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NCT07509411
Anti-TNFα Therapy for Improving Pregnancy Rates in Endometriosis Patients With Failed ICSI
Phase 2 trial testing TNF-α Inhibitor in Endometriosis in 145 participants. Participants enrolled and being followed up; not accepting new ones.
15 December 2025
Quick facts
| Lead sponsor | Benha University |
|---|---|
| Phase | Phase 2 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 145 |
| Start date | 15 August 2025 |
| Primary completion | 15 December 2025 |
| Estimated completion | 15 October 2026 |
| Sites | 1 location across Egypt |
Drugs / interventions tested
- TNF-α Inhibitor
- Frozen Blastocyst Transfer (FBT)
Conditions studied
- Endometriosis — all drugs for Endometriosis →
Sponsor
Benha University
Who can join
Adults 19 to 40, female only, with Endometriosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07509411
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07509411 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Benha University
- Last refreshed: 3 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07509411.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing