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

Comparison of Live Birth Rates in Patients With Immune Overactivation Receiving Glucocorticoids With or Without Prior Sensitivity Testing: A Retrospective Cohort Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07449494
Acronym
GLUCO-IVF
Enrollment
148
Registered
2026-03-04
Start date
2020-09-01
Completion date
2025-09-18
Last updated
2026-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

Keywords

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

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.

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.

Interventions

None listed

Sponsors

Hopital Pierre Rouques - Les Bluets
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
No minimum to 40 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Live Birth Rate After First Embryo TransferFrom 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.

Secondary

MeasureTime frameDescription
Clinical Pregnancy RateTime Frame: 6-8 weeks after embryo transferClinical pregnancy confirmed by ultrasound visualization of a gestational sac.
Implantation Rate: 6-8 weeks after embryo transferNumber of gestational sacs per number of embryos transferred.
Ongoing Pregnancy Rate10 weeks after embryo transferOngoing pregnancy confirmed by ultrasound visualization of a gestational sac with fetal cardiac activity.
Miscarriage Rate per Clinical PregnancyUp to 24 weeks of gestationPregnancy loss before 24 weeks of gestation among clinical pregnancies.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026