Repeated Embryo Implantation FailureERIMNCT05648136
Immune Profile Analysis and Biomarker Identification in Women With Repeated Implantation Failure or Unexplained Recurrent Spontaneous Miscarriage
A study testing blood sample in people with Repeated Embryo Implantation Failure and Recurrent Miscarriage, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Implantation is a determining step in human reproduction which requires the transition from a pro-inflammatory state to an anti-inflammatory state allowing the implantation of a competent embryo within a receptive endometrium, and then the maternal immunotolerance towards the alloantigenic fetus. Read more about this study
- Who is it for?
- Ages 18 to 39 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Repeated Embryo Implantation Failure, Recurrent Miscarriage, Immune System
- What is being tested?
- blood sample
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 26 Aug 2024to Aug 2026
- 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 39 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- For patients :
- Women aged 18 to 39 years
- women with a history of RIF or unexplained RM
- women with a negative diagnostic work-up (including pelvic ultrasound and hysteroscopy, parental karyotype, thyroid function test, and anti-thyroid and anti-phospholipid antibodies)
- women with a basal FSH level <10IU/l and AMH level >1.5ng/ml
- women with a regular menstrual cycle of 30+/-5 days
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- women receiving a new cycle of in vitro fertilization (IVF) +/- intracytoplasmic sperm injection (ICSI) for patients in the RIF group or a first cycle of IVF +/-ICSI for patients in the RM group
- women received written and oral information and signed an informed consent
- For control groups:
- Controls recruited in the Obstetrics and Gynecology Department with at least one live birth after a spontaneous pregnancy (with a time to conception of less than 12 months for each pregnancy) Voluntary oocyte donors recruited within the CECOS de Picardie (having presented at least one live birth with a delay necessary to conceive of less than 12 months)
- Controls recruited in the Reproductive Medicine and Biology Department having presented at least one live birth (spontaneous with a delay to conceive of less than 12 months for each pregnancy or after one or two MPA procedures) and benefiting from an IVF+/-ICSI procedure for secondary infertility
- Controls recruited in the department of Medicine and Reproductive Biology with a normal infertility assessment and benefiting from an IVF procedure with ICSI on male indication.
Who cannot join
- Ongoing pelvic and/or systemic infection
- Chronic infectious endometritis
- Active neoplasia
- Autoimmune and autoinflammatory disease
- Celiac disease
- Thrombophilia (including positive anti-phospholipid antibodies)
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- Endocrine pathology (including dysthyroidism and diabetes)
- Endometriosis
- Polycystic ovary syndrome and ovulatory disorders
- Premature ovarian failure
- IVF by oocyte donation
- Tubal obstructions or lesions, uterine and cervical anomalies
- Partners with extreme oligoastheno-spermia and/or sperm DNA fragmentation >30
- Sperm donations
- Patients unable to give informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Universitaire d'Amiens
Amiens, Picardie, 80000
Amandine Dernoncourt, DR, 03. 22. 66. 82. 30, dernoncourt.amandine@chu-amiens.fr
About this study
Implantation is a determining step in human reproduction which requires the transition from a pro-inflammatory state to an anti-inflammatory state allowing the implantation of a competent embryo within a receptive endometrium, and then the maternal immunotolerance towards the alloantigenic fetus. Repeat implantation failures (RIFs), that refers to the fail to achieve a clinical pregnancy after the transfer of at least 3-4 good quality embryos or two blastocysts, and unexplained recurrent spontaneous miscarriage (RM) (≥2-3) could be related in some patients to immune imbalances characterized by an excessive and prolonged inflammatory response and/or a defect of anti-inflammatory regulation. In this context, several therapies have been evaluated in patients with RIFs or RMs in order to restore the immune balance, with heterogeneous results. No serum biomarker assay has been routinely approved to identify patients with immune imbalances that may explain repeated pregnancy failures and to predict the success of the subsequent IVF/ICSI cycle. The immunological analysis on peripheral blood will be based on the determination of the proportions of immune subpopulations (e.g. CD4+ et CD8+, TH1, TH2, TH17, Treg, ILC 1, ILC2, and ILC3) on the one hand and the circulating level of plasma cytokines on the other hand.
