Randomized Controlled Study on the Effect of a DietAry interveNtion in Ameliorating fertiliTy Parameters in Women With endomEtriosis Undergoing IVF (The DANTE Study)

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 39
Healthy Volunteers: f
View:

• Age \< 40 years

• Pregnancy seeking for more than 12 months

• Regular menstrual cycle, i.e. mean cycle interval between 21 and 35 days

• Ultrasonographic diagnosis of ovarian endometriomas or deep peritoneal endometriosis.

• Antral Follicle Counts (AFC) ≥ 5 (no other cause of reduced ovarian reserve).

• Absence of ureteral stenosis or intestinal subocclusive symptoms

Locations
Other Locations
Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
RECRUITING
Milan
Contact Information
Primary
Paola Vigano', PhD
paola.vigano@policlinico.mi.it
+390255034302
Backup
Marco Reschini, MSc
marco.reschini@policlinico.mi.it
+390255034303
Time Frame
Start Date: 2025-03-24
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 438
Treatments
Experimental: Anti-Inflammatory Diet
Patients will follow a 12-week anti-inflammatory diet, followed by the standard IVF treatment protocol.
No_intervention: Controls
Patients will undergo the standard IVF treatment protocol without any dietary intervention.
Related Therapeutic Areas
Sponsors
Collaborators: University of Edinburgh, University College Cork, Endometriosis UK, Cliniques universitaires Saint-Luc- Université Catholique de Louvain, STICHTING RADBOUD UNIVERSITAIR MEDISCH CENTRUM, Belgian Volition SRL, ASSOCIATION OF PEOPLE WITH ENDOMETRIOSIS I AM 1 IN 10, UNIVERSITE CATHOLIQUE DE LOUVAIN, UNIWERSYTET MEDYCZNY W LUBLINIE, Endometriose Stichting, Wageningen University, SVEUCILISTE U ZAGREBU MEDICINSKI FAKULTET
Leads: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

This content was sourced from clinicaltrials.gov