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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Active Comparator | 73 infertile women with endometriosis and a history of failed ICSI. |
|
| Control Group | Active Comparator | 72 infertile women with endometriosis and a history of failed ICSI. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TNF-α Inhibitor | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4-6 weeks post-transfer. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At the time of delivery (approximately 9 months post-transfer). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Benha university | Banhā | El Qalyoubia | 13511 | Egypt |
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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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.
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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.
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| Frozen Blastocyst Transfer (FBT) | Procedure | Transfer of a D-5 blastocyst (Grade AA6) following a standardized endometrial preparation involving GnRH-agonist, estradiol valerate, and progesterone. |
|
| D000091662 | Genital Diseases |