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Completed
NCT07509411
Anti-TNFα Therapy for Improving Pregnancy Rates in Endometriosis Patients With Failed ICSI
Conditions: Endometriosis
Sex: Female
Ages: 19 Years – 40 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 145
Sponsor: Benha University
Location: Benha university Banhā El Qalyoubia
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.
Eligibility Criteria
Inclusion Criteria:
* Endometriosis diagnosed during infertility workup.
* History of a previously failed ICSI trial.
* Presence of more than one frozen embryo at the D-5 blastocyst stage qualified as good quality (Grade AA6).
* Signed informed consent.
Exclusion Criteria:
* Polycystic Ovary Syndrome (PCOS).
* Inflammatory disorders other than endometriosis.
* Currently maintaining immune-modulating therapies for any other cause.
* Refusal to participate.
Source: ClinicalTrials.gov (NCT07509411). StuddyBuddy aggregates publicly available trial information.