NCT07509411CompletedPhase 2
Anti-TNFα Therapy for Improving Pregnancy Rates in Endometriosis Patients With Failed ICSI
Anti-TNFα Therapy Before Frozen Blastocyst Transfer Might Improve the Clinical Pregnancy Rate for Endometriosis Infertile Women With a Previously Failed ICSI Procedure. A Preliminary Clinical Assessment
Source: ClinicalTrials.gov · Last updated 11 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 145 (actual)
- First submitted
- 29 Mar 2026
- Start date
- 15 Aug 2025
- Primary completion date
- 15 Dec 2025
- Lead sponsor
- Benha University
- Diseases
- Endometriosis
- NCT number
- NCT07509411
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 145
- From 15 Aug 2025 to the primary completion date, 15 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently maintaining immune-modulating therapies for any other cause.
Other illness
- Polycystic Ovary Syndrome (PCOS).
- Inflammatory disorders other than endometriosis.
Other
- Refusal to participate.
Who the study is looking for
- 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.
Age in the registry: 19 years to 40 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Benha University Coordinator of this site? Confirm its status | Banhā | Egypt | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.