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Anti-TNFα Therapy for Improving Pregnancy Rates in Endometriosis Patients With Failed ICSI
Sponsor: Benha University
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.
Official title: 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
Key Details
Gender
FEMALE
Age Range
19 Years - 40 Years
Study Type
INTERVENTIONAL
Enrollment
145
Start Date
2025-08-15
Completion Date
2026-10-15
Last Updated
2026-04-03
Healthy Volunteers
No
Conditions
Interventions
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.
Frozen Blastocyst Transfer (FBT)
Transfer of a D-5 blastocyst (Grade AA6) following a standardized endometrial preparation involving GnRH-agonist, estradiol valerate, and progesterone.
Locations (1)
Benha university
Banhā, El Qalyoubia, Egypt