Endometriosis
Conditions
Brief 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.
Interventions
DRUGTNF-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.
PROCEDUREFrozen Blastocyst Transfer (FBT)
Transfer of a D-5 blastocyst (Grade AA6) following a standardized endometrial preparation involving GnRH-agonist, estradiol valerate, and progesterone.
Sponsors
Benha University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
There was no masking or blinding involved in this study. Both the participants and the investigators/clinicians were aware that the anti-TNFα therapy was being administered. This is common in preliminary clinical assessments where the goal is to evaluate the feasibility and initial efficacy of a specific medical intervention.
Intervention model description
Participants are assigned to one of two distinct groups (arms) simultaneously. Each group follows a specific protocol throughout the study duration to allow for a direct head-to-head comparison of outcomes.
Eligibility
Sex/Gender
FEMALE
Age
19 Years to 40 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Success Rate of Treatment Regimens in Achieving Clinical Pregnancy | 4-6 weeks post-transfer. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Success Rate of Treatment in Achieving Healthy Neonatal Outcomes. | At the time of delivery (approximately 9 months post-transfer). | A composite measure including live birth rate, birth weight, and absence of major neonatal complications/NICU admissions. |
Countries
Egypt
Outcome results
None listed