Dietary Intervention to Improve Fertility in Women With Endometriosis Undergoing IVF

Recruiting now · Not applicable

Conditions studied: Endometriosis

In brief

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.

Key facts

Study ID

NCT06885125

Run by

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

People needed

438

Starts

2025-03-24

Expected to finish

2029-12-31

Last updated by the study team

2025-03-27

Who can join

Age: 18 and older, up to 39. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Contraindication to pregnancy
• Hydrosalpinx
• Endometriomas with a mean diameter > 4 cm
• Submucosal fibroids or large intramural or subserosal fibroids (≥ 5 cm).
• Doubtful sonographic findings that do not allow to reliably rule out malignancy.
• severe male factor (<1 million sperm/ml)

Where it is running

• Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico — Milan, Italy (enrolling)

Full record on ClinicalTrials.gov

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