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Dietary Intervention to Improve Fertility in Women With Endometriosis Undergoing IVF

Study acronym: DANTE
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Apr 1, 2025 to Mar 24, 2025
    • Site details revised
    v2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this randomized controlled trial is to assess whether a 12-week anti-inflammatory diet can improve fertility outcomes in women with endometriosis undergoing In Vitro Fertilization (IVF). The main questions are: * Does the anti-inflammatory diet reduce the rate of inadequate ovarian response to hormonal stimulation (retrieval of ≤3 oocytes)? * Does it improve secondary outcomes such as embryo quality, pregnancy rates, inflammation markers, and quality of life? Researchers will compare two groups: * Women receiving standard IVF protocols. * Women undergoing the same IVF protocol plus the anti-inflammatory diet. Participants will: * Be randomized into one of the two groups. * Follow dietary counseling sessions and complete dietary assessments (diet group). * Provide biological samples (e.g., plasma, vaginal and fecal swabs, and follicular fluid) before and after the dietary intervention to evaluate potential differences in inflammation, hormonal levels, and microbiome composition between the two groups and across timepoints (pre- and post-diet). * Complete questionnaires on quality of life, sexual function, and symptomatology severity before and after the intervention to assess differences between the two groups and across timepoints.
Trial Details
NCT Number NCT06885125
Lead Sponsor Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Collaborators: Université Catholique de Louvain, Cliniques universitaires Saint-Luc- Université Catholique de Louvain, University of Edinburgh, STICHTING RADBOUD UNIVERSITAIR MEDISCH CENTRUM, UNIWERSYTET MEDYCZNY W LUBLINIE, SVEUCILISTE U ZAGREBU MEDICINSKI FAKULTET, University College Cork, Endometriosis UK, Wageningen University, Endometriose Stichting, Belgian Volition SRL, ASSOCIATION OF PEOPLE WITH ENDOMETRIOSIS I AM 1 IN 10
Conditions
(from sponsor)
Endometriosis
Related terms Endometriosis
Enrollment 438 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov