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Completed

NCT Number: NCT07449494

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

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.

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Key information

Age range

Up to 40 year

Sex eligibility

Female

Study type

Observational

Primary location

Hôpital Pierre Rouquès - Les Bluets

Paris, 75012, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Clinical Pregnancy Rate

    Time frame: Time Frame: 6-8 weeks after embryo transfer

    Clinical pregnancy confirmed by ultrasound visualization of a gestational sac.

  2. Implantation Rate

    Time frame: : 6-8 weeks after embryo transfer

    Number of gestational sacs per number of embryos transferred.

  3. Ongoing Pregnancy Rate

    Time frame: 10 weeks after embryo transfer

    Ongoing pregnancy confirmed by ultrasound visualization of a gestational sac with fetal cardiac activity.

  4. Miscarriage Rate per Clinical Pregnancy

    Time frame: Up to 24 weeks of gestation

    Pregnancy loss before 24 weeks of gestation among clinical pregnancies.

Sponsors and collaborators

Lead sponsor

Hopital Pierre Rouques - Les Bluets

Other

Registry information

Official study title

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

Acronym: GLUCO-IVF

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Mar 4, 2026
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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