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

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.

NCT Number	NCT07509411
Lead Sponsor	Benha University
Conditions	Endometriosis
Enrollment	145 participants
Start Date	2025-08-15
Primary Completion	2025-12-15 (estimated)
Study Completion	2026-08-07 (estimated)
Updated on ClinicalTrials.gov	2026-08-11