InfertilityGLUCO-IVFNCT07449494
Live Birth Rate After First Embryo Transfer With or Without Glucocorticoid Sensitivity Testing
An observational study of Infertility, run by Hopital Pierre Rouques - Les Bluets at 1 site in France.
Trial summary
This retrospective single-center observational cohort study evaluates live birth rates after the first embryo transfer following immune assessment in infertile women with documented uterine immune overactivation. In routine clinical practice, glucocorticoids represent first-line therapy for immune overactivation. Read more about this study
- Who is it for?
- Ages Up to 40 years, women only
- Conditions the study is for
- Infertility
- How many people
- 148 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2020to 18 Sep 2025
- Phase
- Observational
- 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 Up to 40 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: The study population consists of infertile women aged 40 years or younger undergoing in vitro fertilization (IVF) with a planned fresh or frozen blastocyst transfer at Hôpital Pierre Rouquès - Les Bluets (Paris, France). All patients had documented uterine immune overactivation identified through routine immune assessment prior to embryo transfer. Patients were managed according to standard clinical practice, with first-line glucocorticoid therapy, with or without prior glucocorticoid sensitivity testing.
Who may be able to join
- Infertile patients undergoing IVF with planned fresh or frozen embryo transfer
- Age ≤ 40 years at the time of the transfer
- Documented uterine immune over-activation
- Treatment with glucocorticoids in routine clinical practice, with or without prior glucocorticoid sensitivity testing
- Fresh or frozen blastocyst transfer performed within 9 months following immune assessment at Hôpital des Bluets
Who cannot join
- • Age > 40 years
- No available uterine immune profile
- Normal immune profile or immune underactivation
- Management exclusively with alternative therapeutic strategies (e.g., low molecular weight heparin [LMWH], intralipid therapy) or combination therapies (e.g., LMWH + glucocorticoids or intralipid + glucocorticoids)
- Embryo transfer performed more than 9 months after immune assessment
- Cleavage-stage embryo transfer
- Embryo transfer performed in another center
- Oocyte donation IVF cycles
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Live Birth Rates in Patients With Immune Overactivation Receiving Glucocorticoids With or Without Prior Sensitivity Testing: A Retrospective Cohort Study
This retrospective single-center observational cohort study evaluates live birth rates after the first embryo transfer following immune assessment in infertile women with documented uterine immune overactivation.
In routine clinical practice, glucocorticoids represent first-line therapy for immune overactivation. Some patients underwent glucocorticoid sensitivity testing prior to embryo transfer based solely on standard clinical practice and patient preference. In cases of demonstrated glucocorticoid resistance, alternative therapeutic strategies were implemented according to usual care.
Read more
The study analyzes clinical data collected between September 2020 and November 2025 to assess the association between prior glucocorticoid sensitivity testing and live birth rate after the first fresh or frozen blastocyst transfer performed following immune evaluation.
No treatment allocation was determined by a study protocol.
Read the detailed description
This retrospective single-center cohort study was conducted at Hôpital Pierre Rouquès - Les Bluets (Paris, France) and includes infertile women aged 40 years or younger undergoing in vitro fertilization (IVF) between September 2020 and November 2025.
All included patients had documented uterine immune overactivation identified through routine immune assessment prior to embryo transfer. In standard clinical practice at our center, glucocorticoids represent first-line therapy for immune overactivation.
Some patients underwent glucocorticoid sensitivity testing prior to embryo transfer, based solely on routine clinical practice and patient preference. In cases of demonstrated glucocorticoid resistance, alternative therapeutic strategies were implemented according to standard care.
The study compares live birth rates following the first fresh or frozen blastocyst transfer performed after immune evaluation in patients managed with or without prior glucocorticoid sensitivity testing.
This study is purely observational and retrospective. No treatment allocation or testing decision was determined by a study protocol.
- Conditions
- Infertility
- Keywords
- Glucocorticoids, IVF, Embryo transfer, Live birth rate, sensitivity testing, uterine immune over-activation
- 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 |
|---|---|---|
| No Sensitivity Testing | Patients with documented uterine immune overactivation managed with first-line glucocorticoid therapy in routine clinical practice without prior glucocorticoid sensitivity testing. | |
| Sensitivity Testing | Patients with documented uterine immune overactivation who underwent glucocorticoid sensitivity testing prior to embryo transfer. In cases of glucocorticoid resistance, alternative therapeutic strategies were implemented according to routine clinical practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live Birth Rate After First Embryo Transfer
Live birth defined as delivery of a viable infant beyond 24 weeks of gestation, assessed after the first fresh or frozen blastocyst transfer performed following immune evaluation.
Measured: From first embryo transfer to delivery (up to approximately 9 months)
Secondary outcomes (4)
Clinical Pregnancy Rate
Clinical pregnancy confirmed by ultrasound visualization of a gestational sac.
Measured: Time Frame: 6-8 weeks after embryo transfer
Implantation Rate
Number of gestational sacs per number of embryos transferred.
Measured: : 6-8 weeks after embryo transfer
Ongoing Pregnancy Rate
Ongoing pregnancy confirmed by ultrasound visualization of a gestational sac with fetal cardiac activity.
Measured: 10 weeks after embryo transfer
Miscarriage Rate per Clinical Pregnancy
Pregnancy loss before 24 weeks of gestation among clinical pregnancies.
