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

NCT07509411 | Completed Phase 2

• 1 other identifier: RC 3.8.2025
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometriosis

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (1)

• Success Rate of Treatment in Achieving Healthy Neonatal Outcomes.

  At the time of delivery (approximately 9 months post-transfer).

Study Arms (2)

Intervention Group

ACTIVE COMPARATOR

73 infertile women with endometriosis and a history of failed ICSI.

Drug: TNF-α Inhibitor; Procedure: Frozen Blastocyst Transfer (FBT)

Control Group

ACTIVE COMPARATOR

72 infertile women with endometriosis and a history of failed ICSI.

Procedure: Frozen Blastocyst Transfer (FBT)

Interventions

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.

Intervention Group

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.

Control Group; Intervention Group

Eligibility Criteria

• Age: 19 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Polycystic Ovary Syndrome (PCOS).
• Inflammatory disorders other than endometriosis.
• Currently maintaining immune-modulating therapies for any other cause.
• Refusal to participate.

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha university

Banhā, El Qalyoubia, 13511, Egypt

Location

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Obstetrics & Gynecology, Faculty of Medicine, Benha University

Model Details: 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.

Study Record Dates

• First Submitted: March 29, 2026
• First Posted: April 3, 2026
• Study Start: August 15, 2025
• Primary Completion: December 15, 2025
• Study Completion: August 7, 2026
• Last Updated: August 11, 2026

Record last verified: 2026-08

Locations

EG (1)