Endometriosis
- Medical subject headings
- Infertility, Female, Uterine Diseases, Endometritis, Endometriosis, Adenomyosis, Infertility, Abortion, Habitual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endometrial BiopsyDiagnostic test
Endometrial biopsy with Cornier Pipelle (part of the treatment in the RIF/RPL group and some patients of the control group / added for the research for the other patients of the control group)
Vaginal SwabDiagnostic test
Vaginal sample collection using a cotton swab. Part of the treatment
Blood sampleDiagnostic test
Peripheral blood draw. Part of the treatment + 10 mL additional for research
Pelvic ultrasound (±pelvic MRI)Diagnostic test
Pelvic ultrasound (±pelvic MRI). Part of the treatment
| Study group | Role | What they receive |
|---|---|---|
| RIF/RPL group | Other | Women undergoing ART with a history of recurrent implantation failure (RIF) and/or recurrent pregnancy loss (RPL). Receives: Diagnostic Test: Endometrial Biopsy; Diagnostic Test: Vaginal Swab; Diagnostic Test: Blood sample; Diagnostic Test: Pelvic ultrasound (±pelvic MRI) |
| Control group | Other | Women undergoing ART without a history of RIF or RPL. Receives: Diagnostic Test: Endometrial Biopsy; Diagnostic Test: Vaginal Swab; Diagnostic Test: Blood sample; Diagnostic Test: Pelvic ultrasound (±pelvic MRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Profiling of endometrial immune cell populations
Profiling of endometrial immune cell populations (proportion of subpopulation) during the implantation window using single-cell transcriptomics and/or flow cytometry.
Endometrial biopsies will be collected during the implantation window. Immune cell populations will be characterized using either single-cell RNA sequencing (scRNA-seq) and /or multiparametric flow cytometry, depending on technical feasibility and sample quality. For scRNA-seq, transcriptomic analysis will be performed (e.g., using the 10x Genomics platform), and immune cell types will be identified via clustering and annotation algorithms. For flow cytometry, immune subsets will be identified and quantified based on surface marker expression. Comparisons of immune profiles will be made between women with and without a history of RIF and/or RPL.
Measured: Baseline
Secondary outcomes (4)
Microbiological profiling of endometrial tissue
Microbiological profiling of endometrial tissue during the implantation window using next-generation sequencing (NGS)
Endometrial microbiota will be characterized by next-generation sequencing (NGS) of DNA extracted from endometrial biopsy samples collected during the implantation window. Diversity metrics (alpha and beta diversity) and relative abundances of microbial taxa will be compared between women with and without a history of RIF and/or RPL.
Measured: Baseline
Characterization of peripheral blood immune cell populations
Characterization of peripheral blood immune cell populations during the implantation window using single-cell transcriptomics and/or flow cytometry
Peripheral blood samples will be collected at inclusion. Immune profiling will be performed to characterize circulating immune cell subpopulations. Depending on feasibility and sample quality, either single-cell RNA sequencing (scRNA-seq) and / or multiparametric flow cytometry may be used. Immune profiles will be compared between women with and without a history of RIF and/or RPL.
Measured: Baseline
Exploratory analysis of associations between immune and microbiological profiles and clinical, radiological, and histological characteristics
This outcome consists of exploratory analyses assessing the associations between previously measured immune and microbiological profiles (from endometrial tissue) and (i) clinical outcomes (e.g., pregnancy, miscarriage, live birth), (ii) radiological findings (e.g., adenomyosis, uterine contractility), and (iii) histological/bacteriological findings (e.g., chronic endometritis with CD138+ cells or vaginal cultures). No new biological measurements will be performed. Each association will be reported as a separate statistical outcome (e.g., odds ratios, p-values)
Measured: Baseline
Exploratory analysis of associations between immune and microbiological profiles and clinical, radiological, and histological characteristics
This outcome consists of exploratory analyses assessing the associations between previously measured immune and microbiological profiles (from endometrial tissue) and (i) clinical outcomes (e.g., pregnancy, miscarriage, live birth), (ii) radiological findings (e.g., adenomyosis, uterine contractility), and (iii) histological/bacteriological findings (e.g., chronic endometritis with CD138+ cells or vaginal cultures). No new biological measurements will be performed. Each association will be reported as a separate statistical outcome (e.g., odds ratios, p-values)
Measured: Through 24 months of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study startApr 2026 (estimated)
- Primary completionApr 2029 (estimated)
- Study completionApr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Recurrent Implantation FailureStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, ADREGOF, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Mathilde Bourdon, MD, PhD, Principal investigator, Service de Gynécologie Obstétrique II et Médecine de la Reproduction - Cochin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07265505
- Sponsor's protocol ID
- APHP241344
- Other IDs
- 2024-A02100-47
- Acronym
- IMERR
- Status last verified
- Feb 2026
- First submitted
- 26 May 2025
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Benner M, Ferwerda G, Joosten I, van der Molen RG. How uterine microbiota might be responsible for a receptive, fertile endometrium. Hum Reprod Update. 2018 Jul 1;24(4):393-415. doi: 10.1093/humupd/dmy012.
