Anti-TNFα Therapy for Improving Pregnancy Rates in Endometriosis Patients With Failed ICSI (NCT07509411) | Clinical Trial Compass
CompletedPhase 2
Anti-TNFα Therapy for Improving Pregnancy Rates in Endometriosis Patients With Failed ICSI
Egypt145 participantsStarted 2025-08-15
Plain-language 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.
Who can participate
Age range
19 Years – 40 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing an anti-TNFα therapy — a type of drug that targets inflammation — alongside ICSI for endometriosis patients who've already had failed ICSI cycles; is that a path worth considering for me given my specific history with ICSI, and do you think my endometriosis is the likely reason my previous cycles didn't work?
2Since this is a Phase 2 trial, the researchers are still building evidence on how safe and effective this anti-TNFα approach is — what do we currently know about the risks of using this type of medication around the time of embryo transfer, and are there any concerns specific to my health history?
3The trial is active but no longer enrolling new participants, so I can't join it right now — but are there similar trials or treatment protocols using anti-inflammatory strategies for endometriosis-related IVF failure that I might be eligible for?
4The main thing this trial is measuring is whether clinical pregnancy rates improve with this approach — if the results become available, how would they change your recommendations for my treatment plan?
5Before considering any experimental approach like this, should I try any standard or updated treatment options for my endometriosis first, and would that potentially improve my chances in a future ICSI cycle on its own?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The Success Rate of Treatment Regimens in Achieving Clinical Pregnancy