- Being tested
- blood sample
- Keywords
- repeated embryo implantation failure, recurrent spontaneous miscarriage, immunological analysis, immune system
- Medical subject headings
- Abortion, Habitual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampleBiological
Blood sampling by venipuncture will be performed :
- for patients and controls: between the 20th and 24th day of the menstrual cycle (implantation window) preceding the following IVF+/-ICSI cycle
- for patients receiving an endometrial biopsy: on the same day as the endometrial biopsy
- for patients and controls receiving follicular stimulation for ovarian puncture: the day of the oocyte puncture
- for patients and controls undergoing embryo transfer: on the day of embryo implantation
| Study group | Role | What they receive |
|---|---|---|
| patients | Experimental | * Women aged 18 to 39 years
* with a history of RIF or unexplained RM
* with a negative diagnostic work-up (including pelvic ultrasound and hysteroscopy, parental karyotype, thyroid function test, and anti-thyroid and anti-phospholipid antibodies)
* with a basal FSH level <10IU/l and AMH level >1.5ng/ml
* with a regular menstrual cycle of 30+/-5 days
* receiving a new cycle of in vitro fertilization (IVF) +/- intracytoplasmic sperm injection (ICSI) for patients in the RIF group or a first cycle of IVF +/-ICSI for patients in the RM group
* received written and oral information and signed an informed consent Receives: Biological: blood sample |
| control | Active comparator | * Controls recruited in the Obstetrics and Gynecology Department with at least one live birth after a spontaneous pregnancy (with a time to conception of less than 12 months for each pregnancy) Voluntary oocyte donors recruited within the CECOS de Picardie (having presented at least one live birth with a delay necessary to conceive of less than 12 months)
* Controls recruited in the Reproductive Medicine and Biology Department having presented at least one live birth (spontaneous with a delay to conceive of less than 12 months for each pregnancy or after one or two MPA procedures) and benefiting from an IVF+/-ICSI procedure for secondary infertility
* Controls recruited in the department of Medicine and Reproductive Biology with a normal infertility assessment and benefiting from an IVF procedure with ICSI on male indication. Receives: Biological: blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of the proportion of CD4+ subpopulations between both patient groups
Measured: 18 months
Variation of the proportion of CD8+ subpopulations between both patient groups
Measured: 18 months
Variation of the proportion of TH1 subpopulations between both patient groups
Measured: 18 months
Variation of the proportion of TH2 subpopulations between both patient groups
Measured: 18 months
Variation of the proportion of TH17 subpopulations between both patient groups
Measured: 18 months
Variation of the proportion of Treg subpopulations between both patient groups
Measured: 18 months
Variation of the proportion of ILC 1 subpopulations between both patient groups
Measured: 18 months
Variation of the proportion of ILC 2 subpopulations between both patient groups
Measured: 18 months
Variation of the proportion of ILC 3 subpopulations between both patient groups
Measured: 18 months
Variation of the proportion of TNFα concentrations between both patient groups
Measured: 18 months
Variation of the proportion of IFN gamma concentrations between both patient groups
Measured: 18 months
Variation of the proportion of TGF-β concentrations between both patient groups
Measured: 18 months
Variation of the proportion of IL-10 concentrations between both patient groups
Measured: 18 months
Variation of the proportion of IL-17 concentrations between both patient groups
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2022
- Study start26 Aug 2024
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Repeated Embryo Implantation FailureStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05648136
- Sponsor's protocol ID
- PI2022_843_0077
- Acronym
- ERIM
- Status last verified
- Jun 2026
- First submitted
- 5 Dec 2022
- Last updated
- 11 Jun 2026
- 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 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Profile Analysis and Biomarker Identification in Women With Repeated Implantation Failure or Unexplained Recurrent Spontaneous Miscarriage
- ClinicalTrials.gov ID
- NCT05648136
- Acronym / sponsor ID
- ERIM / PI2022_843_0077
- Keywords
- repeated embryo implantation failure, recurrent spontaneous miscarriage, immunological analysis, immune system
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 26 Aug 2024 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 13 Dec 2022 (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.
