Live Birth Rate After First Embryo Transfer With or Without Glucocorticoid Sensitivity Testing

NCT07449494 | Completed

• 1 other identifier: PRS-BLUETS-2020-GLUCO
• Study Type: observational
• Target: 148
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Infertility

Keywords

Glucocorticoids; IVF; Embryo transfer; Live birth rate; sensitivity testing; uterine immune over-activation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Clinical Pregnancy Rate

  Time Frame: 6-8 weeks after embryo transfer

• Implantation Rate

  : 6-8 weeks after embryo transfer

• Ongoing Pregnancy Rate

  10 weeks after embryo transfer

• Miscarriage Rate per Clinical Pregnancy

  Up to 24 weeks of gestation

Study Arms (2)

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.

Eligibility Criteria

• Age: Up to 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hopital Pierre Rouques - Les Bluets: lead

Study Sites (1)

Hôpital Pierre Rouquès - Les Bluets

Paris, 75012, France

Location

Related Publications (2)

• 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.

  PMID: 40066441 BACKGROUND

• 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.

  PMID: 29627619 BACKGROUND

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2026
• First Posted: March 4, 2026
• Study Start: September 1, 2020
• Primary Completion: September 17, 2025
• Study Completion: September 18, 2025
• Last Updated: March 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)