PubMed 29668899Bourdon M, Santulli P, Jeljeli M, Vannuccini S, Marcellin L, Doridot L, Petraglia F, Batteux F, Chapron C. Immunological changes associated with adenomyosis: a systematic review. Hum Reprod Update. 2021 Jan 4;27(1):108-129. doi: 10.1093/humupd/dmaa038.
PubMed 33099635Campo S, Campo V, Benagiano G. Infertility and adenomyosis. Obstet Gynecol Int. 2012;2012:786132. doi: 10.1155/2012/786132. Epub 2011 Dec 26.
PubMed 22242025Chen P, Chen P, Guo Y, Fang C, Li T. Interaction Between Chronic Endometritis Caused Endometrial Microbiota Disorder and Endometrial Immune Environment Change in Recurrent Implantation Failure. Front Immunol. 2021 Oct 4;12:748447. doi: 10.3389/fimmu.2021.748447. eCollection 2021.
PubMed 34671363Duffy JMN, Adamson GD, Benson E, Bhattacharya S, Bhattacharya S, Bofill M, Brian K, Collura B, Curtis C, Evers JLH, Farquharson RG, Fincham A, Franik S, Giudice LC, Glanville E, Hickey M, Horne AW, Hull ML, Johnson NP, Jordan V, Khalaf Y, Knijnenburg JML, Legro RS, Lensen S, MacKenzie J, Mavrelos D, Mol BW, Morbeck DE, Nagels H, Ng EHY, Niederberger C, Otter AS, Puscasiu L, Rautakallio-Hokkanen S, Sadler L, Sarris I, Showell M, Stewart J, Strandell A, Strawbridge C, Vail A, van Wely M, Vercoe M, Vuong NL, Wang AY, Wang R, Wilkinson J, Wong K, Wong TY, Farquhar CM; Priority Setting Partnership for Infertility. Top 10 priorities for future infertility research: an international consensus development study. Fertil Steril. 2021 Jan;115(1):180-190. doi: 10.1016/j.fertnstert.2020.11.014. Epub 2020 Nov 30.
PubMed 33272617ESHRE Guideline Group on RPL; Bender Atik R, Christiansen OB, Elson J, Kolte AM, Lewis S, Middeldorp S, Mcheik S, Peramo B, Quenby S, Nielsen HS, van der Hoorn ML, Vermeulen N, Goddijn M. ESHRE guideline: recurrent pregnancy loss: an update in 2022. Hum Reprod Open. 2023 Mar 2;2023(1):hoad002. doi: 10.1093/hropen/hoad002. eCollection 2023.
PubMed 36873081ESHRE Working Group on Recurrent Implantation Failure; Cimadomo D, de Los Santos MJ, Griesinger G, Lainas G, Le Clef N, McLernon DJ, Montjean D, Toth B, Vermeulen N, Macklon N. ESHRE good practice recommendations on recurrent implantation failure. Hum Reprod Open. 2023 Jun 15;2023(3):hoad023. doi: 10.1093/hropen/hoad023. eCollection 2023.
PubMed 37332387Giuliani E, Parkin KL, Lessey BA, Young SL, Fazleabas AT. Characterization of uterine NK cells in women with infertility or recurrent pregnancy loss and associated endometriosis. Am J Reprod Immunol. 2014 Sep;72(3):262-9. doi: 10.1111/aji.12259. Epub 2014 May 8.
PubMed 24807109Kunz G, Leyendecker G. Uterine peristaltic activity during the menstrual cycle: characterization, regulation, function and dysfunction. Reprod Biomed Online. 2002;4 Suppl 3:5-9. doi: 10.1016/s1472-6483(12)60108-4.
PubMed 12470555Ledee N, Petitbarat M, Prat-Ellenberg L, Dray G, Cassuto GN, Chevrier L, Kazhalawi A, Vezmar K, Chaouat G. The uterine immune profile: A method for individualizing the management of women who have failed to implant an embryo after IVF/ICSI. J Reprod Immunol. 2020 Nov;142:103207. doi: 10.1016/j.jri.2020.103207. Epub 2020 Sep 14.
