Dietary Intervention to Improve Fertility in Women With Endometriosis Undergoing IVF

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.

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	Endometriosis
Enrollment	438 participants
Start Date	2025-03-24
Primary Completion	2029-06-30 (estimated)
Study Completion	2029-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-03-27