NCT07509411

Anti-TNFα Therapy for Improving Pregnancy Rates in Endometriosis Patients With Failed ICSI

Anti-TNFα Therapy Before Frozen Blastocyst Transfer Might Improve the Clinical Pregnancy Rate for Endometriosis Infertile Women With a Previously Failed ICSI Procedure. A Preliminary Clinical Assessment

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 145 (actual)
• Sponsor: Benha University · Academic / Other
• Sex: Female
• Age: 19 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

This prospective study targets infertile women with endometriosis (EM) who have experienced a previously failed Intracytoplasmic Sperm Injection (ICSI) trial. Using the P-I-C-O framework, the study evaluates whether the administration of an anti-TNF-α therapy (Intervention) 4-5 days before a frozen blastocyst transfer (FBT) improves reproductive outcomes compared to standard protocols (Comparison). The primary outcome is the clinical pregnancy rate, with secondary outcomes focusing on implantation, ongoing pregnancy, and neonatal health. The goal is to determine if mitigating pro-inflammatory cytokines like TNF-α can enhance endometrial receptivity in this specific high-risk population.

Conditions

• Endometriosis

Interventions

Type	Name	Description
DRUG	TNF-α Inhibitor	Administered 4-5 days before the frozen blastocyst transfer. A second session is provided two weeks later only for those with a positive chemical pregnancy diagnosis.
PROCEDURE	Frozen Blastocyst Transfer (FBT)	Transfer of a D-5 blastocyst (Grade AA6) following a standardized endometrial preparation involving GnRH-agonist, estradiol valerate, and progesterone.

Timeline

• Start date: 2025-08-15
• Primary completion: 2025-12-15
• Completion: 2026-10-15
• First posted: 2026-04-03
• Last updated: 2026-04-03

Locations

1 site across 1 country: Egypt