PubMed 32971456Marron K, Harrity C. Endometrial lymphocyte concentrations in adverse reproductive outcome populations. J Assist Reprod Genet. 2019 May;36(5):837-846. doi: 10.1007/s10815-019-01427-8. Epub 2019 Mar 7.
PubMed 30847699McQueen DB, Bernardi LA, Stephenson MD. Chronic endometritis in women with recurrent early pregnancy loss and/or fetal demise. Fertil Steril. 2014 Apr;101(4):1026-30. doi: 10.1016/j.fertnstert.2013.12.031. Epub 2014 Jan 23.
PubMed 24462055Ota H, Tanaka T. Stromal vascularization in the endometrium during adenomyosis. Microsc Res Tech. 2003 Mar 1;60(4):445-9. doi: 10.1002/jemt.10282.
PubMed 12567401Pirtea P, Cicinelli E, De Nola R, de Ziegler D, Ayoubi JM. Endometrial causes of recurrent pregnancy losses: endometriosis, adenomyosis, and chronic endometritis. Fertil Steril. 2021 Mar;115(3):546-560. doi: 10.1016/j.fertnstert.2020.12.010. Epub 2021 Feb 11.
PubMed 33581856Rimmer MP, Fishwick K, Henderson I, Chinn D, Al Wattar BH, Quenby S. Quantifying CD138+ cells in the endometrium to assess chronic endometritis in women at risk of recurrent pregnancy loss: A prospective cohort study and rapid review. J Obstet Gynaecol Res. 2021 Feb;47(2):689-697. doi: 10.1111/jog.14585. Epub 2020 Dec 3.
PubMed 33274569
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Immune and Microbiological Modifications of the Endometrium in Cases of Recurrent Implantation Failure and/or Recurrent Pregnancy Loss
- ClinicalTrials.gov ID
- NCT07265505
- Acronym / sponsor ID
- IMERR / APHP241344
- Conditions
- Recurrent Implantation Failure, Recurrent Pregnancy Loss, Infertility, Female, Endometrial Diseases, Endometritis, Endometriosis
- Keywords
- Uterine Immune Profile, Endometrial Receptivity, Infertility, Recurrent Miscarriage, IVF Failure, Implantation Window, Reproductive Immunology, Endometrial Microbiome
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, ADREGOF, URC-CIC Paris Descartes Necker Cochin
- Study start
- Apr 2026 (estimated)
- Primary completion
- Apr 2029 (estimated)
- Study completion
- Apr 2031 (estimated)
- First posted
- 4 Dec 2025 (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.
The IMERR study aims to improve understanding of certain causes of infertility related to recurrent implantation failure (RIF) and/or recurrent pregnancy loss (RPL), conditions that affect many women undergoing assisted reproductive technology (ART). Despite medical advances, some patients repeatedly fail to achieve pregnancy, or experience repeated miscarriages. These situations may be linked to subtle immune or microbial disturbances in the uterus. This study seeks to identify immune and microbiological profiles in the endometrium during the implantation window-a crucial period when the embryo attaches to the uterine wall. We will compare women who have experienced RIF and/or RPL with women who have had no such history. Blood and uterine samples will be analyzed to investigate whether certain immune or microbial features are associated with these reproductive failures. The ultimate goal is to uncover predictive factors that may explain why some women experience implantation failure or pregnancy loss, and to lay the foundation for future personalized treatments to improve reproductive outcomes.
Detailed description
The IMERR study is a prospective, monocentric, controlled interventional study aiming to identify immune and microbiological signatures in the eutopic endometrium of women undergoing ART (IVF/ICSI), with and without a history of recurrent implantation failure (RIF) and/or recurrent pregnancy loss (RPL). RIF is defined as the absence of clinical pregnancy after at least three embryo transfers of good-quality blastocysts, and RPL as two or more consecutive pregnancy losses before 24 weeks of gestation.
Participants will be divided into two groups: a study group (with RIF and/or RPL) and a control group (without RIF or RPL). Endometrial biopsies will be collected during the implantation window, alongside peripheral blood and vaginal samples. These samples will undergo immunological and microbiological analyses, including histology, immunophenotyping, and microbiota profiling.
The study aims to (i) Characterize immune cell populations in the endometrium and blood, (ii) Investigate the endometrial microbiome and its potential dysbiosis, (iii) Explore associations between these biological profiles and clinical features such as endometriosis, adenomyosis, chronic endometritis, or uterine contractility disorders.
