A Phase 2 interventional study of TNF-α Inhibitor and Frozen Blastocyst Transfer (FBT) in Endometriosis, sponsored by Benha University. Completed at 1 site in Egypt. Open to female participants aged 19 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-08-11.
Sponsored by Benha University · Phase 2, Interventional, and Treatment
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.
901 studies on the registry are indexed under Endometriosis; 259 are open to participants now.
This study's enrollment of 145 is above the median of 64 across 525 interventional studies indexed under Endometriosis.
Browse Endometriosis studies →Benha University is the lead sponsor of 356 studies on the registry; 68 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
73 infertile women with endometriosis and a history of failed ICSI.
Drug: TNF-α Inhibitor · Procedure: Frozen Blastocyst Transfer (FBT)
72 infertile women with endometriosis and a history of failed ICSI.
Procedure: Frozen Blastocyst Transfer (FBT)
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.
Transfer of a D-5 blastocyst (Grade AA6) following a standardized endometrial preparation involving GnRH-agonist, estradiol valerate, and progesterone.
The Success Rate of Treatment Regimens in Achieving Clinical Pregnancy
The proportion of patients who achieved a clinical pregnancy (confirmed by ultrasound visualization of a gestational sac with fetal heart activity) following frozen blastocyst transfer, reflecting the effectiveness of the administered anti- TNFα therapy.
Time frame: 4-6 weeks post-transfer.
Success Rate of Treatment in Achieving Healthy Neonatal Outcomes.
A composite measure including live birth rate, birth weight, and absence of major neonatal complications/NICU admissions.
Time frame: At the time of delivery (approximately 9 months post-transfer).
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Benha University