Implantation is a determining step in human reproduction which requires the transition from a pro-inflammatory state to an anti-inflammatory state allowing the implantation of a competent embryo within a receptive endometrium, and then the maternal immunotolerance towards the alloantigenic fetus. Repeat implantation failures (RIFs), that refers to the fail to achieve a clinical pregnancy after the transfer of at least 3-4 good quality embryos or two blastocysts, and unexplained recurrent spontaneous miscarriage (RM) (≥2-3) could be related in some patients to immune imbalances characterized by an excessive and prolonged inflammatory response and/or a defect of anti-inflammatory regulation. In this context, several therapies have been evaluated in patients with RIFs or RMs in order to restore the immune balance, with heterogeneous results. No serum biomarker assay has been routinely approved to identify patients with immune imbalances that may explain repeated pregnancy failures and to predict the success of the subsequent IVF/ICSI cycle. The immunological analysis on peripheral blood will be based on the determination of the proportions of immune subpopulations (e.g. CD4+ et CD8+, TH1, TH2, TH17, Treg, ILC 1, ILC2, and ILC3) on the one hand and the circulating level of plasma cytokines on the other hand.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients | Experimental | Biological: blood sample* Women aged 18 to 39 years * with a history of RIF or unexplained RM * with a negative diagnostic work-up (including pelvic ultrasound and hysteroscopy, parental karyotype, thyroid function test, and anti-thyroid and anti-phospholipid antibodies) * with a basal FSH level <10IU/l and AMH level >1.5ng/ml * with a regular menstrual cycle of 30+/-5 days * receiving a new cycle of in vitro fertilization (IVF) +/- intracytoplasmic sperm injection (ICSI) for patients in the RIF group or a first cycle of IVF +/-ICSI for patients in the RM group * received written and oral information and signed an informed consent |
| control | Active comparator | Biological: blood sample* Controls recruited in the Obstetrics and Gynecology Department with at least one live birth after a spontaneous pregnancy (with a time to conception of less than 12 months for each pregnancy) Voluntary oocyte donors recruited within the CECOS de Picardie (having presented at least one live birth with a delay necessary to conceive of less than 12 months) * Controls recruited in the Reproductive Medicine and Biology Department having presented at least one live birth (spontaneous with a delay to conceive of less than 12 months for each pregnancy or after one or two MPA procedures) and benefiting from an IVF+/-ICSI procedure for secondary infertility * Controls recruited in the department of Medicine and Reproductive Biology with a normal infertility assessment and benefiting from an IVF procedure with ICSI on male indication. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- For patients :
- Women aged 18 to 39 years
- women with a history of RIF or unexplained RM
- women with a negative diagnostic work-up (including pelvic ultrasound and hysteroscopy, parental karyotype, thyroid function test, and anti-thyroid and anti-phospholipid antibodies)
- women with a basal FSH level <10IU/l and AMH level >1.5ng/ml
Key exclusion criteria (15 listed)
- Ongoing pelvic and/or systemic infection
- Chronic infectious endometritis
- Active neoplasia
- Autoimmune and autoinflammatory disease
- Celiac disease
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 |
|---|---|---|
| blood sampleBlood sampling by venipuncture will be performed : * for patients and controls: between the 20th and 24th day of the menstrual cycle (implantation window) preceding the following IVF+/-ICSI cycle * for patients receiving an endometrial biopsy: on the same day as the endometrial biopsy * for patients and controls receiving follicular stimulation for ovarian puncture: the day of the oocyte puncture * for patients and controls undergoing embryo transfer: on the day of embryo implantation | Biological | control, patients |
Primary outcome
Variation of the proportion of CD4+ subpopulations between both patient groups
Time frame: 18 months
Variation of the proportion of CD8+ subpopulations between both patient groups
Time frame: 18 months
Variation of the proportion of TH1 subpopulations between both patient groups
Time frame: 18 months
Variation of the proportion of TH2 subpopulations between both patient groups
Time frame: 18 months
Variation of the proportion of TH17 subpopulations between both patient groups
Time frame: 18 months
Variation of the proportion of Treg subpopulations between both patient groups
Time frame: 18 months
Variation of the proportion of ILC 1 subpopulations between both patient groups
Time frame: 18 months
Variation of the proportion of ILC 2 subpopulations between both patient groups
Time frame: 18 months
Variation of the proportion of ILC 3 subpopulations between both patient groups
Time frame: 18 months
Variation of the proportion of TNFα concentrations between both patient groups
Time frame: 18 months
Variation of the proportion of IFN gamma concentrations between both patient groups
Time frame: 18 months
Variation of the proportion of TGF-β concentrations between both patient groups
Time frame: 18 months
Variation of the proportion of IL-10 concentrations between both patient groups
Time frame: 18 months
Variation of the proportion of IL-17 concentrations between both patient groups
Time frame: 18 months
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 11 Jun 2026.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood sample in people with Repeated Embryo Implantation Failure and Recurrent Miscarriage, run by Centre Hospitalier Universitaire, Amiens 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 12 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 11 Jun 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 Amandine Dernoncourt, DR (03. 22. 66. 82. 30, dernoncourt.amandine@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation of the proportion of CD4+ subpopulations between both patient groups (time frame: 18 months). The study lists 14 primary outcomes in all. 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 11 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.