Anti-TNFα Therapy for Improving Pregnancy Rates in Endometriosis Patients With Failed ICSI

March 29, 2026 updated by: Basma Sakr, Benha University

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

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 Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

145

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • El Qalyoubia
      • Banhā, El Qalyoubia, Egypt, 13511
        • Benha University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intervention Group
73 infertile women with endometriosis and a history of failed ICSI.
Drug: TNF-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.
Procedure: Frozen Blastocyst Transfer (FBT)
Transfer of a D-5 blastocyst (Grade AA6) following a standardized endometrial preparation involving GnRH-agonist, estradiol valerate, and progesterone.
Active Comparator: Control Group
72 infertile women with endometriosis and a history of failed ICSI.
Procedure: Frozen Blastocyst Transfer (FBT)
Transfer of a D-5 blastocyst (Grade AA6) following a standardized endometrial preparation involving GnRH-agonist, estradiol valerate, and progesterone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Success Rate of Treatment Regimens in Achieving Clinical Pregnancy
Time Frame: 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.
4-6 weeks post-transfer.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success Rate of Treatment in Achieving Healthy Neonatal Outcomes.
Time Frame: 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.
At the time of delivery (approximately 9 months post-transfer).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Benha University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2025

Primary Completion (Actual)

December 15, 2025

Study Completion (Estimated)

October 15, 2026

Study Registration Dates

First Submitted

March 29, 2026

First Submitted That Met QC Criteria

March 29, 2026

First Posted (Actual)

April 3, 2026

Study Record Updates

Last Update Posted (Actual)

April 3, 2026

Last Update Submitted That Met QC Criteria

March 29, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC 3.8.2025

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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