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NCT Number: NCT07509411

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

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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This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

19 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Benha university

Banhā, El Qalyoubia, 13511, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Apr 3, 2026
Registry last updated
Apr 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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