Live Birth Rate After First Embryo Transfer With or Without Glucocorticoid Sensitivity Testing (GLUCO-IVF)

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.

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.

Study Overview

• Status: Completed
• Conditions: Infertility

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 Type: Observational
• Enrollment (Actual): 148

Contacts and Locations

Study Locations

• France
  • Paris, France, 75012
    • Hôpital Pierre Rouquès - Les Bluets

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• • 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From first embryo transfer to delivery (up to approximately 9 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Pregnancy Rate	Clinical pregnancy confirmed by ultrasound visualization of a gestational sac.	Time Frame: 6-8 weeks after embryo transfer
Implantation Rate	Number of gestational sacs per number of embryos transferred.	: 6-8 weeks after embryo transfer
Ongoing Pregnancy Rate	Ongoing pregnancy confirmed by ultrasound visualization of a gestational sac with fetal cardiac activity.	10 weeks after embryo transfer
Miscarriage Rate per Clinical Pregnancy	Pregnancy loss before 24 weeks of gestation among clinical pregnancies.	Up to 24 weeks of gestation

Collaborators and Investigators

• Sponsor: Hopital Pierre Rouques - Les Bluets

Publications and helpful links

General 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.
• Ledee 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): September 17, 2025
• Study Completion (Actual): September 18, 2025

Study Registration Dates

• First Submitted: February 27, 2026
• First Submitted That Met QC Criteria: February 27, 2026
• First Posted (Actual): March 4, 2026

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: February 27, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: IVF; Glucocorticoids; Embryo transfer; Live birth rate; sensitivity testing; uterine immune over-activation
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Infertility
• Other Study ID Numbers: PRS-BLUETS-2020-GLUCO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No