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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
145
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.
Benha university
Banhā, El Qalyoubia, Egypt
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).
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