The study includes 100 participants and spans a total duration of 60 months (36 months for inclusion and 24 months of follow-up). A subgroup analysis will assess the association between immuno-microbiological profiles and clinical outcomes after embryo transfer within the 24-month post-inclusion period.
By identifying predictive markers of RIF and RPL, this study may help establish new diagnostic tools and personalized treatment strategies in reproductive medicine.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RIF/RPL group | Other | Diagnostic Test: Endometrial Biopsy, Diagnostic Test: Vaginal Swab, Diagnostic Test: Blood sample, Diagnostic Test: Pelvic ultrasound (±pelvic MRI)Women undergoing ART with a history of recurrent implantation failure (RIF) and/or recurrent pregnancy loss (RPL). |
| Control group | Other | Diagnostic Test: Endometrial Biopsy, Diagnostic Test: Vaginal Swab, Diagnostic Test: Blood sample, Diagnostic Test: Pelvic ultrasound (±pelvic MRI)Women undergoing ART without a history of RIF or RPL. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Female aged ≥18 and <36 years
- Undergoing assisted reproductive technology (ART) in a fertility center
- Covered by the French national health insurance system
- Belonging to one of two groups:
Key exclusion criteria (7 listed)
- Pregnant at inclusion
- Refusal to provide written informed consent
- Antibiotic use within one month prior to endometrial biopsy Positive serology for hepatitis B, hepatitis C or HIV
- Uterine anatomical abnormalities (e.g., polyps, cavity-distorting fibroids, untreated hydrosalpinx)
- Known chromosomal abnormality in either partner
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 |
|---|---|---|
| Endometrial BiopsyEndometrial biopsy with Cornier Pipelle (part of the treatment in the RIF/RPL group and some patients of the control group / added for the research for the other patients of the control group) | Diagnostic test | Control group, RIF/RPL group |
| Vaginal SwabVaginal sample collection using a cotton swab. Part of the treatment | Diagnostic test | Control group, RIF/RPL group |
| Blood samplePeripheral blood draw. Part of the treatment + 10 mL additional for research | Diagnostic test | Control group, RIF/RPL group |
| Pelvic ultrasound (±pelvic MRI)Pelvic ultrasound (±pelvic MRI). Part of the treatment | Diagnostic test | Control group, RIF/RPL group |
Primary outcome
Profiling of endometrial immune cell populations
Time frame: Baseline
Profiling of endometrial immune cell populations (proportion of subpopulation) during the implantation window using single-cell transcriptomics and/or flow cytometry. Endometrial biopsies will be collected during the implantation window. Immune cell populations will be characterized using either single-cell RNA sequencing (scRNA-seq) and /or multiparametric flow cytometry, depending on technical feasibility and sample quality. For scRNA-seq, transcriptomic analysis will be performed (e.g., using the 10x Genomics platform), and immune cell types will be identified via clustering and annotation algorithms. For flow cytometry, immune subsets will be identified and quantified based on surface marker expression. Comparisons of immune profiles will be made between women with and without a history of RIF and/or RPL.
4 secondary outcomes
Microbiological profiling of endometrial tissue
Time frame: Baseline
Characterization of peripheral blood immune cell populations
Time frame: Baseline
Exploratory analysis of associations between immune and microbiological profiles and clinical, radiological, and histological characteristics
Time frame: Baseline
Exploratory analysis of associations between immune and microbiological profiles and clinical, radiological, and histological characteristics
Time frame: Through 24 months of follow-up
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 5 Feb 2026.
- Background: PubMed 29668899Benner M, Ferwerda G, Joosten I, van der Molen RG. How uterine microbiota might be responsible for a receptive, fertile endometrium. Hum Reprod Update. 2018 Jul 1;24(4):393-415. doi: 10.1093/humupd/dmy012.
- Background: PubMed 33099635Bourdon M, Santulli P, Jeljeli M, Vannuccini S, Marcellin L, Doridot L, Petraglia F, Batteux F, Chapron C. Immunological changes associated with adenomyosis: a systematic review. Hum Reprod Update. 2021 Jan 4;27(1):108-129. doi: 10.1093/humupd/dmaa038.
- Background: PubMed 22242025Campo S, Campo V, Benagiano G. Infertility and adenomyosis. Obstet Gynecol Int. 2012;2012:786132. doi: 10.1155/2012/786132. Epub 2011 Dec 26.
- Background: PubMed 34671363Chen P, Chen P, Guo Y, Fang C, Li T. Interaction Between Chronic Endometritis Caused Endometrial Microbiota Disorder and Endometrial Immune Environment Change in Recurrent Implantation Failure. Front Immunol. 2021 Oct 4;12:748447. doi: 10.3389/fimmu.2021.748447. eCollection 2021.
