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Dietary Intervention to Improve Fertility in Women With Endometriosis Undergoing IVF
Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
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.
Official title: Randomized Controlled Study on the Effect of a DietAry interveNtion in Ameliorating fertiliTy Parameters in Women With endomEtriosis Undergoing IVF (The DANTE Study)
Key Details
Gender
FEMALE
Age Range
18 Years - 39 Years
Study Type
INTERVENTIONAL
Enrollment
438
Start Date
2025-03-24
Completion Date
2029-12-31
Last Updated
2025-03-27
Healthy Volunteers
No
Conditions
Interventions
anti-inflammatory diet
The anti-inflammatory diet consists of a 12-week plant-based diet, followed by guidance and monitoring from a nutritionist.
Locations (1)
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Italy