Measured: Up to 24 weeks of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start1 Sep 2020
- Primary completion17 Sep 2025
- Study completion18 Sep 2025
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 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Pierre Rouques - Les Bluets
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07449494
- Sponsor's protocol ID
- PRS-BLUETS-2020-GLUCO
- Acronym
- GLUCO-IVF
- Status last verified
- Feb 2026
- First submitted
- 27 Feb 2026
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ledee 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 40066441Ledee N, Prat-Ellenberg L, Petitbarat M, Chevrier L, Simon C, Irani EE, Vitoux D, Bensussan A, Chaouat G. Impact of prednisone in patients with repeated embryo implantation failures: Beneficial or deleterious? J Reprod Immunol. 2018 Jun;127:11-15. doi: 10.1016/j.jri.2018.03.003. Epub 2018 Mar 26.
PubMed 29627619
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Live Birth Rates in Patients With Immune Overactivation Receiving Glucocorticoids With or Without Prior Sensitivity Testing: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT07449494
- Acronym / sponsor ID
- GLUCO-IVF / PRS-BLUETS-2020-GLUCO
- Conditions
- Infertility
- Keywords
- Glucocorticoids, IVF, Embryo transfer, Live birth rate, sensitivity testing, uterine immune over-activation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Hopital Pierre Rouques - Les BluetsUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 17 Sep 2025 (actual)
- Study completion
- 18 Sep 2025 (actual)
- First posted
- 4 Mar 2026 (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.
This retrospective single-center observational cohort study evaluates live birth rates after the first embryo transfer following immune assessment in infertile women with documented uterine immune overactivation.
In routine clinical practice, glucocorticoids represent first-line therapy for immune overactivation. Some patients underwent glucocorticoid sensitivity testing prior to embryo transfer based solely on standard clinical practice and patient preference. In cases of demonstrated glucocorticoid resistance, alternative therapeutic strategies were implemented according to usual care.
The study analyzes clinical data collected between September 2020 and November 2025 to assess the association between prior glucocorticoid sensitivity testing and live birth rate after the first fresh or frozen blastocyst transfer performed following immune evaluation.
No treatment allocation was determined by a study protocol.
Detailed description
This retrospective single-center cohort study was conducted at Hôpital Pierre Rouquès - Les Bluets (Paris, France) and includes infertile women aged 40 years or younger undergoing in vitro fertilization (IVF) between September 2020 and November 2025.
All included patients had documented uterine immune overactivation identified through routine immune assessment prior to embryo transfer. In standard clinical practice at our center, glucocorticoids represent first-line therapy for immune overactivation.
Some patients underwent glucocorticoid sensitivity testing prior to embryo transfer, based solely on routine clinical practice and patient preference. In cases of demonstrated glucocorticoid resistance, alternative therapeutic strategies were implemented according to standard care.
The study compares live birth rates following the first fresh or frozen blastocyst transfer performed after immune evaluation in patients managed with or without prior glucocorticoid sensitivity testing.
This study is purely observational and retrospective. No treatment allocation or testing decision was determined by a study protocol.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Sensitivity Testing | – | –Patients with documented uterine immune overactivation managed with first-line glucocorticoid therapy in routine clinical practice without prior glucocorticoid sensitivity testing. |
| Sensitivity Testing | – | –Patients with documented uterine immune overactivation who underwent glucocorticoid sensitivity testing prior to embryo transfer. In cases of glucocorticoid resistance, alternative therapeutic strategies were implemented according to routine clinical practice. |
Who may qualify
- Ages
- Up to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The study population consists of infertile women aged 40 years or younger undergoing in vitro fertilization (IVF) with a planned fresh or frozen blastocyst transfer at Hôpital Pierre Rouquès - Les Bluets (Paris, France). All patients had documented uterine immune overactivation identified through routine immune assessment prior to embryo transfer. Patients were managed according to standard clinical practice, with first-line glucocorticoid therapy, with or without prior glucocorticoid sensitivity testing.
Key inclusion criteria (5 listed)
- Infertile patients undergoing IVF with planned fresh or frozen embryo transfer
- Age ≤ 40 years at the time of the transfer
- Documented uterine immune over-activation
- Treatment with glucocorticoids in routine clinical practice, with or without prior glucocorticoid sensitivity testing
- Fresh or frozen blastocyst transfer performed within 9 months following immune assessment at Hôpital des Bluets
Key exclusion criteria (8 listed)
- • Age > 40 years
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 After First Embryo Transfer
Time frame: From first embryo transfer to delivery (up to approximately 9 months)
Live birth defined as delivery of a viable infant beyond 24 weeks of gestation, assessed after the first fresh or frozen blastocyst transfer performed following immune evaluation.
4 secondary outcomes
Clinical Pregnancy Rate
Time frame: Time Frame: 6-8 weeks after embryo transfer
Implantation Rate
Time frame: : 6-8 weeks after embryo transfer
Ongoing Pregnancy Rate
Time frame: 10 weeks after embryo transfer
Miscarriage Rate per Clinical Pregnancy
Time frame: Up to 24 weeks of gestation
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 4 Mar 2026.
- Background: 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.
- Background: PubMed 29627619Ledee N, Prat-Ellenberg L, Petitbarat M, Chevrier L, Simon C, Irani EE, Vitoux D, Bensussan A, Chaouat G. Impact of prednisone in patients with repeated embryo implantation failures: Beneficial or deleterious? J Reprod Immunol. 2018 Jun;127:11-15. doi: 10.1016/j.jri.2018.03.003. Epub 2018 Mar 26.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, run by Hopital Pierre Rouques - Les Bluets 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 5 inclusion and 8 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 4 Mar 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?
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 After First Embryo Transfer (time frame: From first embryo transfer to delivery (up to approximately 9 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 NCT07449494, 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 4 Mar 2026.