- Background: PubMed 33272617Duffy JMN, Adamson GD, Benson E, Bhattacharya S, Bhattacharya S, Bofill M, Brian K, Collura B, Curtis C, Evers JLH, Farquharson RG, Fincham A, Franik S, Giudice LC, Glanville E, Hickey M, Horne AW, Hull ML, Johnson NP, Jordan V, Khalaf Y, Knijnenburg JML, Legro RS, Lensen S, MacKenzie J, Mavrelos D, Mol BW, Morbeck DE, Nagels H, Ng EHY, Niederberger C, Otter AS, Puscasiu L, Rautakallio-Hokkanen S, Sadler L, Sarris I, Showell M, Stewart J, Strandell A, Strawbridge C, Vail A, van Wely M, Vercoe M, Vuong NL, Wang AY, Wang R, Wilkinson J, Wong K, Wong TY, Farquhar CM; Priority Setting Partnership for Infertility. Top 10 priorities for future infertility research: an international consensus development study. Fertil Steril. 2021 Jan;115(1):180-190. doi: 10.1016/j.fertnstert.2020.11.014. Epub 2020 Nov 30.
- Background: PubMed 36873081ESHRE Guideline Group on RPL; Bender Atik R, Christiansen OB, Elson J, Kolte AM, Lewis S, Middeldorp S, Mcheik S, Peramo B, Quenby S, Nielsen HS, van der Hoorn ML, Vermeulen N, Goddijn M. ESHRE guideline: recurrent pregnancy loss: an update in 2022. Hum Reprod Open. 2023 Mar 2;2023(1):hoad002. doi: 10.1093/hropen/hoad002. eCollection 2023.
- Background: PubMed 37332387ESHRE Working Group on Recurrent Implantation Failure; Cimadomo D, de Los Santos MJ, Griesinger G, Lainas G, Le Clef N, McLernon DJ, Montjean D, Toth B, Vermeulen N, Macklon N. ESHRE good practice recommendations on recurrent implantation failure. Hum Reprod Open. 2023 Jun 15;2023(3):hoad023. doi: 10.1093/hropen/hoad023. eCollection 2023.
- Background: PubMed 24807109Giuliani E, Parkin KL, Lessey BA, Young SL, Fazleabas AT. Characterization of uterine NK cells in women with infertility or recurrent pregnancy loss and associated endometriosis. Am J Reprod Immunol. 2014 Sep;72(3):262-9. doi: 10.1111/aji.12259. Epub 2014 May 8.
- Background: PubMed 12470555Kunz G, Leyendecker G. Uterine peristaltic activity during the menstrual cycle: characterization, regulation, function and dysfunction. Reprod Biomed Online. 2002;4 Suppl 3:5-9. doi: 10.1016/s1472-6483(12)60108-4.
- Background: PubMed 32971456Ledee N, Petitbarat M, Prat-Ellenberg L, Dray G, Cassuto GN, Chevrier L, Kazhalawi A, Vezmar K, Chaouat G. The uterine immune profile: A method for individualizing the management of women who have failed to implant an embryo after IVF/ICSI. J Reprod Immunol. 2020 Nov;142:103207. doi: 10.1016/j.jri.2020.103207. Epub 2020 Sep 14.
- Background: PubMed 30847699Marron K, Harrity C. Endometrial lymphocyte concentrations in adverse reproductive outcome populations. J Assist Reprod Genet. 2019 May;36(5):837-846. doi: 10.1007/s10815-019-01427-8. Epub 2019 Mar 7.
- Background: PubMed 24462055McQueen DB, Bernardi LA, Stephenson MD. Chronic endometritis in women with recurrent early pregnancy loss and/or fetal demise. Fertil Steril. 2014 Apr;101(4):1026-30. doi: 10.1016/j.fertnstert.2013.12.031. Epub 2014 Jan 23.
- Individual participant dataSharing planned: Undecided
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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.
Marie Benhammani-Godard contact
Mathilde Bourdon, MD, PhD principal investigator
Service de Gynécologie Obstétrique II et Médecine de la Reproduction - Cochin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endometrial Biopsy, Vaginal Swab and Blood sample in people with Recurrent Implantation Failure and Recurrent Pregnancy Loss, 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 7 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: opening soon, as of the sponsor's last update on 5 Feb 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. 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 Mathilde Bourdon, MD, PhD (00331 58 41 35 51, mathilde.bourdon@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Profiling of endometrial immune cell populations (time frame: Baseline). 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 NCT07265505, which also lists 19 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 5 Feb 2026.